Inserat vom Sonntag, 16. Dezember 2018

Regulatory Affairs Team Leader

Kelly Scientific GenèveGeneve
  • Geneve
  • Personalvermittler
  • Festanstellung, 100%
  • Führungs­position

Kelly Scientific is looking for a REGULATORY AFFAIRS TEAM LEADER    
We are currently looking for an experienced Regulatory Affairs  Team Leader who leads key activities...

Regulatory Affairs Team Leader

Kelly Scientific is looking for a REGULATORY AFFAIRS TEAM LEADER    
We are currently looking for an experienced Regulatory Affairs  Team Leader who leads key activities...
Kelly Scientific is looking for a REGULATORY AFFAIRS TEAM LEADER    
We are currently looking for an experienced Regulatory Affairs  Team Leader who leads key activities of the Therapeutic Area and International team. You are responsible for the definition and implementation of regulatory strategies based on the good knowledge and appropriate interpretation of guidelines and directives. 

Based in Geneva, you report to the Head of Regulatory Affairs and your responsibilities include:
 

  • Lead the Therapeutic Area 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
We are looking for a customer- and service-oriented person who brings experience in working with a wide variety of stakeholders across diverse teams both internally and with external partner companies. 

Furthermore, your profile meets the following criteria:
 
  • 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
If you think your profile fits to this position, don't hesitate to apply online and it will be a pleasure for us to consider your interest.
 

Your contact at Kelly Scientific:

Mathilde DROMARD
Consultant Professional Staffing Life Science and Deputy Manager 

 
 

Rue du Rhône 114 1204 Genève

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