Business Unit Head (OTC)

Business Unit Head - Pharma & Medical Device

Customer Service Assistant Manager

Regulatory Affairs Professional (Product Regulatory Expert)

Business Development Lead (Global Role)

Regulatory Affairs Manager

Associate I, Quality Operations

Specialist, DEA Compliance

QC Supervisor

BU Manager/ Head - CVM, Gastro, Women Health & Medical device

Responsibilities: <ul><li>Experience in sales and marketing, specifically in the pharmaceutical and consumer goods sectors.</li><li>Key Account Management (KAM) experience, with a focus on product management and brand management.</li><li>Proven track record in sales and marketing within the Over-The-Counter (OTC) and consumer healthcare segments.</li><li>Expertise in managing teams, developing brands, and executing brand-building strategies.</li><li>Strong understanding of consumer health trends and the ability to drive marketing initiatives to align with market demands.</li><li>Ability to collaborate cross-functionally to support business growth and expand market presence.</li></ul> Requirements: <ul><li>Bachelor’s degree in Marketing, Business, or a related field (MBA preferred).</li><li>7+ years of experience in sales and marketing within the pharmaceutical, OTC, or consumer goods industries.</li><li>Demonstrated experience in Key Account Management, product management, and brand management.</li><li>Proven ability to lead and manage teams, with experience in developing and executing brand-building strategies.</li><li>Strong understanding of the consumer healthcare sector and OTC products.</li></ul>

Responsibilities: <ul><li>Articulate a clear vision for the business unit based on company objectives.&nbsp;</li><li>Responsible to define the strategy of BU based on market opportunities, customer needs and therapeutic franchise goals.&nbsp;</li><li>Deliver BU objectives and build a solid Annual Brand Plans, including revenue growth and financial target, commercial execution, profitability, expense control, process optimization, productivity, employee development, and customer satisfaction.</li><li>Collaborate with the Commercial Excellence team for forecasting &amp; analytics to develop appropriate forecasts to drive commercial success and accuracy.</li><li>Improving result by monitoring key operational metrics, measurements, and targets.</li><li>Develop strategy to manage and engage Key Opinion Leaders and key customers of our products, maintenance strong relationship with them.&nbsp;</li><li>Provide leadership and support to team, establish and lead high-performance team which includes talent identification, development plans and succession plans.</li></ul> Requirements: <ul><li>University Degree with Science education ( eg: pharmacy, medicine ). MBA is advantage.&nbsp;</li><li>A minimum 15 years successful sales and marketing experience in pharmaceutical, healthcare, medical devices both sales and marketing with mixed local pharmaceutical and global pharmaceutical experiences. </li><li>At least 8 year must be in managerial position.&nbsp;</li><li>Extensive experience in portfolio of Cardiovascular &amp; Metabolic, or Gastrointestinal, or Ob&amp;Gyn or Respiratory, or Neuroscience or Paediatric or Medical Device.&nbsp;</li><li>Ensure compliance with appropriate SOP’s, policies and guidelines.</li><li>Preferable someone with close engagement with multi medical association including internal medicines, gastrohepatologist, endocrinologist, cardiologist, neurologist, obstetric and gynaecologist, and surgeon.&nbsp;</li><li>Possesses strong understanding of market and sales strategy. Track record in defining, planning and shaping strategies and initiatives that set direction for business unit and/or function.</li><li>Proven successful track records in achieving sales target with entrepreneurial mindset.</li><li>Experience involving managing financial performance, P&amp;L responsibilities.</li><li>Experience with significant people demands, track record of attracting &amp; developing talent, developing bench strengths and managing complex, diverse and remote workforce (People Management &amp; development of team)</li><li>Client Interface</li></ul> Key Working Relationships <ul><li>Local and International KOLs</li><li>Main National &amp; Regional stakeholders</li><li>Medical societies and patient associations</li><li>Internal stakeholders incl. Medical Affairs, RA, Patient Access, Commercial Excellence &amp; HQ team</li></ul>

Responsibilities:Serve as a liaison for the customer when interacting within Customer Service as well as Sales, Commercial Operations, Distribution, Finance, and other departments.In addition, have a high-level understanding of the general processes within the departments and how they interrelate to Customer Service and impact other internal stakeholders.Provide support within Customer Service, responding to customer requests, inquiries, etc.In a compliant, expedient, and professional manner, with ability to manage or coordinate all inquiries to achieve complete resolution and full customer satisfaction.Aid in the managing and processing of orders received via various communication channels in a prompt and correct manner.Exercise full authority to perform pricing review in preparation of order entry, enter orders directly into SAP environment, and aid in maintaining a central customer database.Seek continuous process improvements to enhance department productivity and customer service performance.Investigate and resolve customer submitted claims, including but not limited to shortages, damages, overages, failure to supply.Prepare and present a variety of reports, including explanation of variances, significant trends, and recommendations for change or resolution.Preparing ad hoc service and sales related reports for internal and external customers.Work with internal teams to ensure compliance with client performance guarantees, and regulatory or accreditation standards.Assist in managing complex customer issues escalated by team members.Participate in daily, weekly and ad hoc cross-functional meetings to discuss and resolve operational and technical issues.Participate in training and follow in various SOP’s trainings (company & departmental) and perform other departmental duties as assigned.Requirements:Bachelor’s Degree from an accredited college or university and/or equivalent experience.7+ years experience in the pharmaceutical industry.7+ years experience in a Customer Service-related environment.Proficient with Microsoft Office Suite (Heavy Outlook & Excel Usage).SAP knowledge required.Controlled Product Experience preferred.Knowledge of all aspects of customer service etiquette.Ability to enter, prepare and analyze data accurately.Experience with SAP OTC TCodes.Understanding of regulatory agency requirements and how they affect our daily functions.Demonstrated ability to prioritize multiple tasks, solve complex problems, drive resolution of problems to meet deadlines, and diligence as related to details.Strong interpersonal, verbal, and written communication skills, including the ability to communicate clearly, effectively and professionally with customers and all levels of the organizationSituational analysis and independent thinking skills.Exceptional attendance required to meet ongoing departmental and customer demands.Flexibility to work in a team setting or independently, depending on needs of the department.Ability to execute projects, both individually and cross-functionally.Ability to work with minimal direction, rapidly understand the context, the task and take quick initiative to resolve problems.Strong ability to organize, prioritize, and manage time effectively.History of improving processes and increasing efficiencies.Results driven.

Responsibilities:Work closely with Quality Assurance to obtain regulatory documentation required to maintain drug master files (DMFs)Prepare and submit annual updates and amendments for DMFs to global regulatory agencies in accordance with the regulatory agencies’ guidelines.Engage with and monitor external consultants utilized for submissions.Track regulatory submissions to ensure timely filings in accordance with regional regulatory requirements.Maintain regulatory records, including archiving of regulatory submissions.Work closely with Product Stewards, Quality and project teams to outline regulatory requirements, costs, and timelines for new DMFs required to support new or expanding products.Acquire in-depth knowledge of company current and developing portfolio of products used in the regulated markets mentioned above in order to answer compliance related questions from internal partners,external parties, and add value to existing and new customer engagement discussions.Maintain awareness of global regulatory legislation and its impact on company products and businessProvide appropriate information to promote the safe use of company products throughout their entire life-cycle to:External Stakeholders – including customers, distributors, and industry partnersInternal Stakeholders - including Product Stewards and SMEs, manufacturing, technology, product management, and sales & marketing personnelDevelop/maintain a sound awareness of global trends in pharmaceutical regulations.Prepare responses for customer inquiries.Execute reviews/approvals for new product reg tox and commercialization requests related to applications in regulated markets.Assist with special projects related to Product Stewardship & Regulatory Affairs, as needed.Learn other areas within the Food, Drug, Device, Cosmetic (FDDC) Regulations to provide support to the FDDC team.Requirements:Minimum of Bachelor’s degree (or higher) required.2 – 5+ years of experience in a regulatory affairs role.

Job Summary:We are seeking a dynamic and results-driven Business Development Lead with a minimum of 2 to 3 years of experience to join our team. The ideal candidate will have a background in healthcare (Pharma or Devices), This role involves significant exposure to in-licensing and out-licensing and will encompass both global responsibilities and a strong emphasis on marketing over sales. The role is pivotal in driving revenue growth, managing client relationships, and supporting devices, formulations, and OTC products, with a great emphasis on niche and unique product opportunities.Responsibilities:Business Development:Identify and pursue new business opportunities in the healthcare (Devices) sectors through market research, networking, and cold outreach.Develop and implement strategic business development plans to achieve company goals and targets on a global scale.Conduct competitive analysis and market research to stay abreast of industry trends and opportunities, particularly in the devices sector.Client Relationship Management:Build and maintain strong relationships with key clients and partners globally.Understand client needs and provide tailored solutions to meet their requirements.Ensure high levels of client satisfaction and retention.Sales Drive the sales process from lead generation to closing deals, with a significant focus on marketing initiatives.Prepare and deliver compelling presentations and proposals to potential clients.Negotiate contracts and agreements, with exposure to in-licensing and out-licensing.Collaboration and Communication:Work closely with the marketing, product, and operations, medical and regulatory teams to align business development efforts with overall company strategy.Provide regular updates and reports on business development activities and outcomes.Represent the company at industry events, conferences, and trade shows.Marketing Focus:Develop and execute marketing strategies to promote products and services, with a heavier weightage on marketing activities compared to sales.Create and manage marketing campaigns to drive brand awareness and generate leads.Requirements:MBA with a focus on healthcare and commercial operations.2 to 3 years of experience in business development, sales, or a related role in the healthcare or pharmaceutical industry.Proven track record of pursuing sales targets and driving revenue growth.Excellent communication, negotiation, and interpersonal skills.Strong analytical and strategic thinking abilities.Experience in in-licensing and out-licensing is highly desirable.Ability to work independently and as part of a team.Proficiency in Microsoft Office Suite and CRM software.Preferred Qualifications:Experience in supporting devices, formulations, and OTC products, with a great emphasis on devices.

Responsibilities:Key Functions:Responsible for regulatory strategy, submissions and approvals for new product registrations, renewals, variations, and maintenance of registered products.Responsible to maintain local SOPs and ensure compliance with regulations are met.Responsible for providing input and approval on advertising/promotional materials for regulatory compliance.Provide support to commercial team from regulatory perspectives.Poison License Holder, company pharmacist.Primary contact with Regulatory Authority Department in the country.Regulatory :Product scope includes new molecules, generics, biosimilars, medical devices, diagnostics and OTC.Lead local regulatory work for pharma division including new product/ device registrations, variations and renewals.Conduct regulatory related submission/ correspondence with respective local health authorities (National Pharmaceutical Regulatory Agency NPRA and Medical Device Authority MDA).Develop registration strategies, implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives. Review, analyze and coordinate data for new product submissions, line extensions according to priorities. Ensure up-to-date product registration, variation, line extension and other related law & regulations knowledge.Ensure that the content complies with government regulations prior to submission to Regulatory Authority.Maintain an awareness of country’s regulatory legislation and assess its impact on company’s business.Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.Maintenance of regulatory related database and licences such as product technical files, product complaints and adverse drug reaction records, import and poison A licences, etc.Local SOPs and Policies :Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with NPRA and MDA requirements.Lead applicable regulations and standards including cGMP and Safety; Compliance topics and quality systems such as GDP, Change Control, Data Integrity, auditing, and Complaint Handling. Support Marketing Activities :Conduct strategy meetings with commercial team to discuss product pipelines and registration plans.Provide management with a monthly registration status.Provide regulatory input and support for marketing plans, product launches and other cross- functional activities.Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.Pharmacovigilance (PV) and Quality Assurance (QA) Support :Lead local pharmacovigilance system in line with local regulatory requirements. Drive maintenance and preparation of local quality management system and internal audit in compliance to local regulatory requirements,Requirements:Qualifications :Bachelor’s degree in pharmacy.Registered pharmacist recognized by MOH Malaysia.Experience in regulatory affairs in a pharmaceutical or medical device company.Familiar with local regulatory bodies such as NPRA and MDA.Strong initiative and ability to take lead on projects.

Responsibilities:The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging.Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues.Communicates to multiple departments and supervision to provide timely process and issue updates.Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams.Participates in reviews and structured processes for continuous improvement.  Quality Operations:Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.Becomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging.Follows internal processes related to controlled substances.Performs GMP related verifications such as line clearances, cleaning, room inspection, and materialsCollects and appropriately labels packaging retain samples, and submits to the archive storageMay execute computer data entries in CME, JDE, LIMS, and/or department databases.Collects retain samples and performs sample evaluation for Annual Product Review.May backup third party product review/release.Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components for release testing.Non-conforming events:Responds to and escalates events identified during production to Quality Management.Participates in investigations with the Rapid Response Team as needed.Process Improvement:Collaborates with Manufacturing and Quality partners to identify and implement improvements.Compliance:Conducts GMP walkthroughs of facilitiesLearns how to perform in-process audits to identify adherence to SOPs and BR requirements.Actively participates in training events, and maintains currency with assigned training requirements.Safety:Follows all procedures to ensure a safe and compliant work environment.Requirements:Education & Experience:High school diploma or equivalent with 2-4 years of relevant industry experience (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)Ability to communicate and work with teams.Attention to detail.Strong documentation skills.Ability to read and interpret SOPs and function within the scope of procedures.

Role Description:The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances.Those matters include licenses, procurement, and movement of material, production, shipment and destruction.Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.Responsibilities:DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at siteReviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)Maintains Know your Customer (KYC) informationConducts year‐end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA websiteCoordinates all movement of controlled substances from manufacturing through analytical testingLiaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperworkMaintains compliance of all DEA, State, and Board of Pharmacy registrationsCoordinates all controlled substance destruction with QC, Environmental, Health & Safety and Logistic departmentsWorks with Security department to maintain facility upgrades to security systemsPower of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 formsResponsible for submitting CII quota applications to DEA; maintain organized DEA files on related activitiesCoordinates and documents DEA audits for sites and issues audit reports to management upon completionRemains current on DEA regs in order to address organization business needsCreates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.SOPs:Updates associated SOP’s related to job functionsSupporting responsibilities: Back up to State Licensing associateParticipates and represents department at project meetings as requiredRequirements:Education & Experience:Bachelor’s degree in a relevant field required2+ years’ relevant work experienceExperience with IQVIA SOM software preferredWorking knowledge of GMP regulations and compliance issuesStrong knowledge of DEA and FDA regulationsKnowledgeable of production and production planning processes

Responsibilities:Oversee physical/chemical/microbiological testing and analyses of pharmaceutical raw materials, excipients and finished drug products, including release, stability testing, cleaning verification test, and in-process testing.Supervise daily work of Chemists, Microbiologists and Technicians; provide guidance and directions when necessary. Conduct lab investigations and prepare deviations as needed.  Testing:Execute work schedule, review analysts’ notebooks and supervise analysts in day-to-day operations to ensure the compliance of SOP, cGMP, GLP, DEA regulations and/or MSDS.Understand analytical instrument operation/maint. of HPLC, UV-Vis, FT-IR, GC, dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Expert in analytical instrumentation to assure quality of test results.Review notebooks and instrument logbooks. Release test results to QA or other departments in a timely manner.Ensure timely completion of stability testing, provide data to regulatory groups, and conduct data trending during product shelf life.Perform methods development, transfer, verification and validation activities. Coordinate and assist with evaluation of Process Validations studies.   Documentation Practice, Training and Compliance:Ensure work of staff is in compliance with good documentation practices per company's SOP and cGMP regulations in the laboratory.  Prepare and review laboratory documents such as Laboratory Deviations, Investigations, and Test Methods in a timely manner.Enforce all applicable safety and standards guidelines, DEA regs and/or MSDS in lab. Ensure analysts are trained properly before they conduct corresponding testing.Lab Maintenance:Perform housekeeping on regular basis. Oversee general lab support; sample receiving, chemical inventory and document filing.Enforce safety by ensuring wearing of lab coat, safety shoes, safety glasses while in lab.Monitor ordering of lab supplies.Enforce the control and management of controlled substances.  Staff Development: Evaluate potential candidates for QC; prepare annual performance evals. for chemists.   Prepare chemists and laboratory for FDA and other compliance audits.Ensures adequate resources are trained to support compliance and business initiatives.Requirements:Education & Experience:BS in chemistry, biochemistry, pharmacy, or related discipline. Advanced degree a plus.7+ years of experience in pharmaceutical laboratory.2+ year QC supervisory experience preferred.Knowledge:Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.Proficiency required with laboratory techniques/instruments, such as pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, HPLC or GC and analytical balance, etc.Skills & Abilities:Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; open to other ideas and tries new things.Planning/Organizing – Prioritizes/plans work; uses time efficiently; plans for additional resources; sets goals/objectives; organizes/schedules other people and tasks; develops realistic action plans.Safety and Security - Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.Good verbal and written communications with basic computer skills.Physical Requirements:Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some bus. travel. Work is performed in a FDA and DEA-regulated pharmaceutical lab environment with risk of exposure to various chemicals.Must occasionally lift and/or move up to 25 pounds. Lab coat and safety glasses required in work environment. Specific visions abilities are required by this job include close vision and color vision.The noise level in the work environment is usually moderate. The work environment is representative of a group laboratory environment. 

Responsibilities:Articulate a clear vision for the business unit based on company objectives. Responsible to define the strategy of BU based on market opportunities, customer needs and therapeutic franchise goals. Deliver BU objectives and build a solid Annual Brand Plans, including revenue growth and financial target, commercial execution, profitability, expense control, process optimization, productivity, employee development, and customer satisfaction.Collaborate with the Commercial Excellence team for forecasting & analytics to develop appropriate forecasts to drive commercial success and accuracy.Improving result by monitoring key operational metrics, measurements, and targets.Develop strategy to manage and engage Key Opinion Leaders and key customers of our products, maintenance strong relationship with them. Provide leadership and support to team, establish and lead high-performance team which includes talent identification, development plans and succession plans.Requirements:Ensure compliance with appropriate SOP’s, policies and guidelines.Preferable someone with close engagement with multi medical association including internal medicines, gastrohepatologist, endocrinologist, cardiologist, neurologist, obstetric and gynaecologist, and surgeon. Possesses strong understanding of market and sales strategy. Track record in defining, planning and shaping strategies and initiatives that set direction for business unit and/or function.Proven successful track records in achieving sales target with entrepreneurial mindset.Experience involving managing financial performance, P&L responsibilities.Experience with significant people demands, track record of attracting & developing talent, developing bench strengths and managing complex, diverse and remote workforce (People Management & development of team)Client Interface.Desired Experience and Education:University Degree with Science education ( eg: pharmacy, medicine ). MBA is advantage. A minimum 15 years successful sales and marketing experience in pharmaceutical, healthcare, medical devices both sales and marketing with mixed local pharmaceutical and global pharmaceutical experiences. At least 8 year must be in managerial position. Extensive experience in portfolio of Cardiovascular & Metabolic, or Gastrointestinal, or Ob&Gyn or Respiratory, or Neuroscience or Paediatric or Medical Device.Key Working Relationships:Local and International KOLsMain National & Regional stakeholdersMedical societies and patient associationsInternal stakeholders incl. Medical Affairs, RA, Patient Access, Commercial Excellence & HQ team

Skills

Industry

Location

Jobtitle

16 pharmaceutical Jobs found

Business Unit Head (OTC)

Business Unit Head - Pharma & Medical Device

Customer Service Assistant Manager

Regulatory Affairs Professional (Product Regulatory Expert)

Business Development Lead (Global Role)

Regulatory Affairs Manager

Associate I, Quality Operations

Specialist, DEA Compliance

QC Supervisor

BU Manager/ Head - CVM, Gastro, Women Health & Medical device

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

16 pharmaceutical Jobs found

Business Unit Head (OTC)

Business Unit Head - Pharma & Medical Device

Customer Service Assistant Manager

Regulatory Affairs Professional (Product Regulatory Expert)

Business Development Lead (Global Role)

Regulatory Affairs Manager

Associate I, Quality Operations

Specialist, DEA Compliance

QC Supervisor

BU Manager/ Head - CVM, Gastro, Women Health & Medical device

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.