• Location: Budapest
• Flexible working: 60% home, 40% office
• 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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Join us as Product Manager for Chemistry Manufacturing & Control (CMC) - Biologics and Vaccines and you will play a critical role in support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical biologic products. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. You will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and that regulatory submissions are on time and with high quality. Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management, also provide support for other CMC projects.

Main Responsibilities:

• New applications for biologics:
  • Plan/Prep/Submit/Review support for product dossiers
  • CTA / IND preparation and maintenance
• License Maintenance:
  • Recurrent filings: annual reports (US, Canadian NDC and YBPR, license and renewals)
  • Site renewals (ex. Japan Accreditation)
• Post Approval Supplements:
  • Regulatory strategy development
  • Preparing / Authoring / Review of Submissions – US, EU and Rest of World (ROW)
  • Technical Review of site supporting documents (CoA, declarations, SMF, MBR, SOPs)
  • Notify Reg Ops for publishing and dispatch
  • Response to Queries – US, EU and ROW
  • Interaction / liaise with EMA and EU member state on CMC topics
• Change Controls:
  • Change control assessments
  • Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments of the change
• Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations

About you:

Experience:

• +3 years regulatory experience or relevant industry experience
• Manufacturing, QA/QC experience
• Previous experience working in a fast-paced , matrix environment on multiple product lines
• Biological products, vaccines or small molecules experience is preferred

Soft skills:

• Excellent organizational and communication (written and verbal) skills
• Demonstrated ability to work successfully on project teams

Technical skills:

• Knowledge of FDA/EMA regulations is preferred
• Proficient in MS Word, Excel, PowerPoint, MS Project

Education:

• Minimum Bachelor’s degree in Life Sciences or related or equivalent
• RAC certification is desirable but not essential

Languages

• Strong command of spoken and written English is mandatory

#Sanofi #SanofiCareers #joinSanofi #jobopportunities #careeropportunities #sscjob #Sanofi_Budapest_Hub #Budapest #Regulatory #regulatoryaffairs #CMC #ProductManager #LI-EUR #LI-hybrid