Assistant Manager- Regulatory Affairs

  • Company:
    Pfizer Inc.
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    1 week ago
  • Category:
    Biotechnology/Pharmaceutical/Medicine | Manufacturing/Industrial

Skill: ctd , regulatory; Exp: 0-3 years; Compilation and submission of Annual Reports (AR), including but not limited to i) Handling of AR change forms and review to ensure adequacy ii) Handling Pfizer’s tools such as PDM, GDMS, ePalms, SPA trackwise and PEARL for retrieval of changes and compilation. iii) Ensuring the SPL available in DailyMed is current before Annual Report submission, if any updates made during reporting period, the same can be requested to Drug Listing team to update SPL by providing current Labelling commodities. iv) Ensuring the availability of impacted CTD sections and relevant data (for eg., stability data Post AR submission activities i) Ensuring updation of 45.NDA ( as required) ii) Replacing stability sections in PDM. iii) Ensuring to share 356h form to shared folder if there is any updates during compilation. Resolution of issues. including timely communication of issues, impact and the outcomes to global regulatory management and core team. Complies with all standards, procedures and policies for submissions set forth for the Regulatory Function. Remains knowledgeable about current regulations and guidance to perform day to day regulatory activities. Ensures compliance to Pfizer’s internal procedures and training SOPs i.e P2L and PCEC. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Drug Regulation

Degree: 

Experience: 0-3

Function: Biotech / Pharma / R&D