Apotex Hiring for Executive Global Regulatory Affairs in Mumbai with responsibilities, qualifications, experience requirements
Executive – Global Regulatory Affairs Job in Mumbai | Apotex Recruitment 2025
Apotex, a globally recognized pharmaceutical organization headquartered in Canada, is inviting applications for the position of Executive, Global Regulatory Affairs in Mumbai. This is a major opportunity for professionals with experience in regulatory submissions, product life-cycle management, and compliance across major international markets such as the US, Canada, EU, Australia, and New Zealand. Apotex Hiring for Executive Global Regulatory Affairs
Apotex is known worldwide for improving access to affordable generic, biosimilar, and innovative medicines. With a strong global presence, including regional offices in the United States, Mexico, and India, Apotex continues to expand its regulatory and technical teams to support its rapidly growing product portfolio. This job opening offers a dynamic career path for candidates seeking long-term growth in regulatory affairs.
This post provides a detailed breakdown of job responsibilities, required qualifications, preferred experience, skills, organizational expectations, and a step-by-step guide on how to apply. Apotex Hiring for Executive Global Regulatory Affairs
About Apotex
Apotex Inc. is the largest Canadian-based pharmaceutical company with a mission to improve worldwide access to high-quality, affordable medicines. With a strong presence across multiple markets such as the Americas, Europe, and Asia, Apotex operates a broad portfolio that includes: Apotex Hiring for Executive Global Regulatory Affairs
- Generic pharmaceuticals
- Biosimilars
- Innovative branded medicines
- Consumer health products
The company collaborates with multiple global partners, licensing authorities, and third-party manufacturers to strengthen its market presence and ensure product availability.
Apotex also focuses on research, development, transparency, regulatory compliance, and operational excellence. This job opportunity reflects the organization’s ongoing commitment to expanding its regulatory functions and ensuring robust product life-cycle management across key global markets. Apotex Hiring for Executive Global Regulatory Affairs
Job Summary
The Executive, Global Regulatory Affairs role is primarily responsible for the complete product lifecycle management (PLCM) of Apotex products in the US and Canadian markets. The role includes the preparation and submission of regulatory documents, coordination with multiple teams, maintaining key regulatory databases, and ensuring compliance with international guidelines. Apotex Hiring for Executive Global Regulatory Affairs
This position requires in-depth knowledge of post-approval submissions, regulatory change management, deficiency responses, and communication with health authorities or associated regulatory agencies.
The role is based in Mumbai (Mulund), Maharashtra and offers an excellent platform for candidates seeking a well-established career in global regulatory affairs. Apotex Hiring for Executive Global Regulatory Affairs
Detailed Job Responsibilities
The responsibilities for this role are comprehensive and require strong technical, analytical, and communication skills. Below is a detailed, expanded overview of what the Executive – Global Regulatory Affairs will handle: Apotex Hiring for Executive Global Regulatory Affairs
1. Regulatory Submissions and Life-Cycle Management
The selected candidate must:
- Prepare, review, and submit high-quality PLCM (Product Life-Cycle Management) submissions for the US and Canada markets.
- Coordinate and compile regulatory documentation required for variation filings and amendments.
- Ensure timely submission and approval of change notifications, supplements, and updates.
- Maintain accurate and complete documentation as per regulatory standards.
2. Support for Regulatory Compliance
Responsibilities include:
- Maintaining regulatory documents in line with global RA processes, system requirements, and SOPs.
- Ensuring all approved products in the US/Canadian markets remain compliant with the latest regulatory guidelines.
- Reviewing and assessing change control documents related to manufacturing, testing, packaging, and labeling.
3. Deficiency Response Management
The candidate will: Apotex Hiring for Executive Global Regulatory Affairs
- Assess deficiency letters issued by regulatory authorities.
- Coordinate with cross-functional departments to gather required information.
- Compile accurate and complete deficiency responses within defined timelines.
- Ensure clear communication and follow-up with responsible departments.
4. Cross-Functional Coordination
Effective collaboration is essential. The Executive RA must work with:
- Quality Assurance
- Regulatory Writing
- Production
- Analytical Development
- Packaging Development
- Third-party manufacturers
This coordination ensures timely submission of documents, proper resolution of issues, and adherence to regulatory commitments. Apotex Hiring for Executive Global Regulatory Affairs
5. Database and Document Tracking
The role includes:
- Maintaining and updating regulatory databases accurately.
- Managing trackers such as:
- PLCM review checklists
- Deficiency response trackers
- Submission planning spreadsheets
- Ensuring precision and version control across all regulatory documents.
6. SOPs, RA Guidelines, and Compliance
The candidate must:
- Interpret and follow SOPs, RA procedures, regulatory guidelines, and global standards.
- Draft or revise SOPs and regulatory guidelines when required.
- Follow internal compliance policies including ethics, safety, HR, and environment.
7. External Communication and Documentation
The Executive will: Apotex Hiring for Executive Global Regulatory Affairs
- Communicate with external agencies, partners, agents, and suppliers for data collection.
- Ensure seamless document flow between third-party manufacturers and Apotex RA teams.
- Handle regulatory documentation professionally and compliantly.
8. Team Support and Backup Responsibilities
The role includes:
- Acting as a backup for peer team members when necessary.
- Providing assistance and regulatory guidance to support completion of ongoing RA projects.
- Supporting team functionality during workload peaks or project deadlines.
9. Behavioral and Organizational Expectations
Apotex values the following behaviors:
- Integrity
- Courage
- Teamwork
- Innovation
Employees are expected to adhere to all global compliance programs including:
- Business Ethics and Compliance Program
- Global Quality Systems
- Safety and Environment Policies
- HR Policies
Job Requirements
Educational Qualification
Candidates must have:
- A Graduate or Post-Graduate degree in:
- Chemistry
- Pharmacy
- Life Sciences
- Other related scientific fields
Experience Requirements
Applicants must have:
- Minimum 3 years of regulatory affairs experience, specifically supporting:
- US
- Canada
- EU
- Australia / New Zealand (AUS-NZ)
Experience in post-approval change submissions and compiling variation packages for global markets is essential. Apotex Hiring for Executive Global Regulatory Affairs
Knowledge, Skills, and Abilities
Applicants should have:
- Strong understanding of post-approval submission requirements.
- Knowledge of regulatory guidelines for US FDA, Health Canada, EMA, TGA, Medsafe etc.
- Ability to prepare PLCM submissions including supplements, CBE-30, CBE-0, and Annual Reports.
- Strong communication, documentation, and cross-functional coordination skills.
- Ability to interpret regulatory data requirements.
- Accuracy in documentation, tracking, and planning.
KEY BOX: IMPORTANT JOB HIGHLIGHTS
Position: Executive – Global Regulatory Affairs
Company: Apotex Inc.
Location: Mumbai, MH – 400079
Experience Required: Minimum 3 years (US/CAN/EU/AUS-NZ markets)
Education: Graduate/Post-Graduate in Pharmacy, Chemistry, or Life Sciences
Role Type: Full-Time
Key Responsibilities: PLCM submissions, deficiency responses, RA compliance, cross-functional coordination, regulatory documentation
Application Mode: Online
How to Apply
Eligible candidates interested in this opportunity should apply through the official Apotex careers website. Follow the steps below: Apotex Hiring for Executive Global Regulatory Affairs
- Visit the official Apotex career portal.
- Search for the job title Executive, Global Regulatory Affairs or filter by location Mumbai.
- Carefully review the job responsibilities and qualification requirements.
- Prepare an updated resume highlighting relevant regulatory experience and market exposure (US/CAN/EU/AUS-NZ).
- Submit your application through the online portal with all required details.
- Await further communication from the Apotex recruitment team regarding screening or interviews.
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