
Abbott, a global powerhouse in the healthcare sector, has announced a senior-level vacancy for the position of Regulatory Affairs Manager at its Mumbai location. With a workforce of over 109,000 colleagues across 160 countries, Abbott continues to expand its branded generic medicines and diagnostics portfolio, seeking experienced professionals to lead their Chemistry, Manufacturing, and Controls (CMC) regulatory strategies.
This leadership role is critical for ensuring that life-changing medical technologies and medicines meet stringent global compliance standards while navigating complex registration pathways.
Key Roles & Strategic Responsibilities
1. Global Product Registrations
- Submission Management: Lead the preparation and request of documentation for complex global filings.
- Technical Advocacy: Seek expert technical support for high-stakes submissions and prepare robust responses to Health Agency deficiency letters.
- Lifecycle Management: Oversee routine filings and ensure data integrity throughout the product lifecycle.
2. Regulatory CMC Strategy
- Risk Mitigation: Identify and communicate Regulatory CMC risks, developing mitigation plans to ensure project progression.
- Compliance Oversight: Assess and approve change requests, ensuring that all products remain in compliance with evolving international legislation.
- Innovation: Support the development of position papers and identify process improvements to streamline regulatory workflows.
3. Stakeholder & Health Agency Interaction
- Cross-Functional Leadership: Represent the Regulatory department in project meetings, aligning global strategies with regional affiliate needs.
- Direct Interaction: Attend Health Agency meetings and provide expert CMC support during licensing reviews and due diligence activities.
Candidate Profile
1. Educational Qualifications
- Essential: Bachelor’s Degree in Pharmacy (B.Pharm), Biology, Chemistry, Pharmacology, or a closely related scientific discipline.
2. Experience & Competencies
- Experience: A minimum of 10 years in Regulatory Affairs, R&D, or Pharmaceutical Manufacturing.
- Technical Knowledge: Deep understanding of global and regional regulatory requirements and scientific principles related to pharmaceutical CMC.
- Project Management: Proven ability to monitor actual versus planned activities and meet strict regulatory deadlines.
Application Details
Interested candidates who meet the 10-year experience threshold are encouraged to apply through the Abbott careers portal before the end of the month.
- Location: Mumbai, India
- Functional Area: Regulatory Affairs
- Application Deadline: 28 February 2026
- How to Apply: Submit your updated CV and professional credentials via the official Abbott recruitment website.
