Regulatory Manager
Share
Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
The Regulatory Manager France is responsible for ensuring full compliance with national regulatory requirements and supporting the organizations 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 (Rof 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
CrossFunctional Collaboration
- Partner with internal teamsincluding Quality Pharmacovigilance Medical Affairs Supply Chain Commercial and Legalto 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
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 crossfunctionally in a fastpaced environment
- Strong organizational skills with a high level of attention to detail
Additional Information :
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Dr. Reddys Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Cant Wa ... View more
