Job title: Global Regulatory CMC Product Manager

• Location: Budapest
• 60% Remote working and 40% office
• Job type: Permanent, Full time

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.

Main responsibilities:

• 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

About you

Experience:

• 3+ years of experience in a regulatory function within a matrix environment
• Knowledge and experience of EU, FDA, and global regulations is a plus
• Business acumen and knowledge
• Track record with workforce capacity planning / productivity
• Success in developing and managing a strategy and planning process

Soft skills:

• Strong communication, leadership, teamwork, and organizational skills
• Proven ability to build effective relationships with diverse stakeholders and functions
• Strong interpersonal skills with demonstrated ability to influence stakeholders and team members within a matrixed organization

Technical skills:

• Working knowledge in Microsoft Office and Windows (Outlook, Word, Excel, PowerPoint), web skills a plus
• Working knowledge in Vault RIM and/or similar systems

Education:

• Bachelor's degree, or ideally a Master's degree, in a scientific, healthcare, or life sciences field.
• RAC certification is an asset

Languages:

• Excellent written and verbal communication skills in English

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Work from an "Office of the Year 2023" award winner with flexible home office policy
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your