Regulatory Affairs Manager

Director of Product Management

Business Development Lead (Global Role)

Specialist, DEA Compliance

Downstream Business Development Lead

Responsibilities: <ul><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices/pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li><li>Responsible to get the necessary documents which are going to be useful for registration purpose.</li><li>Usually, this registration application is done online, and you need to constantly keep a follow up with the regulatory team.</li><li>Responsible to liaise with the authority daily based on the requirements pertaining to document for the smooth transition with the regulator and submit regularly to the regulating authority to get the registration executed in a timely manner.</li><li>Front lining the entire process with respect to coordination with Originator, regulatory authority and in need be travel to Delhi for meetings.</li><li>The company has tied up with an agency to make sure there are no gaps and you will be responsible to liaise with the Agency who closely work with the government authority to satisfy the documentation requirements.</li><li>You will be also responsible to regularly interact and funnel the requirements with the agencies and the regulatory authorities.</li><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices/pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li></ul> Requirements: ﻿Skills and Qualifications <ul><li>Bachelors degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering.</li><li>Advanced degree (e.g., MBA, MS, or Ph.D.) is an advantage.</li><li>Strong knowledge of regulatory requirements (CDSCO, FDA, EMA, MHRA, TGA, etc.) and global standards (ISO, ICH, etc.).</li><li>Excellent project management and organizational skills.</li><li>Ability to analyze and interpret complex regulations.</li><li>Proficient in regulatory writing and submission tools.</li><li>Strong communication and interpersonal skills.</li><li>Ability to manage multiple projects and meet deadlines.</li></ul> Experience <ul><li>7–8 years of experience in regulatory affairs, with a proven track record of successful submissions and approvals.</li><li>Experience in handling registration of Medical Devices and getting approval.</li></ul>

Overview: <ul><li>will be responsible for building, leading, and managing a complex global high speed interconnect product portfolio, including developing the strategy and business plan, driving new product development, gaining cross functional alignment and driving the execution of the business plan.&nbsp;</li><li>This individual will also be responsible for managing a team of global product managers located around the globe.&nbsp;</li><li>will be a growth driven, commercially savvy executive who will own the key product strategies and execution for a growing global business.&nbsp;</li><li>The Director, Product Management is responsible for the long-term vision of the product families and will have responsibility for overall product strategy and business leadership, and meeting sales, profit, and other financial goals.&nbsp;&nbsp;</li><li>will manage all aspects of a global product line portfolio, from driving new product development to defining the go-to-market strategies and product roadmap in liaison with Sales and Marketing. </li><li>He/She must collaborate with Engineering and Operations to ensure that the strategy, development and manufacturing capability &amp; capacity are in place to achieve defined business targets at the right cost, schedule and quality. In addition, he/she will also be responsible for defining and leading growth through licensing and partnership opportunities.&nbsp;</li><li>will need to act with an entrepreneurial spirit and manage the portfolio with a GM mindset. This role requires strong strategic thinking and experience working across regions. Experience dealing with Cloud Service Providers and GPU companies is a major plus. The Director, Product Management will bring a culture of customer obsession and work cross functional to improve TE response times</li></ul> Responsibilities: <ul><li>Market Sensing &amp; Strategy Development</li><li>Articulate market and industry trends, demand drivers, customer needs, and competitive landscape</li><li>Conduct market segmentation exercises to develop market segment-specific strategies&nbsp;</li><li>Conduct and/or lead team in competitive analysis and benchmarking&nbsp;</li><li>Define segment-specific value propositions that beat the competition&nbsp;</li><li>Develop long term product roadmaps that align with business strategy&nbsp;</li><li>Design go-to-market strategy, inclusive of channel strategy and licensing partnerships&nbsp;</li><li>Work with R&amp;D and operations in the development of new products to meet current and future customer requirements&nbsp;</li><li>Manage product lifecycle Develop Business Plan&nbsp;</li><li>Define resource requirements necessary to execute the product roadmap&nbsp;</li><li>Work cross functionally to define sales, technology and operations strategies and goals, in line with financial goals&nbsp;</li><li>Build consensus on specific tasks Establish pricing policy&nbsp;</li><li>Develop the annual operating plan (sales and gross or standard margin)&nbsp;</li><li>Engage with customers to better understand their needs and ensure our product plans are aligned to their strategic priorities Execution – New Product Development &amp; Launch&nbsp;</li><li>Be the opportunity champion for new growth projects and/or assist team in opportunity assessment&nbsp;</li><li>Plan product launches, including the development of marketing and sales plans&nbsp;</li><li>Ensure team provides intelligent demand forecast inputs to S&amp;OP&nbsp;</li><li>Negotiate directly with customers on large program opportunities&nbsp;</li><li>Exercise thought leadership for the interconnect and cable ecosystem market&nbsp;</li><li>Provide inputs to Marcom for the development of collateral, including e-commerce Execution – Post Launch Product Management&nbsp;</li><li>Manage the P&amp;L (sales and gross or standard margin) for the assigned portfolio&nbsp;</li><li>Deliver sustained, profitable growth&nbsp;</li><li>Enable sales to promote product line via training and the development of collateral materials that help articulate the value proposition&nbsp;</li><li>Manage special price requests&nbsp;</li><li>Track progress to the business plan and facilitate resolution to gaps&nbsp;</li><li>Be the champion for resolution of product issues (e.g., quality, delivery, etc.) Talent Management&nbsp;</li><li>Manage, energize, and motivate a multi-cultural team of product managers located around the globe •</li><li>Build, coach and develop individuals and teams Key</li></ul> Requirements: <ul><li>The Director, Product Management will have a minimum of 5 years of product management experience with at least 10 years in B2B commercial roles.&nbsp;</li><li>He/She must have proven success leading strategic growth initiatives and product management engagements in engineering and manufacturing driven industries.&nbsp;</li><li>The successful candidate must possess proven strategic, analytical and implementation skills.&nbsp;</li><li>Understanding of Cloud/Datacenter hardware architectures&nbsp;</li><li>Experience with high speed interconnects a major plus – twinax cabling, near chip connectivity, high speed IO or similar products 4-year technical or business degree required&nbsp;</li><li>Advanced degree (MBA) and relevant P&amp;L management experience preferred&nbsp;</li><li>Ability to support travel of approximately 10-25% (both regional and global)&nbsp;</li><li>Strong business acumen with an ability to understand technically complex concepts&nbsp;</li><li>Experience negotiating high stakes and large dollar value contracts&nbsp;</li><li>Creative and innovative thinker able to provide input on the development of the product strategies and the relevant business plans with the ability to execute&nbsp;</li><li>Proven ability to multi-task and drive results in a dynamic, high paced environment</li><li>Strong interpersonal, planning, organization, and teamwork skills&nbsp;</li><li>Experienced leader with an ability to influence cross functional teams and to build strong relationships both internally and externally&nbsp;</li><li>Advanced presentation skills with the ability to effectively communicate complex concepts to foster understanding and acknowledgement of critical information both up and down the organization</li></ul>

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.

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:Support Business Development Specialist/Consultant on business development process from market analysis, screening and evaluation of opportunities including strategic fit assessments, developing key business principles, managing due diligence execution, performing risk assessments, developing and negotiating term sheets and definitive transaction agreements through to transaction closure and integration planning. Progress opportunities and transactions through the company’s defined stage-gates, and prioritize investment proposals against internal investment criteria and corporate strategies.Support downstream business development activities including: (i) creating and developing partnerships along the downstream value chain in refining, petrochemicals, marketing including wholesale & retail, logistics and storage; (ii) developing business proposals; (iii) identifying risks with mitigation plans; and (iv) identifying suitable partnership strategies and business models to maximize value creation for the company. Support business portfolio optimization and identify synergies between assets and affiliates; manage development and negotiations of commercial agreements; provide administrative direction to junior Business Development Analysts in reviewing legal documents which include head of terms, memorandums of understanding (MoU), letters of intent (LoI), cost sharing agreements, joint venture agreements, shareholder agreements, share purchase agreements, feedstock supply agreements, product supply and offtake agreements. Additionally, pursue opportunities for product marketing and technology licensing, as applicable.Participate in developing techno-economic analysis, financial analysis and valuations of target assets including familiarity with the different valuation methodologies (discounted cash flow (DCF), trading multiples and precedent transactions). Develop negotiation and transaction/project execution strategies.Utilize available market data to develop market and sector analysis, and competitive landscape assessments as part of proactive origination of opportunities.Prepare management briefings, board papers and presentations.Requirements:Bachelor’s degree in Engineering (Chemical preferable, or other disciplines), Business, Finance or Economics. MBA or a relevant advanced degree is strongly preferred. Professional Certifications (preferred): Project Management Professional (PMP), Certified Financial Analyst (CFA) and Certified Management Accountant (CMA).Minimum of 9 years of professional experience in downstream business development, with a strong track record of technical, economic and commercial experience in downstream businesses such as refining, petrochemicals, marketing (wholesale & retail), lubricant, logistics and storage, with a deep understanding of associated operations, optimization and value-chain integration.Excellent communication skills both verbal and written, and demonstrated experience navigating and influencing complex internal stakeholder groups and negotiating with prospective partners and service providers to ensure successful business outcomes for the company.Good grasp of international business and cross-cultural professional practices.Demonstrated experience in executing term sheets and definitive agreements typical in downstream transactions, along with management of post-transaction integrations, setup and readiness.

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5 in licensing Jobs found

Regulatory Affairs Manager

Director of Product Management

Business Development Lead (Global Role)

Specialist, DEA Compliance

Downstream Business Development Lead

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5 in licensing Jobs found

Regulatory Affairs Manager

Director of Product Management

Business Development Lead (Global Role)

Specialist, DEA Compliance

Downstream Business Development Lead

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

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COMPANY

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