Regulatory Affairs Jobs: Apotex Hiring an Executive | Apply Now
Looking to grow your career in one of the most trusted pharmaceutical companies? This Executive, Global Regulatory Affairs position at Apotex offers a remarkable opportunity for professionals seeking regulatory affairs jobs within a globally recognized organization. If you’re a life science graduate aiming for a high-impact life science job role in international markets like the US and Canada, this Apotex career opening delivers the perfect blend of challenge, stability, and growth.
Job Details
- Job Title: Executive, Global Regulatory Affairs
- Location: Mumbai, MH, IN, 400079
About the Company
Apotex Inc. is a Canadian-based global health company committed to improving everyday access to affordable and innovative medicines for millions of people worldwide. With a strong presence in the pharmaceutical industry, Apotex offers a diverse portfolio that includes generic medicines, biosimilars, innovative branded pharmaceuticals, and consumer health products.
Headquartered in Toronto, Apotex operates through regional offices in the United States, Mexico, India, and other global locations. As the largest Canadian-based pharmaceutical company, Apotex plays a key role as a preferred health partner across the Americas, particularly in pharmaceutical licensing and product acquisitions.
This strong global presence and dedication to patient-centric healthcare make Apotex an ideal organization for professionals exploring Apotex career opportunities—especially individuals passionate about regulatory affairs jobs and life science jobs in a highly impactful sector.
Key Responsibilities
- Preparation and review of regulatory PLCM submissions for US and Canada.
- Maintain regulatory documents to support compliance.
- Provide regulatory guidance to support teams.
- Assess and compile deficiency responses.
- Work with cross-functional teams for regulatory submission needs.
- Prepare and review post-approval supplements.
- Assess and review change control documents.
- Maintain regulatory databases and trackers.
- Coordinate with third-party manufacturers for documentation.
- Act as backup for team members when needed.
- Ensure timely communication and follow-ups for submissions.
- Interpret and comply with SOPs, RA policies, and guidelines.
- Communicate with external suppliers and agents.
- Work safely and exhibit company values: Integrity, Teamwork, Courage, Innovation.
- Follow all compliance programs, quality policies, safety protocols, and HR policies.
- Perform other assigned duties.
Educational Requirements
Post-graduate or Graduate degree in Life Sciences.
Experience
Minimum 3 years of experience in global regulatory markets.
Skills Required
- Strong knowledge of post-approval change submissions.
- Experience with variation packages for US/CAN/EU/AUS-NZ markets.
- Ability to coordinate regulatory submissions.
This role at Apotex offers a strong career pathway for individuals passionate about regulatory affairs jobs and eager to grow within a globally respected pharmaceutical organization. If you come from a life science background and aim to contribute to high-level regulatory processes, this Apotex career opportunity is an ideal step toward professional advancement.
