Senior Executive, Reg Affairs-ARPL-RA AR

3 days ago

Bengaluru, Karnataka, India Apotex Inc. Full time ₹ 12,00,000 - ₹ 18,00,000 per year

About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: .

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

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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