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Vaccines - Regulatory Product Manager Europe

date posted 08/05/2022
contract type Full time
job id R2652109
location Marcy-l'Etoile;

Vaccines - Regulatory Product Manager Europe

About the job

Your Mission

Join the Sanofi Pasteur team for a Vaccines - Regulatory Product Manager Europe role!

You will be accountable for managing products under development and/or marketed products. You will be reporting to the Regulatory Product Leader - Europe.   

Our Team

At Sanofi Pasteur, we’ve been committed for more than 100 years to extending the life-saving power of vaccination as broadly as possible. Our history is grounded in life science pioneers who discovered how infectious diseases work. They unlocked the public health potential of vaccination and developed efficient mass production methods to ensure the broadest access to vaccines.

Our portfolio of vaccines offers protection against a wide range of infectious diseases for people around the world. Ranging from yellow fever, rabies and diphtheria, to Haemophilus influenzae type b, polio, pertussis, tetanus, hepatitis A and B, meningitis, influenza … to name a few.

Main responsibilities

  • Develop Europe regulatory strategy and provide regulatory expertise within project/product teams for products under development and/or marketed products as required
  • Define, Coordinate and contribute to the preparation of CTA, IMPD, DSUR and major regulatory submission (e.g. MAA) and/or any type of responses document to Europe Health Authority (HA) questions with the stakeholders (Non-clinical, Clinical, Medical, Pharmacovigilance, etc.)
  • Lead and coordinate interactions with European HA: Scientific advices (including briefing package preparation), oral explanations and pre-submission meetings
  • Follow regulatory changes, competitor's status and assess potential impact on daily activities and project strategy
  • Provide regional inputs, updates, and reviews of the GRPS as needed. Ensure maintenance and compliance of regulatory activities for development and marketed products

About you

  • 5+ years of experience in the pharmaceutical industry
  • Demonstrated experiences in regulatory affairs 
  • Comprehensive knowledge and operational expertise of the EU regulations
  • Comprehensive knowledge of US regulations and worldwide key regulations
  • Ability to work with multifunctional and multicultural teams 
  • Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor
  • Ability to communicate effectively and efficiently with other functional departments in the
  • business
  • Good relationship ability
  • Ability to resolve issues and proactivity
  • Physician, Pharmacist, Veterinarian or Life Sciences Bachelor’s Degree
  • Fluent English

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, disability, or gender identity.

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

#LI-EUR

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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