Regulatory Affairs Manager

GenèveFixeChimie, Pharma, Biotechnologie2019-03-21Master / Université
We are currently looking for an experienced Regulatory Affairs Manager with focus on the EurAsian Economic Union and APAC markets. You are responsible for the creation and implementation of regulatory strategies based on the good knowledge and appropriate interpretation of guidelines and directives.

Regulatory Affairs Manager

Your Responsibilities

  • Keep up to date with the latest regulatory requirements with the focus on the regulatory strategy in EurAsian Economic Union and APAC.
  • Act as Point of Contact between Regulatory Affairs of the partner company, local regulatory representatives of OM Pharma and corporate or regional stakeholders
  • Maintain the assigned Regulatory Databases according to internal guidelines
  • Manage the response to Health Authority questions / requests for information
  • Plan all regulatory activities with the assigned partner companies and ensure timely execution
  • Ensure compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Regulatory Affairs such as the Therapeutic Groups, Labelling, Reg Ops and CMC
  • Responsible for ensuring successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the assigned territory
  • Drive the approval process.
  • Support GMP inspections of manufacturing sites by competent authorities (i.e. EAEU, Russia, Belarus, Kazakhstan and China inspections)
  • Manage product label information development in accordance with the regional requirements
  • Cooperate with internal stakeholders such as Global Drug Safety, Quality and other departments to ensure compliance and alignment with agreed partner support levels

Your Profile

  • Degree in Life Sciences, Pharmaceutical Sciences or Medical
  • 4 to 6 years of experience in Regulatory Affairs in the EurAsian Economic Union and APAC markets
  • Good command of French, English and fluency in Russian both in written and oral conversation
  • Ability to analyze the regulatory requirements (particularly EAEU/APAC regulatory, quality and safety guidelines), perform comprehensive gap assessments and build effective regulatory strategies

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La référence de cette offre est JN -032019-295299