Job title: Product Manager for Chemistry Manufacturing & Control (CMC) - Biologics and Vaccines

Location: Budapest, Hungary

Flexible working: 60% office 40 % home

Job type: Permanent, Full-time

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Join our Chemistry Manufacturing & Control (CMC) Team as Product Manager for Chemistry Manufacturing & Control (CMC) - Biologics and Vaccines and you’ll manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical products for the Sanofi portfolio. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams.

Main responsibilities:

• Responsible for developing innovative regulatory strategy and assuring this regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring those regulatory submissions are on time and high quality
• 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
• Manage new applications for biologics through planning, preparation, submitting, reviewing support for product dossiers
• Lead the license maintenance with annual reports (US, Canadian NDC and YBPR, license and renewals) and site renewals (ex. Japan Accreditation)
• Oversee 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 achieve implementation of appropriate regulatory strategies with regards to the financial impact and all identified risks

About you

Experience:

• 3+ years of experience in a regulatory function within a matrix environment
• Business acumen expert knowledge
• Knowledge and experience of key Health authorities as EU, FDA, and global regulations is a plus
• Biological products, vaccines or small molecules experience is preferred

Soft skills:

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and different functions
• Demonstrated ability to effectively influence leaders and team members to work successfully on project teams
• Strong organization and communication skills within a matrixed organization
• Success in developing and managing a strategy and planning process
• Track record with workforce capacity planning / productivity

Technical skills:

• Proficiency in Microsoft Office Suite

Education:

• Bachelor or ideally Master’s scientific, healthcare or life sciences degree
• RAC certification is a plus

Languages: Excellent written and verbal communication skills in English

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
• Work from an "Office of the Year 2020" finalist office
• 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
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.