Global Regulatory CMC Product Manager

at  Sanofi US

ABOUT THE JOB

We are currently on a journey where we are transforming how we support our Global Regulatory Affairs (GRA) teams to fulfil Sanofi’s strategic objectives and are looking for team members who can join us on this exciting journey.
Sanofi Global Regulatory Affairs is looking for a Product Manager Global Regulatory Affairs CMC Small Molecules in the R&D Hub in Budapest. This role will manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and investigational medicinal products for assigned portfolio. This position will provide input into the product strategy and to the direction provided to commercial and development teams.
The Product Manager is responsible for driving superior regulatory practices by championing operational excellence, organizational alignment, and superior execution. The Product Manager Global Regulatory Affairs CMC Small Molecules will be a critical member of a highly productive team, a collaborative team player, and driven problem-solving and improving ways of work.

• Responsible for developing innovative regulatory strategy and assuring this regulatory strategy is aligned with global Health Authority requirements and Sanofi’s internal standards, and delivering portfolio submissions per established project timelines and of high quality to achieve Corporate & Department goals
• Coordinate with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.
• Create collaborative working relationships with Global Regulatory Affairs (scopes: corporate, regional, national), Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/ Management, Regulatory Health Authorities
• Support CMC submission for development projects including clinical studies and registration, as needed.
• Lead the license maintenance with annual reports (US, Canadian NDC and YBPR, license and renewals) and site renewals (ex. Japan Accreditation)
• Be in charge of the regulatory strategy development by ensuring the preparation and review of submissions, the technical review of site supporting documents (CoA, SMF, MBR, SOPs), the notification of Reg Ops for publishing and dispatch to Health Authorities, the interaction with EMA and EU member states BoH on CMC topics
• Evaluate Global Regulatory CMC strategies and risks to develop projects and/or marketed products. Work closely with the CMC teams to implement aligned global regulatory strategies to ensure commercial supply chain continuity