Apotex Hiring Executive – Global Regulatory Affairs

B.Pharm/M.Sc Executive – Global RA | 3+ Yrs | Mumbai

Apotex hiring Executive – Global Regulatory Affairs in Mumbai. Requires 3+ yrs experience with US/CAN/EU/AUS-NZ submissions.

Apotex is hiring an experienced professional for the Global Regulatory Affairs (GRA) team in Mumbai. This role supports regulatory life-cycle management, post-approval submissions, and compliance activities for US and Canadian markets. Candidates with strong understanding of PLCM submissions and global regulatory frameworks will find this a high-impact opportunity within a global pharmaceutical organization.

Company Overview

Apotex Inc. is a leading Canadian-based global health company known for its diverse portfolio of generic medicines, biosimilars, innovative formulations, and consumer health products. Headquartered in Toronto with operations across the United States, Mexico, India, and other regions, Apotex remains one of the largest pharmaceutical contributors in North America.

The company focuses on improving access to affordable healthcare while maintaining high-quality standards and regulatory integrity. Its Mumbai facility plays a major role in global regulatory operations, product life-cycle management, and compliance support for international markets.

Job Role & Responsibilities

• Prepare and review quality regulatory PLCM submissions for US and Canada.
• Maintain regulatory documentation and approved-product databases.
• Coordinate and compile regulatory submissions, deficiency responses, and post-approval supplements.
• Assess change control documents and provide regulatory impact evaluation.
• Maintain trackers including PLCM checklists, deficiency logs, and submission spreadsheets.
• Collaborate with cross-functional teams to resolve regulatory information gaps.
• Coordinate with third-party manufacturers for document requirements.
• Act as a back-up for team members and support assigned regulatory activities.
• Ensure compliance with SOPs, regulatory guidelines, and Apotex policies.
• Participate in drafting and reviewing SOPs and regulatory guidelines.
• Communicate with external partners, agents, and suppliers for required regulatory data.
• Demonstrate Apotex values: Integrity, Teamwork, Courage, Innovation.
• Comply with ethics, quality, safety, environment, and HR policies.
• Perform additional duties as assigned by management.

Eligibility / Qualifications

• Education: Graduate or Post-graduate degree in Chemistry, Pharmacy, or Life Sciences.
• Experience: Minimum 3 years experience in regulatory submissions for US/CAN/EU/AUS-NZ.
• Strong knowledge of post-approval change submissions and variation package compilation.
• Understanding of global regulatory guidelines, PLCM, change control, and compliance.
• Ability to manage multiple regulatory projects with accuracy.

Relevant Courses: B.Pharm, M.Pharm (Regulatory Affairs/Pharmaceutics), M.Sc Chemistry, M.Sc Life Sciences, PG Diploma in Regulatory Affairs.

Location & Salary

• Location: Mumbai, Maharashtra – 400079
• Salary: Competitive (based on experience and internal structure)

Application Process

Apply directly using the official link:
🔗 https://careers.apotex.com/job/Mumbai-Executive%2C-Global-Regulatory-Affairs-MH-400079/597596717/

FAQs

Is experience in US/CAN submissions mandatory?
Yes. This role specifically requires hands-on PLCM and variation submission experience for regulated markets.

Are freshers eligible?
No. Minimum 3 years regulatory experience is required.

Does the role involve cross-functional interaction?
Yes. The position requires coordination with QA, QC, Manufacturing, and external partners.

Are accommodations provided for applicants with disabilities?
Yes. Apotex offers accessibility support throughout the recruitment process.

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