Regulatory Affairs Manager

Reference Number: 896084-W
Type of placement: Contract
Location: Switzerland, North West

Introduction:

For one of our clients, a multinational pharmaceutical company, we are currently looking for a Regulatory Affairs Manager.

Main Responsibilities:

  • Provide regulatory strategy for the MENA region;
  • Works with some independence under limited supervision to provide strategic and operational regulatory direction;
  • Lead and coordinate timely and high quality preparation of all necessary supporting documentation by internal or external experts for MENA license renewals, MENA variations (except CMC-related variations), PSUR submissions for assigned registered products;
  • Interact with the MENA and other Rest of World Health Authorities to solve regulatory issues related to assigned registered products;
  • Represent Regulatory Affairs (RA) in negotiations with HA in MENA;
  • Provide prompt and complete responses to regulatory relevant queries from various stakeholders relating to assigned brands;
  • Coordinate archiving of submitted registration dossiers and other relevant Health Authority communications;
  • Evaluate and review regulatory parts of contracts and CRO quotations.

Qualifications and Experience:

  • Degree in life science preferable and at least 6 years experience in regulatory affairs;
  • Sound experience with MENA (Middle East and North Africa);
  • Ability to work in multicultural environment;
  • Excellent communication and interpersonal skills;
  • Accuracy and good project management skills;
  • Excellent command of spoken and written English;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

 

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