Senior Manager – Regulatory Affairs
Location: Bangalore, Karnataka, India
Function: Research & Development
Employment Type: Full-Time
Experience Required: 6–7 years in Regulatory Affairs within India
Job ID: R00139037
Company Overview
AbbVie is a global biopharmaceutical leader focused on discovering and delivering innovative therapies across key therapeutic areas including immunology, oncology, neuroscience, eye care, and aesthetics. Through our Allergan Aesthetics portfolio, we provide transformative medical solutions that improve patient outcomes worldwide. Learn more at www.abbvie.com.
Role Overview
We are seeking a Senior Manager – Regulatory Affairs to lead and execute regulatory strategies for new and existing products in India. This role will collaborate closely with cross-functional teams including Medical Affairs, Drug Safety, Marketing, and Global Regulatory functions to ensure compliance, product registration, and timely approvals. The ideal candidate will have hands-on experience with new drug registration, clinical trials, and regulatory submissions in India.
Key Responsibilities
Regulatory Strategy & Submissions:
Develop and implement regulatory strategies for NDAs, sNDAs, and product lifecycle maintenance.
Manage renewals, variations, labeling updates, and compliance for registered products and companion diagnostics (CDx).
Collaborate with global and local teams during product development to ensure alignment on regulatory requirements and timelines.
Prepare documents proactively to minimize regulatory queries and expedite approvals.
Monitor regulatory legislation, marketing applications, and provide updates to internal stakeholders.
Liaise and negotiate with authorities to facilitate efficient regulatory approvals.
Business Support:
Independently lead regulatory discussions for new product introductions and launch plans.
Provide input on marketing campaigns, labeling, advertising, and promotional materials to ensure regulatory compliance.
Collaborate with NPI (New Product Introduction) teams to manage country-specific artwork, product launch planning, and lifecycle management.
Track regulatory approvals, variations, and line extensions to support timely business execution.
Compliance & Process Management:
Ensure all regulatory processes adhere to internal policies and Health Authority requirements.
Collaborate with Legal, Quality, Pharmacovigilance, and Supply Chain to maintain regulatory compliance across functions.
Review and approve promotional materials, labeling, and product information.
Maintain regulatory databases and track progress of submissions, deficiency responses, and artwork approvals.
Key Relationships:
External: Health Authorities, distributors, regulatory consultants.
Internal: Regulatory Affairs, Medical Affairs, Drug Safety, Global Regulatory, Clinical Development, Market Access, Marketing, Quality Assurance.
Qualifications & Experience
Education: Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Pharmaceutical Science, or Biomedical Science (B.Pharm, M.Pharm, MSc).
Experience: 6–7 years in Regulatory Affairs, preferably with experience in India’s regulatory environment.
Strong knowledge of new drug registration, clinical trials, product variations, labeling, and compliance requirements.
Proven ability to develop regulatory strategies, manage submissions, and liaise with Health Authorities.
Experience in cross-functional collaboration and regulatory agency interactions.
Strong analytical, project management, negotiation, and interpersonal skills.
Demonstrated ability to resolve regulatory challenges and drive results in a fast-paced environment.
Why Join AbbVie
Join a global leader in pharmaceutical innovation and gain the opportunity to lead regulatory strategies for groundbreaking therapies. AbbVie offers a collaborative, inclusive, and growth-focused environment with opportunities to influence healthcare outcomes on a national and global scale.
AbbVie is an equal opportunity employer, committed to integrity, innovation, and compliance with all applicable regulations.
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