Global Regulatory Affairs Executive Job at Apotex
If you’re looking to grow your career in global regulatory affairs, Apotex is offering an exciting opportunity in Mumbai. This Executive Job role is ideal for professionals who want to work on US and Canada regulatory submissions, product lifecycle management, and cross-functional collaboration in a leading global pharmaceutical company. Graduates seeking for B pharma jobs or M Pharma jobs can apply now.
Introduction of the Job
Apotex is hiring an Executive for Global Regulatory Affairs to support product lifecycle management, regulatory submissions, and compliance activities for the US and Canada markets. The Executive Job role is based in Mumbai.
Job Details for Executive Job Role:
- Responsible for product life-cycle management of Apotex products in US and Canada.
- Prepare submission and approval notifications for regulatory agencies.
- Maintain all documentation and database records as per systems and procedures.
- Lead or coordinate regulatory affairs projects as assigned.
About the Company
Apotex Inc. is a Canadian-based global health company known for providing affordable, innovative medicines to millions worldwide. With headquarters in Toronto and global offices including India, the company has a strong presence across the Americas through licensing and product acquisitions.
(For more details, visit the official company website.)
Key Responsibilities for Executive Job Role:
- Prepare and review quality regulatory PLCM submissions for US and Canada.
- Maintain and complete regulatory documents to ensure compliance.
- Provide support and regulatory guidance to teams.
- Coordinate deficiency responses and compile information on time.
- Work with cross-functional departments to resolve submission issues.
- Prepare and review post-approval supplements.
- Assess and review change control documents.
- Maintain regulatory databases and trackers for Executive Job.
- Coordinate with third-party manufacturers for required documents.
- Act as back-up for team members when needed.
- Ensure timely compilation and submission of PLCM submissions and responses.
- Interpret and ensure compliance with SOPs, RA policies and regulatory guidelines.
- Draft SOPs and regulatory documents when required.
- Communicate with internal and external partners regarding submission data.
- Follow all compliance, ethics, safety, and HR guidelines.
Educational Requirements
-
Graduate or Post-Graduate degree in Chemistry, Pharmacy, or Life Sciences.
Experience Required for Executive Job Role:
- Minimum 3 years of experience in US/CAN/EU/AUS-NZ regulatory markets.
- Knowledge of post-approval change submission requirements and variation package compilation.
Skills Required for Executive Job Role:
- Strong knowledge of global regulatory requirements.
- Ability to manage documentation and compliance processes.
- Good communication and teamwork skills.
- Understanding of safety, quality, and compliance programs.
- Ability to collaborate across departments and with external agencies.
How to Apply for Executive Job Role:
Graduates seeking for B pharma jobs or M Pharma jobs can apply now. Apotex provides an inclusive and accessible work environment. Candidates requiring accommodations during recruitment can inform the team during the interview or testing process.
