Job Title: Senior Manager – Regulatory Affairs
Location: Bengaluru, India
Employment Type: Full-Time
Workday Global Grade: 16
Experience Required: 6–7 Years (India Regulatory Affairs)
AbbVie is seeking a highly experienced Senior Manager – Regulatory Affairs to lead and execute regulatory strategies for new and marketed products in India. This leadership role is responsible for new drug applications, lifecycle management, regulatory compliance, and cross-functional collaboration, ensuring timely approvals and sustained compliance with Indian health authority requirements.
This position plays a critical role in aligning global regulatory strategies with local regulatory frameworks, supporting product development, launches, and post-approval maintenance across AbbVie’s diverse therapeutic portfolio.
Develop and execute regulatory strategies, including filing readiness for NDAs and sNDAs
Manage renewals, variations, and lifecycle maintenance of registered products and companion diagnostics (CDx/devices)
Collaborate with global development teams during early-stage product development to provide regulatory input on data and submission requirements
Ensure timely preparation and availability of documents to proactively address potential regulatory queries
Monitor marketing application progress and regulatory milestones within the Indian regulatory system
Maintain up-to-date knowledge of Indian regulatory legislation, guidelines, and policy updates
Monitor SEC recommendations, CTRI updates, and regulatory intelligence relevant to product registrations
Liaise and negotiate with health authorities to facilitate timely approvals
Contribute to regulatory policy discussions by providing inputs on draft guidelines and regulations
Independently lead new product regulatory strategy discussions with area and global regulatory teams
Partner with commercial and NPI teams to support product launch planning, artwork development, and labeling strategy
Manage product lifecycle activities including variations, labeling updates, renewals, and compliance testing
Provide regulatory oversight for marketing, advertising, and promotional materials, ensuring compliance with local regulations
Support institutional business needs by coordinating regulatory documents such as Market Standing Certificates, GMP certificates, manufacturing licenses, and proprietary article certificates
Ensure 100% compliance with internal policies, SOPs, and Health Authority requirements
Coordinate with Legal, Medical Affairs, Pharmacovigilance, Quality, and Supply Chain teams to ensure regulatory compliance
Review and manage variation submissions, deficiency responses, and labeling changes
Maintain and update regulatory databases and documentation systems
Internal:
Regulatory Affairs, Medical Affairs, Drug Safety, Global Regulatory, Clinical Development
Market Access, Marketing, Quality Assurance, Supply Chain
External:
Health Authorities, Distributors, Regulatory Consultants
Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Biomedical Sciences, or equivalent
Preferred qualifications: B.Pharm, M.Pharm, MSc
6–7 years of hands-on Regulatory Affairs experience focused on the India region
Proven experience in new drug registrations and clinical trial regulatory processes in India
Strong expertise in Indian regulatory frameworks and Health Authority interactions
Proven ability to work in a fast-paced, matrixed, and evolving environment
Excellent communication, negotiation, and stakeholder management skills
Strong project management, analytical, and commercial acumen
Demonstrated success in cross-functional collaboration
Ability to anticipate regulatory risks and develop effective mitigation strategies
Knowledge of sub-regional regulatory requirements is an added advantage
AbbVie is a global, research-driven biopharmaceutical company committed to discovering and delivering innovative medicines that address serious health challenges. With leadership across immunology, oncology, neuroscience, eye care, and aesthetics, AbbVie continues to make a meaningful impact on patients’ lives worldwide.
AbbVie is an Equal Opportunity Employer, committed to integrity, innovation, diversity, and inclusion.
Access senior-level Regulatory Affairs leadership roles with global pharmaceutical companies
Discover verified opportunities aligned with global regulatory and compliance standards
Advance your career in drug development, regulatory strategy, and market access
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