Head of Regulatory Affairs

Head of Regulatory Affairs

Sanofi

Østerbro, Denmark

About the Opportunity

Join Sanofi’s European Regulatory Affairs team as a Head of Regulatory Affairs, Denmark.

We are looking for an experienced Regulatory Affairs professional with proven ability to lead our Danish team whilst providing valuable strategic input on a regional level.

About growing with us

In this role you will….

  • Manage the Regulatory Affairs (RA) function: define local RA priorities and lead, motivate and develop the local RA team
  • Contribute to European RA strategies by providing proactive RA support respecting the local RA requirements and business needs
  • Ensure advice and input is provided to local business strategies with regards to regulatory feasibility, requirements and timelines
  • Manage the local RA budget and maintain optimal resource capacity
  • Take active part as member of the Medical Regulatory Pharmacovigilance Quality (MRPQ) Council and Country Leadership Team
  • Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national and European regulations
  • Actively follow the development and emergence of new regulatory requirements and assess their impact on the existing products and in development
  • Act as the primary interface between the company and local regulatory authorities
  • Ensure Sanofi’s active participation in local trade associations to influence the regulatory environment in accordance with the company strategy
  • Give Input to Global RA for drug development with regards to local needs (labelling, clinical trials, access etc.)

About you

Qualifications/Education & work experience

  • Education: Physician, Pharmacist, Veterinarian or a Life Sciences Graduate
  • 5+ years of proven Regulatory Affairs experience from the pharmaceutical or Life Sciences industry
  • Proven leadership and people management experience
  • Excellent knowledge of the Danish and European regulatory legislation, procedures and guidelines governing pharmaceutical products
  • Track record of building excellent relationships with the Danish Medicines Agency (DKMA) and other regulatory agencies
  • Ability to demonstrate diplomacy and assertiveness in communication with internal and external partners
  • Strong analytical, problem solving and project management skills
  • Excellent negotiation and interpersonal communication skills
  • Oral and written fluency in Danish and English

Apply Now

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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