2. Regulatory and Profession Support/ Advice (Weights: 36%)
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.
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.
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.
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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