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PHARMA JOBS POST > API > Join Apotex: Senior Executive in Regulatory Affairs – API Role in Bangalore
APIBangalore

Join Apotex: Senior Executive in Regulatory Affairs – API Role in Bangalore

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Last updated: October 3, 2024 7:34 pm
ADMIN 8 months ago 59 Views
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Apotex is hiring for the position of Senior Executive, Regulatory Affairs – API at their Bangalore location. This role involves managing regulatory submissions and ensuring compliance with industry standards for Active Pharmaceutical Ingredients (APIs). Candidates with experience in regulatory affairs and a background in pharmaceuticals are preferred.

Contents
Senior Executive, Regulatory Affairs – APIJob SummaryJob ResponsibilitiesJob Requirements

Senior Executive, Regulatory Affairs – API

Location: Bangalore, KA, IN, 560099

Job Summary

Preparation of original DMF, amendments, Annual reports and Review of adequacy of documents for submission

Job Responsibilities

  • Compilation, review and submission of various Drug master files for US, EU, TGA, Canada and other markets as per respective regulatory guidelines and checklist
  • Preparation of Original Drug Master File for regulatory submission.
  • Preparation of Amendments and annual reports for regulatory submission.
  • Co-ordinate with technology transfer sites for RA support for DMF and dossiers.
  • Execution of regulatory activities through various tools like, Docubridge, Livelink, RIMS, Trackwise, label bridge etc.
  • Compilation of Deficiency responses for regulatory submission.
  • Review of draft RSM, MPDR and GTI discussion in-line to process and current requirements, and against the screening study data for DMF submission.
  • Change control assessment for regulatory impact before implementation.
  • Risk assessment of DMF’s from various API manufacturing to support in-house ANDA filing.
  • Supporting for Business development related activities (Third party customers)
  • Interacting with supporting departments like R&D, QC, QA, production and AR&D etc. on issues related to RA for DMF submissions and deficiency responses.
  • Administrative and local licensing activities involved in regulatory affairs.
  • All other relevant duties as assigned

Job Requirements

  • Education
    • Master’s degree in Science/Pharmacy
    • Knowledge, Skills and Abilities
    • Good command over MS-Office: Word, Power Point, Excel etc.
    • Interacting with supporting departments like R&D, QC, QA, production and AR&D etc. on issues related to RA for DMF submissions and deficiency responses.
  • Experience
    • 6-8 years’ experience in Regulatory Affairs

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally.

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