Job Title: Manager, Regulatory Affairs - External Manufacturing
Location: Bombay, India
Job Type: Permanent
Posted: Feb. 07, 2025
Expires: Mar. 28, 2025
Main Responsibilities
Product Dossier Management for Export Products:
Write and review renewal dossiers for products manufactured at Indian CMOs and exported to various countries (e.g., Russia, Ukraine, Sri Lanka, Nepal, Latin America).
Manage new product dossiers/renewal dossiers for products manufactured in South Korea, Thailand, and the Philippines for export markets.
Maintain all dossiers for Indian and overseas CMOs.
Handle post-approval variations and communicate necessary changes to stakeholders.
Coordinate with Global Regulatory Affairs (GRA), country regulatory affiliates, and COE for submission support.
Consolidate regulatory strategies with affiliates and Global RA for site changes.
Update eTOC and dispatch dossiers through Veeva Vault.
Distribute normative documents to quality managers.
Manage lifecycle for all export products and follow GRA processes.
Regulatory Status Management for Local Products:
Prepare applications for manufacturing licenses, WHO GMP certificates, import licenses, and other regulatory certificates for external manufacturing sites.
Manage regulatory status for external manufacturing sites by preparing applications for new licenses, additional products, or surrendering unnecessary licenses.
Handle product samples/working standards and respond to regulatory authorities’ inquiries.
Artwork Review:
Review and approve packaging material artworks per regulatory requirements.
Evaluate changes in artworks based on new regulations or guidance.
Documentation:
Review and assess the impact of change controls initiated by the QMS team.
Participate in change control committees and initiate evaluations for global and regional products.
Maintain the regulatory database and ensure documents are up to date.
Prepare and maintain SOPs for the department.
Pharmacopoeia Changes:
Review pharmacopoeia changes affecting EM India’s product portfolio and plan actions for implementation.
About You
Experience:
8-12 years in Regulatory Affairs and Quality Assurance.
Soft Skills:
Strong transversal skills and stakeholder management.
Effective communication with external partners and ability to work independently.
Technical Skills:
Expertise in Regulatory Affairs and Quality Assurance.
Strong analytical skills and the ability to collaborate cross-functionally.
Education:
B.Pharm, M.Pharm, or MSc in Life Sciences.
Languages:
Proficiency in English and Hindi.
Why Sanofi?
At Sanofi, we believe in the power of progress and creating extraordinary outcomes. We seek passionate people from diverse backgrounds, united by a desire to make meaningful contributions to global healthcare. We are committed to diversity, equity, and inclusion, offering equal opportunities for all, regardless of race, gender, disability, or other factors.
Join Us:
By joining Sanofi, you will help drive progress, embrace new ideas, and explore endless possibilities. Together, let’s create a future of healthcare excellence.
[Apply Now]
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