Regulatory Manager at Dr Reddy's Laboratories Limited

Paris, Ile-de-France, France -

Full Time

Start Date

Immediate

Expiry Date

24 Jun, 26

Salary

0.0

Posted On

26 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Compliance, French Regulatory Requirements, EU Regulatory Frameworks, Labeling, Artwork Compliance, Tender Submissions, Competent Authorities Interface, DMOS Declarations, Transparency (Loi Bertrand), Pharmacovigilance, Quality Assurance, Supply Chain Collaboration, Audits, Inspections, Stakeholder Training

Industry

Pharmaceutical Manufacturing

Description

Company Description At Dr Reddy's "Good Health Can't Wait" By joining Dr Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. Diversity, Equity & Inclusion At Dr Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. Job Description 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 Qualifications 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 Additional Information 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 identity, national origin, or protected veteran status and will not be discriminated against based on disability. For more details, please visit our career website at https://careers.drreddys.com/#!/ Job Family: Regulatory Affairs Sub Job Family: Regulatory Affairs General Preferred type of working: On-Premise Years of Experience: 6 - 12 Business unit: EUG

Responsibilities

The Regulatory Manager is responsible for ensuring full compliance with French national regulatory requirements, overseeing mandatory declarations, labeling compliance, and supporting tender submissions while interfacing with Competent Authorities. This role also involves acting as an Interim Responsible Pharmacist when required, exercising the powers and attributions of that position.