Purpose
Lead overall regulatory activities for the Vaccines portfolio, ensuring compliance, strategic market authorizations, and effective collaboration with regulatory authorities, government bodies, industry associations, and internal/external stakeholders.
Main Accountabilities
Provide regulatory ownership and business acumen to support the Vaccines Business Unit (BU) across India, Nepal, and Sri Lanka.
Develop and implement strategic regulatory pathways to accelerate market authorizations for Sanofi products.
Collaborate with Global Regulatory Affairs (GRA) to ensure business continuity for submissions, approvals, renewals, and post-approval changes.
Ensure product packaging, labeling, and associated information are updated, implemented, and maintained in accordance with licenses.
Review and approve promotional and non-promotional materials in compliance with local regulations, codes of conduct, and internal guidelines.
Monitor emerging regulatory requirements and assess their impact on current and future products.
Provide regulatory input to portfolio optimization and product pruning strategies at affiliate and global levels.
Ensure implementation of GRA SOPs and training, and maintain accuracy in regulatory databases (e.g., VAULT, STARR).
Represent Regulatory Affairs in the senior leadership team for Vaccines BU.
Build strong relationships with regulatory authorities (CDSCO, CDTL, CDL), and government bodies (e.g., Ministry of Health, IPC, NPPA).
Shape the regulatory environment through participation in industry associations and collaboration with Public Affairs.
Work with cross-functional teams (supply chain, quality, medical, commercial) to provide timely regulatory guidance for product launches and business continuity.
Lead, mentor, and develop the Regulatory Affairs team.
Knowledge, Skills & Competencies
Strong knowledge of Indian regulations governing biological products and medical devices.
Ability to plan, prioritize, and manage projects effectively.
Proven people leadership and project management skills.
Excellent verbal, written, negotiation, and interpersonal communication skills.
Ability to work efficiently in a multicultural and cross-functional environment.
Strategic foresight to identify risks, opportunities, and regulatory priorities.
Qualifications
Education: M.Pharm, M.Sc., Pharm D, or equivalent (preferred).
Experience: Minimum 12 years of regulatory experience in a pharmaceutical company.
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Why Work With Us
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Our Commitment
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