Senior Manager – Regulatory Affairs
Location: Bangalore, Karnataka, India
Employment Type: Full-time
Global Grade: Workday Grade 16
About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to discovering and delivering innovative medicines and solutions that address serious health challenges. With a strong presence across immunology, oncology, neuroscience, eye care, and the Allergan Aesthetics portfolio, AbbVie’s mission is to make a meaningful difference in patients’ lives worldwide.
Operating at the intersection of science and innovation, AbbVie fosters a collaborative, inclusive, and high-performance culture that empowers professionals to drive regulatory excellence and sustainable growth.
Job Summary
AbbVie is seeking an experienced Senior Manager – Regulatory Affairs to lead and manage regulatory strategy and compliance activities for the India region. This role is responsible for end-to-end regulatory lifecycle management, including new drug applications, variations, renewals, labeling, and promotional compliance. The position requires strong cross-functional collaboration, regulatory intelligence expertise, and direct interaction with health authorities to ensure timely approvals and compliance with evolving regulations.
Key Responsibilities
Regulatory Strategy & Submissions
Develop and execute regulatory strategies, including filing readiness for NDAs and sNDAs
Lead regulatory planning for new product introductions, lifecycle management, and line extensions
Manage renewals, variations, and maintenance of registered pharmaceutical products and companion diagnostics (CDx/devices)
Collaborate with global and regional regulatory teams during early-stage development to provide regulatory guidance on data and documentation requirements
Anticipate potential regulatory queries and ensure proactive preparation of responses to minimize approval timelines
Monitor and track marketing authorization applications through regulatory systems and provide regular status updates
Regulatory Intelligence & Authority Interaction
Maintain up-to-date knowledge of Indian regulatory legislation, policies, and procedural changes
Monitor SEC recommendations, CTRI updates, and regulatory intelligence sources relevant to product registration
Liaise and negotiate with regulatory authorities to facilitate efficient and timely approvals
Contribute to regulatory policy development by providing inputs on draft guidelines and regulations
Business & Commercial Support
Independently lead regulatory strategy discussions for new and existing products with area and global regulatory teams
Partner with commercial, marketing, and NPI teams to support launch planning, supply chain readiness, and country-specific artwork development
Provide regulatory input for marketing strategies, campaigns, and product claims to ensure compliance with labeling and promotional regulations
Review and approve labeling, advertising, and promotional materials in alignment with approved product information and local guidelines
Support institutional and business requirements by facilitating documentation such as Market Standing Certificates, GMP certificates, manufacturing licenses, and related regulatory documents
Regulatory Compliance & Process Excellence
Ensure full compliance with internal AbbVie policies and local health authority requirements
Manage remediation plans to address identified compliance gaps
Coordinate with Legal, Medical Affairs, Pharmacovigilance, Quality, Supply Chain, and other stakeholders to ensure regulatory alignment
Oversee variation submissions, deficiency responses, and approval tracking for marketed products
Manage labeling changes, artwork development, and packaging material approvals
Maintain accurate and up-to-date regulatory databases and documentation
Key Stakeholder Relationships
External: Health Authorities, Distributors, Regulatory Consultants
Internal: Regulatory Affairs, Medical Affairs, Drug Safety, Global Regulatory, Clinical Development, Market Access, Marketing, Quality Assurance, Supply Chain
Education & Qualifications
Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Biomedical Sciences, Pharmacy (B.Pharm / M.Pharm), or equivalent
Experience Required
6–7 years of progressive experience in Regulatory Affairs, with strong exposure to the India regulatory environment
Proven experience in new drug registrations and clinical trial regulatory processes in India
Prior experience in regulatory agency interactions and submission management is highly preferred
Essential Skills & Competencies
In-depth knowledge of Indian regulatory frameworks and drug approval processes
Strong regulatory strategy, project management, and lifecycle management expertise
Excellent written and verbal communication, negotiation, and stakeholder management skills
Ability to operate effectively in a fast-paced, matrixed, and evolving regulatory environment
Strong cross-functional collaboration and problem-solving capabilities
Commercial acumen with the ability to align regulatory strategy to business objectives
Why Join AbbVie
Opportunity to work with a globally recognized biopharmaceutical leader
Exposure to complex, high-impact regulatory programs across multiple therapeutic areas
Collaborative culture that values innovation, integrity, and continuous learning
Strong career growth and leadership development opportunities
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