Apotex Hiring Executive, GRA PLCM | 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, BSc, MSc in Life Sciences, Biotechnology, Microbiology, Biochemistry, Pharmacology, etc.)

Key Responsibilities

• 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.
• Evaluate, prepare and review of post-approval supplements to manage the regulatory product life-cycle as applicable.
• Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
• Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for PLCM/deficiency response, deficiency tracker, submission spreadsheet etc.) and ensure accuracy of information.
• Co-ordinate with third party manufacturers for document requirement for regulatory submissions.
• Act as a back-up for team members and support as & when required.
• Timely communication and follow-up with the respective departments for compilation and submission of PLCM submissions and query responses to meet agreed timeline.
• Interpret and ensure compliance with SOPs, RA policies & procedures and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable).
• Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and/or problems.
• Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

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