Senior Manager Regulatory Affairs
Adare Pharma Solutions, France
Job Description
Would you like to be part of a company that has revolutionized the microbiome by pioneering the field of postbiotics? Come join us at Adare Biome!
Adare Biome is a division of Adare Pharma Solutions, a global technology driven CDMO.
Adare Biome, located in Houdan near Paris, is a pharmaceutical company specializing in the microbiome and postbiotics manufacturing, thanks to its patented Lactobacillus LB strain and its proprietary ECHO fermentation process that enriches, concentrates and heat treats microorganisms.
At Adare Biome, we believe that caring for the health and well-being of everyone is essential. And to do that, innovation is key.
Our mission is to develop, produce and commercialize high-quality postbiotic solutions, including its landmark drug Lactéol marketed in 40 countries worldwide, but also its ingredients for human and animal digestive health applications.
Each position and department at Adare Biome offer a unique and personalized experience with a chance to make a real impact and is critical to our success.
What can Adare offer you?
- A dynamic and exciting work environment
- Career development and internal opportunities
- A social policy offering numerous benefits (CSE, meal vouchers, etc.) including bonuses based on collective and individual performance
- Employee recognition programs
- A pleasant work environment surrounded by nature
We are looking to hire a Senior Manager Regulatory Affairs to join Adare Biome's Regulatory Affairs team.
If you see yourself in the statement below, we would love to meet you!
JOB SUMMARY
The Regulatory Manager is responsible for providing a proactive and effective regulatory Affairs and pharmacovigilance support related to the development, marketed products pre and post approval commitment, registration and marketing activities associated with advertise and promotional of the products Such support is provided through the identification, implementation and management of regulatory strategies, preparation of regulatory documents for the filings, interactions with local and international regulatory authorities and the filing maintenance. Other responsibilities are linked to the GMP area, through the definition and implementation of activities to support commercial products.
- Provides regulatory leadership in support of the development, registration, and maintenance of products by meeting the requirements of local and international regulatory affairs requirements.
- Develops and implements short- and long-term regulatory strategies to achieve product development goals and to support life cycle management projects for commercial products under responsibility.
- Ensures that all strategic and tactical activities are conducted in accordance with applicable regulations working closely with the internal departments and across project teams.
- Ensures clear communication of project activities and progress in a timely manner.
- Collaborates with Regulatory team for the preparation and filing of regulatory submissions to support new product approvals and commercial products (including labeling).
- Collaborates with Regulatory team to ensure submissions are complete, properly formatted and comply with applicable regulatory requirements.
- Serves as a key contact with French Health Authorities and facilitates communication between French Health Authorities and the project team.
- Leads cross functional teams and oversees the planning and coordination of productive and effective regulatory submissions and regulatory agency meetings.
- Provide support with local and global pharmacovigilance activities and ensures compliance of the pharmacovigilance system with all applicable regulations.
- Provide support for labeling and advertisement and promotional materials related activities and ensures compliance of labeling and Ad/pro materials met all applicable requirements.
- Collaborates with Regulatory team to ensure timely and appropriate regulatory management of changes to products for CMC, clinical and labelling, as applicable.
- Maintains a high level of professional expertise through familiarity with guidelines, scientific literature, and participation in training courses
Requirements
- BS/BA degree from a four-year accredited university or college; Scientific or regulatory affairs master is preferred; plus 10 years of related experience required
- Regulatory experience associated with the registration of microbiome prescription and nutritional supplement products in France with experience in additional registration territories preferred
- Experience with animal health product not required but preferred
- Experience with the regulatory aspects of labeling development and co