Regulatory Responsible

at  Sanofi

REGULATORY RESPONSIBLE

The position holder is accountable to lead CMC (Chemistry Manufacturing and Control) activities inside of the regulatory team reporting directly to the Team Leader. This position is essential to guarantee the supply continuity by maintaining the Marketing Authorization of our drug products and driving the regulatory strategy to faster the implementation in case of need. The position holder is the focal point for the CMC expertise for all projects linked to the dedicated portfolio and a key part of business and innovation.

WHEN JOINING OUR TEAM, YOU WILL EXPERIENCE:

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
• An attractive, market-oriented salary and cafeteria benefits
• Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days
• Collective life and accident insurance
• Yearly medical check-up
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Your own career path within Sanofi. Your professional and personal development will be supported purposefully
• Practice your language skills within our “Language Club”
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

• CMC Documentation management
• Writes, updates and / or reviews CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submission.
• Coordinates CMC writing performed by another entity (internal or external).
• Optimizes the content of CMC dossiers to facilitate the management of future changes by checking the relevant level of information to be provided.
• Prepares with contribution of CMO experts the answers to questions from Health AuthoritiesSupports Marketing Authorisations worldwide (territory extensions, renewals, site registrations and transfers…) by writing and / or reviewing the corresponding CMC documents/dossiers and collecting GMP related documents.
• Change Control
• Evaluates the regulatory impacts of changes during the product life cycle in accordance with the Change Control procedure in force.
• Defines the regulatory strategy and participate in change controls meetings.
• Follows the submissions and approvals of variation files in each country.
• Regulatory Compliance
• Ensures that the CMC dossier is in line with the manufacturing and control procedures at the related CMO.
• Evaluates the regulatory compliance of current dossiers versus manufacturing site practices and current regulations and highlights discrepancies.
• Ensures the definition of corrective actions for gap closure.
• Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs for EM CHC.
• Supports business unit in the assigned region in the management of new business opportunities and product launches.