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Pfizer Regulatory Affairs Manager in Bangkok, Thailand

JOB SUMMARY

Senior Regulatory Affairs Manager/ Regulatory Affairs Manager supports Regulatory Affairs Team Lead Thailand , as assigned, to manage all activities pertaining to product registration and other regulatory approvals, including registration plans and submission strategies, product advertising, drug reports, and company license renewals. He/she arranges packaging artworks of registered products and ensures all activities under responsibility comply with relevant regulations and company SOPs. The Senior Regulatory Affairs Manager / Regulatory Affairs Manager also provides regulatory advice and regulatory information to relevant colleagues, and manages regulatory matters as assigned. He/she also represents the company position on regulatory affairs-related matter in dealing with the regulatory authorities concerned.

Principal working relationships with local regulatory authorities, relevant above-country functions, manufacturing sites, local contract manufacturers, local distributor, local hospital customers and relevant local staff - Medical, Marketing, Sales, Logistics, Legal and Business Technology.

JOB RESPONSIBILITIES

1. Product Registration

Submission-Approval of Plan and Strategy

  • Supports Regulatory Affairs Team Lead in generating and regulatory updating submission-approval plan and strategy to support the marketing launch plan

  • Manage all activities pertaining to product registration and other regulatory approvals; including registration plans and submission strategies, product advertising, drug reports, and company license renewals

Regulatory Approval

  • Prepares, submits, coordinates, and follows up on product registration concerned to ensure timely approval according to product registration plan

  • Handles any amendments to registered products under his/her responsibility

  • Handles product advertising applications concerned for regulatory approval by coordinating with Marketing Department

Packaging Artwork Development: Arranges and updates artworks of packaging materials of registered products concerned by coordinating with Logistics, Marketing and product suppliers

  1. Regulatory and Profession Support/ Advice

Regulatory Issues: Works closely with local product team, Public Affairs, Legal, Above Country RA support team, as necessary, to set up and implement appropriate action plans related to regulatory issues Supports and provides professional comments, recommendations, and information to overseas and local parties (both internal and external) Develop professional relationship with TFDA staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations Keep abreast of changes in the regulatory environment to assure accuracy and effectiveness in regulatory submissions.

  1. Standard Operating Procedures

Local Labeling: Arranges and updates Local Product Document (LPD)/ Local Language Document (LLD)/ Patient Information Leaflet (PIL) to ensure their conformity with the Core Data Sheet (CDS), and compliance with relevant SOPs. PEARL (Product Events and Registration Licenses) : Ensures maintenance of relevant product registration information in PEARL according to relevant SOP. Keeps the Safety team informed of adverse events according to relevant SOPs. Ensures compliance with other relevant company SOPs Product Advertising and Promotional Material: Provides regulatory comments/advice to Marketing and Public Affairs as assigned in developing promotional materials and product advertising activities according to relevant SOPs.

4. Functional Administration

Handles correspondence with overseas and local parties (both internal and external) in order to obtain or supply required information/documents. Maintains relevant registration licenses, regulatory affairs-related information/system, correspondence, and other relevant documentation for easy retrieval. Ensures hat they are kept current, correct and confidential. Maintains product registration information in TRUST (Thailand Regulatory Utility System) Supervises, coaches and supports junior staff as assigned, allocates job and supports trainings required for effective operations to meet goals and objectives.

5. Company's Regulatory Compliance

Monitors and manages regulatory-related activities concerned and provides recommendations to relevant parties for their compliance with regulations. Manages the relevant regulatory drug reports and ensures that they are maintained and/or submitted in a timely manner to the regulatory authorities in accordance with relevant regulations Manages RA activities on commercial release of imported products concerned to ensure that their packaging, product appearance and finished product specification comply with the regulatory approval. Keeps abreast of regulatory changes and keeps the Thailand Regulatory Affairs Team Lead and other colleagues concerned informed of these changes in order to ensure Company's alignment with those changes. Manages and ensures timely renewal of company licenses as assigned

  1. External Networking

  2. Regulatory Affairs Reports

Qualifications

Education:

Bachelor of Science in Pharmacy

Experience:

  • 10 years experience in Regulatory Affairs

#LI-PFE

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

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