Apotex Hiring Executive, GRA PLCM (US-CA – Injectable) | Mumbai

Apotex Hiring Executive, GRA PLCM (US-CA – Injectable) | Mumbai

Are you an experienced regulatory affairs professional looking for a career opportunity in a global pharmaceutical company? Apotex Inc. is currently hiring for the role of Executive, GRA PLCM (US-CA – Injectable) at its Mumbai location. If you have expertise in regulatory affairs and lifecycle management, this role could be the perfect fit for you.

About Apotex Inc.

Apotex Inc. is a leading Canadian-based global pharmaceutical company dedicated to providing high-quality and affordable medicines across 75+ countries. With a strong presence in R&D, manufacturing, and commercial operations, Apotex focuses on the development of generic, biosimilar, and specialty pharmaceutical products.

Job Role: Executive, GRA PLCM (US-CA – Injectable)

Location: Mumbai, MH, India, 400079
Department: Regulatory Affairs
Experience Required: Minimum 3 years
Education Required: Postgraduate/Graduate degree in Chemistry, Pharmacy, or Life Sciences (including B.Pharm, M.Pharm, B.Sc, M.Sc in Life Sciences, Biotechnology, Microbiology, Biochemistry, Pharmacology, etc.)

Key Responsibilities

• Oversee the product life-cycle management (PLCM) for Apotex products (Toronto) in assigned markets.
• Prepare and submit regulatory applications and approval notifications to global regulatory agencies.
• Maintain accurate regulatory documentation and database records in compliance with company policies.
• Provide regulatory guidance and support to cross-functional teams to ensure compliance with global regulatory requirements.
• Evaluate, compile, and submit post-approval change applications for various markets (US, Canada, EU, Australia, NZ, and ROW).
• Assess and review change control documents, ensuring accurate evaluation of regulatory impact.
• Coordinate with third-party manufacturers for document requirements and regulatory submissions.
• Ensure compliance with SOPs, regulatory policies, and industry guidelines.
• Communicate with external stakeholders, including regulatory authorities, agents, and suppliers, to support submission processes.

Required Skills & Qualifications

• Strong understanding of post-approval change submissions and variation package compilation for US/CAN/EU/AUS-NZ/ROW markets.
• Hands-on experience in regulatory lifecycle management and compliance.
• Excellent documentation, communication, and analytical skills.
• Ability to coordinate with cross-functional teams and meet regulatory deadlines efficiently.

How to Apply

If you meet the qualifications and are ready to take the next step in your career, apply now!
🔗 Apply Here