associate director/manager regulatory affairs in Geneve

posted
contact
Clémentine Dupuis, Geneva Professionals Health Care & Life Sciences
job type
permanent
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job details

posted
location
geneve, geneva
sector
Life Sciences
job type
permanent
reference number
10842
contact
clémentine dupuis, geneva professionals health care & life sciences
phone
058 201 54 40
apply now

job description

We are looking for an Associate Director/Manager Regulatory Affairs for one of our Pharmaceutical client located in Geneva.

Duties and Responsibilities:

  • Provide global leadership regarding management of submission related documents, regulatory data, and archiving for Biosimilars
  • Develop, supervise, and manage the portfolio and submission strategy of Biosimilar dossiers and submissions
  • Contribute to and support strategies to implement technologies supporting all current and future authorities’ requirements
  • Ensure Biosimilar data governance across systems
  • Manage regulatory submission process through to approval, including management and coordination of all regulatory documentation
  • Mentor and train Regulatory professionals

Requirements 

  • At least 10 years of experience
  • University degree in Life Sciences or related discipline
  • Experience in the pharmaceutical industry and international regulatory affairs
  • Experience in managing international or regional regulatory submissions and in leading regulatory agency interactions
  • Profound knowledge of preparation and coordination of regulatory strategy plans
  • Excellent communication, organizational, and interpersonal skills
  • Ability to think strategically and to lead and work in teams
  • Willingness to travel 25% of time
  • Fluency in English, additional languages would be asset

If your profile corresponds closely, please do not hesitate to send us your CV, latest certificates and the date of your availability. Only online applications will be considered. We look forward to your application. A valid Swiss work permit OR Swiss or EU-25/EFTA citizenship is required.