Regulatory Affairs Manager

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.