Manager – Regulatory Affairs
Location: Mumbai, Maharashtra, India
Function: Regulatory Affairs
Employment Type: Full-Time (Individual Contributor)
Company Overview
Abbott Laboratories is a global healthcare leader committed to delivering high-quality pharmaceutical products through strong regulatory governance, scientific excellence, and compliance-driven processes. In India, Abbott plays a pivotal role in ensuring lifecycle regulatory excellence across therapeutic portfolios.
Role Overview
The Manager – Regulatory Affairs is a senior individual contributor responsible for leading Regulatory CMC (Chemistry, Manufacturing & Controls) activities across product registrations, lifecycle management, and compliance initiatives. This role requires strong project management capabilities, cross-functional collaboration, and in-depth knowledge of global and regional regulatory requirements.
This opportunity is ideal for experienced regulatory professionals seeking Regulatory Affairs Manager jobs in Mumbai within a global pharmaceutical environment.
Key Responsibilities
1. Product Registrations & Submissions
Lead preparation and submission of complex product registrations and regulatory filings.
Compile, review, and request required documentation for routine and complex submissions.
Prepare responses to deficiency letters and regulatory queries.
Apply structured project management approaches to ensure adherence to submission timelines.
Identify, collect, and validate CMC data required for filings.
2. Cross-Functional Collaboration & Stakeholder Engagement
Represent Regulatory CMC in project meetings and communicate the agreed regulatory position.
Monitor and report actual versus planned regulatory timelines and milestones.
Identify, communicate, and mitigate risks impacting regulatory progress.
Maintain strong coordination with Regional Product Leads and affiliate teams.
3. Lifecycle Compliance Management
Assess and approve change control requests to maintain regulatory compliance.
Monitor regulatory legislation updates and evolving compliance standards.
Ensure continued compliance of approved products throughout their lifecycle.
4. Regulatory Strategy Development
Develop and implement Regulatory CMC strategies for assigned products.
Identify regulatory risks and propose mitigation plans aligned with business objectives.
5. Process Improvement & Governance
Identify operational improvement opportunities within Regulatory Affairs.
Contribute to development of position papers, SOPs, and work aids.
6. Health Authority Interaction & Licensing
Participate in Health Agency meetings as required.
Provide CMC regulatory support for licensing reviews and due diligence activities.
7. Technical & Regulatory Expertise
Maintain strong knowledge of CMC principles and allocated product portfolios.
Demonstrate understanding of global and regional regulatory frameworks.
Apply specialist knowledge relevant to assigned country or product-class requirements.
Core Competencies
Adaptability
Effectively manage mid- to long-term regulatory priorities.
Re-prioritize tasks based on evolving regulatory or business needs.
Initiative & Innovation
Proactively anticipate and mitigate regulatory risks.
Identify innovative solutions to regulatory challenges.
Seek feedback and continuously enhance performance.
Integrity & Compliance Orientation
Deliver accurate, high-quality submissions within agreed timelines.
Maintain transparency and ethical conduct in regulatory communications.
Team Collaboration
Work effectively with cross-functional stakeholders to achieve shared regulatory objectives.
Leadership Competencies
Strategic Vision
Clearly articulate Regulatory CMC strategies and gain stakeholder alignment.
Organizational Development
Mentor junior colleagues and support capability development.
Demonstrate leadership behaviors in daily operations.
Decision-Making & Results Orientation
Support efficient cross-functional decision-making processes.
Drive timely execution of regulatory commitments.
Open Communication & Knowledge Sharing
Provide constructive feedback and encourage open dialogue.
Promote knowledge exchange within Regulatory and cross-functional teams.
Educational Qualifications
Bachelor’s Degree in Pharmacy, Biology, Chemistry, Pharmacology, or related Life Sciences discipline.
Advanced degree preferred.
Experience Required
Minimum 10 years of experience in Regulatory Affairs, R&D, Manufacturing, or related pharmaceutical functions.
Demonstrated expertise in Regulatory CMC submissions and lifecycle management.
Experience interacting with health authorities and managing complex filings.
Strong understanding of global regulatory frameworks and compliance standards.
Supervisory Responsibility
Individual Contributor (No Direct or Indirect Reports).
Why Join Abbott?
Opportunity to lead high-impact regulatory strategies within a global pharmaceutical organization.
Exposure to complex CMC submissions and lifecycle regulatory governance.
Career advancement within Regulatory Affairs leadership pathways.
SEO & GEO Keywords: Regulatory Affairs Manager Mumbai, CMC Regulatory Jobs India, Pharma Regulatory Affairs Careers Maharashtra, Regulatory CMC Manager Jobs Mumbai, Health Authority Submission Jobs India, Abbott Regulatory Affairs Jobs Mumbai.
This role is designed for experienced regulatory professionals seeking Manager – Regulatory Affairs positions in Mumbai with strong exposure to CMC strategy, compliance oversight, and global regulatory engagement within a leading healthcare organization.
Uttar Pradesh :
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Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Siliguri |Illinois :
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Tallinn |Hà Nội :
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