Job Description

1. Product Registration (Weights: 35%)
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 other regulatory applications as assigned by the Regulatory Affairs Lead / Senior Regulatory Affairs Manager / Regulatory Affairs ManagerPackaging 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 (Weights: 35%)Provides professional comments, recommendations, and information on relevant regulations to local colleagues (both internal and external)Sales/ Marketing Activity Support: As assigned, optimally provides regulatory affairs-related advice/information and documents requested for hospital listing and bidding of Pfizer products to Sales/Marketing colleagues and hospital staff.Keeps abreast of changes in the regulatory environment to assure accuracy and effectiveness in regulatory submissions.
3. Standard Operating Procedures (SOP's) (Weights: 10%)
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 (Weights: 10%)
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 affairs-related information/ system, correspondence, and other relevant documentation for easy retrieval. Ensures that they are kept current, correct and confidential.
4.3 Maintains product registration information in TRUST (Thailand Regulatory Utility System).
5. Company's Regulatory Compliance (Weights: 5%)
5.1 Verified 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
5.2 As assigned, 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.
5.3 Checks certificates of analysis of imported products to ensure that their contents comply with the registered finished product specification. Keep RA colleagues concerned informed of the difference, if any.
5. External Networking (Weights: 3%)
5.1 Maintains and enhances partnership with regulatory affairs-related organization and relevant industry associations to share information/knowledge and help shape a better health care environment
6. Regulatory Affairs Reports (Weights: 2%)
6.1 Supports the Regulatory Affairs Lead/ Senior Regulatory Affairs Manager/Regulatory Affairs Manager in the timely preparation of reports, such as the Monthly Operating Report (MOR)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Save Job