Regulatory Affairs Executive Role at Apotex – Chemistry & Pharma Job in Mumbai – Apply Now!
Apotex, a leading global pharmaceutical company, is hiring a Regulatory Affairs Executive for Post-Approval Submissions at its Mumbai office. This is an ideal opportunity for pharma professionals with 3+ years of experience in regulatory documentation for US, Canada, EU, Australia–New Zealand, and ROW markets. If you’re skilled in lifecycle management, variation filing, and change control assessments, Apotex offers the perfect platform to advance your regulatory career.
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. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar, and specialty products.
Job Details:
Job Title: Executive, GRA PLCM
Location: Mumbai, MH, IN, 400079
Job Summary
Responsible for the product life-cycle management of Apotex products (Toronto) in identified markets. Maintenance of documentation/database records pertaining to approved products in line with systems, processes, and procedures. Leading and/or coordinating regulatory affairs projects, as assigned. Preparation of submission and
approval notifications for applications submitted to Regulatory agencies.Job Responsibilities
- Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.
- Responsible for the preparation and review of quality regulatory PLCM submissions for various markets to ensure timely approval.
- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
- Accountable for assessment, coordination, and compilation of deficiency responses in a timely manner.
- Works with other functional areas to resolve issues related to information for regulatory submissions.
Job Requirements
Education: A Post-graduate/Graduate degree in Chemistry/ Pharmacy.
Knowledge, Skills, and Abilities: Candidate should have knowledge about Post-approval change submission requirements and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets.
Experience: Candidate should have a minimum of 3 years of experience in US/CAN/EU/AUS-NZ/ROW markets.
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