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Assistant Manager Regulatory Affairs

3.00 to 6.00 Years   Chennai   07 Apr, 2020
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

  • 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 Pfizers 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 Pfizers internal procedures and training SOPs i.e P2L and PCEC.
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Keyskills :
spa sops rackwise listing epalms gdms affairs regulatory drug pdm

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