Regulatory Manager

The Regulatory Manager – France is responsible for ensuring full compliance with national regulatory requirements and supporting the organization’s commercial and operational activities across the French market. This role oversees mandatory declarations, labeling and artwork compliance, and regulatory contributions to tender submissions, while serving as a key interface with French Competent Authorities and internal stakeholders. The ideal candidate has the requisites to be appointed as an Interim Responsible Pharmacist, being granted, for the replacement periods, with the same powers and attributions as those conferred on the Responsible Pharmacist; acting effectively exercises them during the replacement period (R-5112-7 of the Public Health Code).

Responsibilities:

Regulatory Affairs

• Prepare and submit mandatory national declarations, including annual inventory reports, sales declarations, shortage management plans, and other regulatory filings required by French authorities
• Ensure regulatory compliance of labeling and artwork, including review and approval of packaging, leaflets, and labeling updates, while maintaining full traceability and version control
• Monitor regulatory developments in France and the EU, providing guidance to internal and external stakeholders on evolving requirements and compliance expectations
• Support product lifecycle activities by coordinating with global regulatory teams to align national submissions with EU/EMA processes
• Manage all DMOS and Transparency (Loi Bertrand) declarations related to interactions with healthcare professionals, healthcare organizations, and patient associations

Tender Support

• Provide all regulatory documentation required for public and hospital tender submissions, including certificates, declarations of conformity, and product registration documents
• Ensure the accuracy and compliance of regulatory information included in tender responses
• Collaborate with Sales, Marketing and Supply Chain teams to support timely and competitive tender submissions

Cross‑Functional Collaboration

• Partner with internal teams—including Quality, Pharmacovigilance, Medical Affairs, Supply Chain, Commercial, and Legal—to ensure regulatory alignment across business activities
• Contribute to internal audits and inspections by preparing regulatory documentation and supporting corrective actions
• Train and advise internal stakeholders on French regulatory requirements, processes, and best practices   

External Interfaces

• Serve as a primary point of contact for Competent Authorities (e.g., ANSM), Notified Bodies, and relevant industry associations
• Coordinate with external partners such as subcontractors, suppliers, and regulatory consultants to ensure timely and compliant deliverables

* You should be legally authorized to work in the location without requiring any work sponsorship

Educational qualification: Degree in Life Sciences, Pharmacy, or a related field

Minimum work experience: 5 to 8 years of experience in pharmaceutical industry

Skills & attributes:

• Proven experience in regulatory affairs within the pharmaceutical, biotech, or medical device sector
• Strong knowledge of French and EU regulatory frameworks, including DMOS, Transparency, and ANSM requirements
• Excellent communication skills and the ability to work cross‑functionally in a fast‑paced environment
• Strong organizational skills with a high level of attention to detail

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

Equal Opportunity Employer

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender ...