Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc.
Post : Senior Executive, Regulatory Affairs - API
Job Description
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
Candidate Profile
• 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.
• 6-8 years’ experience in Regulatory Affairs
Additional Information
Qualification : M.Pharm, MSc
Experience : 6-8 years
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs - API
End Date : 30th October 2024
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