Regulatory Sciences Manager

4 days ago

Hanoi, Vietnam Pfizer Full time

Regulatory Science Manager supports the Head of Regulatory Science, as assigned, to manage all activities pertaining to product registration and other regulatory approvals, including registration plans and submission strategies, local COA for registration (applicable for vaccines), product advertising, drug reports for portfolio in charge including vaccines; chemicals and/or biologics. He/she arranges packaging artworks of registered products and ensures all activities under responsibility comply with relevant regulations and company SOPs. The Regulatory Science 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 science-related matter in dealing with the regulatory authorities concerned.

Build good working relationships with local regulatory authorities (NICVB, DAV, CPC, ), relevant above-country functions, manufacturing sites, local contract manufacturers, local distributor/distributors in Vietnam and relevant local staff - Medical, Marketing, Sales, Supply Chain, Legal, Public Affairs, SCQ.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

1. Product Registration

Submission-Approval of Plan and Strategy
- Supports the Head of Regulatory Science in generating and regulatory updating submission-approval plan and strategy to support the marketing launch plan
- Regulatory Approval
- Prepares, submits, coordinates, and follows up on product registration dossiers and local COA (for vaccines) to ensure timely approval according to product registration plan
- Handles any amendments to registered products under his/her responsibility
- Packaging Artwork Development: Arranges and updates artworks of packaging materials of registered products concerned by coordinating with Logistics, Marketing and product suppliers

2. Regulatory and Profession Support/ Advice

Regulatory Issues: Works closely with local product team, Public Affairs, Legal, GRL, RRHS, 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) Maintains awareness of competitor intelligence, as well as changes in relevant law, regulations, and requirements, in order to keep other relevant colleagues informed.

3. Standard Operating Procedures (SOP’s)

Local Labeling: Arranges and updates Local Product Document (LPD)/ Local Language Document (LLD) to ensure their conformity with the Core Data Sheet (CDS)/reference sources, and compliance with relevant SOPs. Product Advertising and Promotional Material: Provides regulatory comments/advice to Marketing colleague as assigned in developing promotional materials and product advertising activities according to relevant SOPs. PEARL: Ensures maintenance of relevant product registration information in PEARL according to relevant SOP. Ensures compliance with other relevant company SOPs and systems

4. Functional Administration

4.1 Handles correspondence with overseas and local parties (both internal and external) in order to obtain or supply required information/documents.

4.2 Maintains relevant registration licenses, regulatory Science-related information/system, correspondence, and other relevant documentation for easy retrieval. Ensures that they are kept current, correct and confidential.

4.3 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 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 Head of Regulatory Science and other colleagues concerned informed of these changes in order to ensure Company’s alignment with those changes.

6. External Networking

6.1 Maintains and enhances partnership with regulatory Science-related organization and relevant industry associations toshare information/knowledge and help shape a better health care environment

7. Regulatory Science Reports

Supports the Head of Regulatory Science in the timely preparation of reports, such as the Monthly Report.

Work Location Assignment: Flexible

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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