Regulatory Manager

Dr Reddy's Laboratories Limited

CDI Paris Pharmaceutique / Biotechnologique
Publiée le
26/03/2026
Contrat
CDI · Inconnue
Localisation
Paris
Taille équipe
Inconnue emp.
Rémunération
Inconnue
Inconnue 5-10 ans exp. Francais Anglais
Missions clés Assurer la conformité réglementaire avec les exigences nationales en France. · Préparer et soumettre les déclarations nationales obligatoires. · Collaborer avec les équipes internes pour soutenir les soumissions de marchés publics. · Former et conseiller les parties prenantes internes sur les exigences réglementaires françaises.
Profil recherché Bac +5 (Master 2, Diplôme d'ingénieur) · 5-10 ans d'expérience · Communication · Collaboration · Organisation · Attention au détail
Outils & compétences Regulatory Affairs, DMOS, Transparency, ANSM requirements

Le poste en détail

Company DescriptionAt 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 DescriptionThe 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 AffairsPrepare and submit mandatory national declarations, including annual inventory reports, sales declarations, shortage management plans, and other regulatory filings required by French authoritiesEnsure regulatory compliance of labeling and artwork, including review and approval of packaging, leaflets, and labeling updates, while maintaining full traceability and version controlMonitor regulatory developments in France and the EU, providing guidance to internal and external stakeholders on evolving requirements and compliance expectationsSupport product lifecycle activities by coordinating with global regulatory teams to align national submissions with EU/EMA processesManage all DMOS and Transparency (Loi Bertrand) declarations related to interactions with healthcare professionals, healthcare organizations, and patient associationsTender SupportProvide all regulatory documentation required for public and hospital tender submissions, including certificates, declarations of conformity, and product registration documentsEnsure the accuracy and compliance of regulatory information included in tender responsesCollaborate with Sales, Marketing and Supply Chain teams to support timely and competitive tender submissionsCross‑Functional CollaborationPartner with internal teams—including Quality, Pharmacovigilance, Medical Affairs, Supply Chain, Commercial, and Legal—to ensure regulatory alignment across business activitiesContribute to internal audits and inspections by preparing regulatory documentation and supporting corrective actionsTrain and advise internal stakeholders on French regulatory requirements, processes, and best practices   External InterfacesServe as a primary point of contact for Competent Authorities (e.g., ANSM), Notified Bodies, and relevant industry associationsCoordinate 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 sponsorshipQualificationsEducational qualification: Degree in Life Sciences, Pharmacy, or a related fieldMinimum work experience: 5 to 8 years of experience in pharmaceutical industrySkills & attributes:Proven experience in regulatory affairs within the pharmaceutical, biotech, or medical device sectorStrong knowledge of French and EU regulatory frameworks, including DMOS, Transparency, and ANSM requirementsExcellent communication skills and the ability to work cross‑functionally in a fast‑paced environmentStrong organizational skills with a high level of attention to detail Additional InformationOur 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 EmployerAn 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/#!/ Full-time