"Latest Hiring Apotex Regulatory Affairs in Mumbai, Maharashtra 2025-26 Apply Now"
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(Apotex Hiring Regulatory Affairs Executive in Mumbai Jobs 2025-26) |
If you’re passionate about pharmaceutical regulatory affairs and want to build a strong global career, here’s a great opportunity for you. Apotex, one of the world’s leading research-driven pharmaceutical companies based in Canada, is hiring for the position of Regulatory Affairs Executive in Mumbai. This role offers a chance to work on international regulatory submissions, product life-cycle management, and compliance tasks across major global markets.
For professionals with experience in regulatory submissions, post-approval changes, and variation filings, this opening can be a perfect opportunity to step into a global regulatory environment and advance your pharma career.
About Apotex:-
Apotex is a well-known global pharmaceutical company that manufactures high-quality generic medicines used by millions worldwide. With operations across Canada, the United States, Europe, Australia-New Zealand, and other ROW markets, the company focuses on improving global access to affordable medicines. Apotex is recognized for innovation, compliance, quality, and a collaborative workplace culture.
Job Overview: Regulatory Affairs Executive – Mumbai:-
The Regulatory Affairs Executive will be responsible for supporting global post-approval regulatory submissions, ensuring compliance across multiple regulated markets like the US, Canada, EU, UK, Australia-New Zealand, and other international regions.
This role requires strong knowledge of regulatory guidelines, documentation, and product life-cycle management (PLCM).
Key Responsibilities:-
As a part of the Global Regulatory Affairs team, your responsibilities will include:
1. Handling Global Post-Approval Submissions:
Prepare, review, and submit regulatory variations and post-approval updates for major markets.
Support change control assessments and ensure regulatory compliance for each product.
2. PLCM Documentation & Compliance:
Compile regulatory product life-cycle management documents.
Ensure timely submissions according to market-specific guidelines.
3. Database & Tracker Management:
Maintain and update regulatory databases, trackers, and documentation systems.
Coordinate with internal teams and suppliers to gather required data.
4. Deficiency Response Support:
Draft and review responses to regulatory deficiencies or queries received from health authorities.
Work with third-party manufacturers and internal functional teams to provide accurate information.
5. Cross-functional Collaboration:
Work closely with QA, QC, R&D, and Supply Chain teams.
Communicate clearly with external stakeholders, agents, and partners to ensure complete and accurate submission data.
6. Adherence to SOPs:
Ensure all activities follow regulatory SOPs, compliance requirements, and global quality standards.
Required Qualifications & Skills:-
To be eligible for this position, candidates must have:
Educational Background:
Graduate or Post-Graduate degree in Pharmacy, Chemistry, or Life Sciences. Candidates Apply Now.
Experience:
Minimum 3 years of experience in regulatory affairs.
Strong exposure to post-approval submissions for the US, Canada, EU, UK, Australia-New Zealand, and ROW markets.
Technical Skills:
Understanding of global regulatory guidelines and submission requirements.
Ability to prepare, review, and compile variation and PLCM packages.
Familiarity with regulatory databases and compliance systems.
Soft Skills:
Good communication and analytical skills.
Ability to work in cross-functional teams.
Detail-oriented, self-driven, and proactive in problem-solving.
Why Work at Apotex? (Benefits & Work Culture):-
Working with Apotex brings several advantages:
Competitive salary and employee benefits.
Exposure to global regulatory processes and advanced documentation systems.
Supportive and collaborative work environment.
Opportunities for professional learning and international market experience.
Work on pharmaceutical products that improve health outcomes worldwide.
Apotex promotes diversity, inclusion, and equal opportunities. The company also provides support and accommodations for applicants with special needs during the recruitment process.
How to Apply?
Interested candidates can apply through the official Apotex career portal.
Submit your updated resume and fill out the application form.
Apply Now:
https://careers.apotex.com/job/Mumbai-Executive%2C-Global-Regulatory-Affairs-MH-400079/597668817
Applications are reviewed on a rolling basis, so candidates are encouraged to apply as early as possible.
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