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Hnc Bu Regulatory Affairs Manager
Il y a 7 mois
The Regulatory Affairs Manager - Postbiotics/Lacteol/Lbiome 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 Lacteol/LBiome/LBiotix 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.
Location can be hybrid, but on site at Houdan part time is needed.
**Key Responsibilities**
- Provides regulatory leadership in support of the development, registration and maintenance of Lacteol/LBiome/LBiotix products by meeting the requirements of local and international regulations.
- 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, including variations related to CMC, clinical and labeling, 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.
- 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.
**Key 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 the regulatory aspects of labeling development and commercial product labeling management as well as advertising/promotion material for both pharma products and nutritional supplement products.
- Experience with preparing safety reports and evaluating safety requirements for prescription and nutritional products preferred.
- Experience of ANSM, EMA and other international health authorities.
- Excellent interpersonal written and oral communication skills in French and English; Additionally, Italian and Spanish language skills preferred.
**Important Note**
This job title is temporary and will be adjusted once the job grading structure for the new Group will be adopted (covering among others: grades’ design, job evaluations, calibration, and job titles’ nomenclature). Until these adjustments are finalized, current compensation packages will be grandfathered. This temporary period will last not more than 24 months for the legacy DSM Executives or legacy FIR SLT members, and not more than 12-18 months for all other employees.
