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Regulatory Affairs Executive

Pfizer


Location:
Khwaeng Lumphini, Krung Thep Maha Nakhon 10330
Date:
12/23/2017
2017-12-232018-01-23
Pfizer
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Job Details

**1. Product Registration** (Weights: 38%)



1.1 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 Manager







1.2 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** (Weights: 36%)



2.1 Provides professional comments, recommendations, and information on relevant regulations to local colleagues (both internal and external)



2.2 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.







**3. Standard Operating Procedures (SOP's) (** Weights: 10%)



3.1 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.



3.2 Global Regulatory System (GRS): Ensures maintenance of relevant product registration information in GRS according to relevant SOP.



3.3 Keeps the Safety team informed of adverse events according to relevant SOPs.



3.4 Ensures compliance with other relevant company 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 TIRAS (Thailand & Indochina Regulatory Affairs 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.







**6. Regulatory Affairs Reports** (Weights: 1%)



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.
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