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Job Opportunity: Manager – Regulatory Affairs (External Manufacturing) at Sanofi- Apply before 28th Feb 2025

Sanofi
Pharmacareer

Website Sanofi

Join Sanofi in Building a Healthier, More Resilient World

About Sanofi

Sanofi is committed to turning the impossible into the possible by discovering, developing, and delivering medicines and vaccines to millions worldwide. We are looking for a Manager – Regulatory Affairs (External Manufacturing) to join our team and contribute to ensuring compliance and efficiency in regulatory processes.

Job Title

Manager – Regulatory Affairs (External Manufacturing)

Location

Mumbai, India

Industry

Pharmaceuticals | Healthcare | Clinical Research

Experience Required

8-12 years in Regulatory Affairs or Quality Assurance

Educational Qualification

B.Pharm / M.Pharm / MSc in Life Sciences

Application Deadline

28th February 2025

Key Responsibilities

1. Product Dossier Management for Export Products

  • Prepare and review renewal dossiers for products manufactured in Indian CMOs and exported to Russia, Ukraine, CIS countries, Sri Lanka, Nepal, Latin America, and other regions.
  • Develop and review dossiers for new and existing products manufactured at CMOs in South Korea, Thailand, and the Philippines.
  • Maintain and update renewal and new product dossiers for both Indian and overseas CMOs.
  • Handle post-approval variations, ensuring timely communication and implementation.
  • Coordinate with Global Regulatory Affairs (GRA), country regulatory affiliates, and Centers of Excellence (COE) for dossier submissions and documentation support.
  • Align regulatory strategies with affiliates or Global RA for site change submissions.
  • Update eTOC and dispatch dossiers through Veeva Vault.
  • Maintain and distribute normative documents to responsible quality managers.
  • Ensure compliance with GRA processes for all export product dossier management.
  • Manage the lifecycle of all products under External Manufacturing India.

2. Regulatory Status Management for Local Products

  • Prepare and manage applications for manufacturing licenses, WHO GMP certifications, COPP, import licenses, and Schedule M GMP certificates for external manufacturing sites.
  • Facilitate regulatory certificates for tender business at external manufacturing locations.
  • Write dossiers and coordinate with CMOs for dossier submission in domestic markets like Thailand and Korea.
  • Maintain regulatory compliance at external manufacturing sites, including applications for new manufacturing licenses, additional products, or surrendering licenses.
  • Send finished product samples and working standards to regulatory authorities as required.
  • Address and follow up on regulatory complaints.

3. Artwork Review

  • Review and approve packaging material artworks per regulatory requirements.
  • Assess and anticipate changes in artwork due to new regulations or guidelines.

4. Documentation & Compliance

  • Review change controls initiated by the Quality Management System (QMS) team for regulatory impact.
  • Initiate and evaluate Change Control Request Forms (CCRF) for global and regional products.
  • Participate in the change control committee.
  • Upload and maintain Annual Product Quality Reviews (APQR) in the PQR workspace.
  • Review documents affecting regulatory compliance and maintain an up-to-date regulatory database.
  • Develop and update Standard Operating Procedures (SOPs) for the department.

Candidate Profile

Experience & Skills

  • Regulatory & Quality Expertise: Strong knowledge of Regulatory Affairs and Quality Assurance principles.
  • Stakeholder Management: Ability to collaborate with internal and external partners effectively.
  • Analytical Abilities: Strong problem-solving and decision-making skills.
  • Communication & Leadership: Ability to work independently while maintaining effective communication with stakeholders.
  • Managerial Courage: Capable of making and implementing difficult decisions.

Languages Required

  • English (mandatory)
  • Hindi (preferred)

Why Join Sanofi?

  • Be part of a global pharmaceutical leader dedicated to improving healthcare.
  • Work in a collaborative environment with opportunities for professional growth.
  • Contribute to innovative regulatory solutions and impact global healthcare markets.

If you have the required experience and skills, apply now and help us build a healthier future!

To apply for this job please visit jobs.sanofi.com.