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Job Details

Regulatory Affairs Manager

Company: CTC Resourcing Solutions
Location: Basel Area.
Reference: 896084-P
Closing Date: 14 Jan 19
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

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

Requirements:

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

Apply for this job: Regulatory Affairs Manager

Contact Information:

Address:  Head Office
Münchensteinerstrasse 41
4052 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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