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Apotex, through its affiliate ApoPharma, is inviting applications for the Trainee – GBS GRA PLCM position in Mumbai, Maharashtra. This entry-level role is ideal for B.Pharm and M.Pharm graduates looking to build a strong foundation in global regulatory affairs, particularly in dossier compilation, product lifecycle management (PLCM), and tender submissions.
This opportunity provides hands-on exposure to regulatory documentation, global submission processes, and collaboration with cross-functional teams, all within a leading global pharmaceutical organization.
Key Responsibilities
As a Regulatory Affairs Trainee at Apotex, you will:
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- Collate, compile, and submit regulatory documentation for assigned projects.
- Coordinate tender submissions and update regulatory databases.
- Communicate with affiliates, customers, and health authorities regarding submissions.
- Maintain accurate regulatory records, trackers, and status reports.
- Respond to queries from internal teams and regulatory agencies.
- Act as a backup for team members and support additional projects when needed.
- Complete assigned training on time and adhere to all compliance programs.
- Promote a collaborative, safe, and ethical work environment aligned with company values.
Qualifications & Skills
Education:
- Graduate or Postgraduate in Pharmacy (B.Pharm/M.Pharm).
Preferred Skills:
- Strong academic background.
- Knowledge of new product dossier preparation and PLCM submission requirements is an advantage.
- Theoretical understanding of regulatory affairs for International/US-CAN-EU markets.
Why Join Apotex?
- Work with a global leader in generic and specialty pharmaceuticals.
- Gain practical exposure to regulatory submission processes.
- Be part of a supportive, inclusive, and ethical work culture.
- Opportunity to grow into senior regulatory roles over time.
Application Process
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