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.