Regulatory Affairs Team Leader

GenèveFixeChimie, Pharma, Biotechnologie2019-05-01Master / Université
We are recruiting on behalf of our client a:

Regulatory Affairs Team Leader

Your Challenge

  • Lead the TA and International team (5 direct reports and up to 8 team members)
  • Contribute to the definition and the implementation of regulatory strategies to support/maintain registrations and coordinate operational activities of the team
  • Coordinate life cycle activities / maintenance of existing prodiuct licenses
  • Coordinate dossiers submission accodinng to the defined timelines (renewals, variations, responses to HA questions
  • Ensure compliance of the portfolio with legal requirements
  • Conduct risk assessments and set-up mitigation plans
  • Cooperate with internal stakeholders (marketing, Commercial, Global Drug Safety...) to ensure alignment on strategies
  • Be responsible for the management and development of staff by overseeing recruitment and training, evaluating performance, defining and assigning responsibilities, providing opportunities for career development

Your Profile

  • Degree in Life Sciences, Pharmaceutical Sciences or Medical
  • 8 to 10 years of experience in Regulatory Affairs
  • Ability to perform comprehensive gap assessments and build effective regulatory strategies (Good knowledge and appropriate interpretation of guidelines, directives etc...)
  • Self-assertion, creative and solution-oriented work approach
  • Accuracy, flexibility, open minded, team spirit, organised, autonomous
  • Strategic thinking and acting, entrepreneurship skills
  • Experience in people management and development
  • Excellent communication and negotiation skills at all levels, diplomacy and respectful behavior
  • Discretion in the handling of confidential information
  • Good command of French and English both in written and oral conversation

Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -032019-295299