Regulatory Affairs Analyst Job in Mumbai GBS GRA PLCM Role at Apotex. Pharmacy and life sciences graduates with experience apply.
Pharmaceutical regulatory affairs continues to be a high-demand career path, especially in product life-cycle management (PLCM) functions. If you have experience working with regulatory systems and submission documentation, this opportunity in Mumbai could be an excellent next step. Apotex is currently hiring for the position of Analyst, GBS GRA PLCM at its Mumbai location.
This role focuses on managing post-approval regulatory activities, documentation maintenance, and coordination with internal and external stakeholders to ensure compliance across global markets. Regulatory Affairs Analyst Job in Mumbai
Company Overview
Apotex Inc. is a Canada-based global pharmaceutical company headquartered in Toronto. The organization develops and markets a wide portfolio of generic medicines, biosimilars, innovative branded pharmaceuticals, and consumer health products. With operations across North America, Latin America, and India, Apotex is recognized as the largest Canadian-based pharmaceutical manufacturer. Regulatory Affairs Analyst Job in Mumbai
The company works closely with global partners for licensing, product acquisition, and regulatory expansion across international markets. Its focus remains on delivering affordable and high-quality healthcare solutions worldwide.
Job Location & Employment Type
- Job Title: Analyst, GBS GRA PLCM
- Location: Mumbai, Maharashtra (400079)
- Department: Global Regulatory Affairs – Product Life-Cycle Management (PLCM)
- Employment Type: Full-Time
- Experience Required: Minimum 1 Year
This is an on-site regulatory affairs position requiring coordination across multiple departments. Regulatory Affairs Analyst Job in Mumbai
Department & Functional Scope
The selected candidate will work within the Global Business Services (GBS) – Global Regulatory Affairs (GRA) division. The primary responsibility is managing product life-cycle activities for approved pharmaceutical products in identified international markets. Regulatory Affairs Analyst Job in Mumbai
Key Roles & Responsibilities
The Analyst will support regulatory compliance and post-approval submissions while ensuring documentation accuracy.
Core Responsibilities
- Prepare and compile quality post-launch PLCM submission packages for multiple markets.
- Maintain regulatory documentation in line with company systems and procedures.
- Prepare submission notifications and approval updates for regulatory authorities.
- Assess, compile, and coordinate deficiency response documents within agreed timelines.
- Evaluate and prepare post-approval supplements for life-cycle management.
- Review and assess change control documents and provide regulatory impact analysis.
- Maintain regulatory databases and trackers such as:
- PLCM review checklists
- Deficiency trackers
- Submission spreadsheets
- Coordinate with third-party manufacturers for documentation required for submissions.
- Communicate with internal departments to collect and compile submission data.
- Ensure timely follow-up to meet submission and query response deadlines.
- Interpret and implement SOPs, regulatory policies, and guidelines.
- Draft or update SOPs and regulatory documents when required.
- Act as backup for team members when needed.
Compliance & Quality Responsibilities
- Ensure compliance with Global Quality and Regulatory policies.
- Maintain adherence to Safety and Environmental guidelines.
- Follow Global Business Ethics and Compliance Programs.
- Demonstrate organizational values including Integrity, Teamwork, Courage, and Innovation.
- Collaborate cross-functionally to resolve regulatory issues.
Regulatory Affairs Analyst Job in Mumbai
Eligibility Criteria
Educational Qualification
Candidates must possess:
- Graduate or Postgraduate degree in:
- Pharmacy
- Chemistry
- Life Sciences
- Or related scientific disciplines
Experience
- Minimum 1 year of experience in regulatory affairs.
- Experience in handling regulatory systems and software tools used by regulatory professionals.
- Exposure to product life-cycle management activities preferred.
Knowledge, Skills & Abilities
Applicants should have:
- Understanding of pharmaceutical company operations.
- Awareness of Regulatory Affairs department functions.
- Knowledge of post-approval variation and supplement submissions.
- Familiarity with regulatory database systems.
- Strong documentation and organizational skills.
- Ability to interpret regulatory guidelines.
- Strong communication skills for internal and external coordination.
- Ability to manage multiple deadlines effectively.
- Team-oriented mindset with attention to detail.
Candidates with hands-on experience in regulatory submission systems will be preferred. Regulatory Affairs Analyst Job in Mumbai
Salary & Benefits
Salary details have not been disclosed and will be offered as per company norms based on candidate experience and internal evaluation. Regulatory Affairs Analyst Job in Mumbai
Apotex offers:
- Competitive compensation aligned with industry standards.
- Exposure to global regulatory markets.
- Structured corporate work environment.
- Inclusive and accessible workplace policies.
- Supportive work culture promoting professional growth.
Accommodation support is available for candidates with disabilities as part of the recruitment process.
Selection Process
The recruitment process may include:
- Online application submission.
- Resume shortlisting.
- Technical interview focusing on regulatory knowledge and PLCM processes.
- Practical assessment on submission documentation (if applicable).
- HR discussion.
- Final offer release.
Candidates should prepare thoroughly in post-approval regulatory processes, change control assessment, and global regulatory guidelines.
How to Apply
Interested candidates should apply through the official Apotex careers portal.
Visit: www.apotex.com
Search for: Analyst, GBS GRA PLCM
Location: Mumbai
Submit your application online through the company’s official recruitment system.
Important Dates
- No application deadline has been specified. Early application is recommended.
Why Apply for This Regulatory Affairs Role?
This opportunity offers significant professional advantages:
- Exposure to global post-approval regulatory submissions.
- Hands-on involvement in product life-cycle management.
- Experience working with international markets and regulatory authorities.
- Opportunity to develop regulatory documentation expertise.
- Strong foundation for career progression in Global Regulatory Affairs.
- Experience in compliance-driven pharmaceutical operations.
For professionals aiming to strengthen their regulatory career in life-cycle management and post-approval submissions, this role provides valuable exposure. Regulatory Affairs Analyst Job in Mumbai
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform sharing employment updates for informational purposes only. We are not affiliated with Apotex or its recruitment team. Applicants are advised to verify job details directly through the official company website before applying. We do not charge any fees for job applications or postings. Regulatory Affairs Analyst Job in Mumbai
Final Call-to-Action
If you have at least one year of experience in regulatory affairs and are looking to expand your expertise in product life-cycle management, consider applying for this Mumbai-based opportunity. Update your resume with relevant submission experience and apply through the official portal at the earliest to improve your chances of selection. Regulatory Affairs Analyst Job in Mumbai
