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Job Details

Global Program Regulatory Manager

Company: CTC Resourcing Solutions
Location: Basel
Reference: 895781-P
Closing Date: 16 Mar 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Our client is a global pharmaceutical company looking for a Global Program Regulatory Manager for a 6 months contract based in the Basel area, Switzerland. The ideal candidate should have previous experience in Regulatory Affairs with proven experience in planning and compilation of Clinical Trial Applications across Europe and Asia.

Requirements:

Main Responsibilities

  • Provide support to the team in planning and tracking meetings and deliverables to support regulatory submissions
  • Support regulatory Lead in the preparation and submission of global original Clinical Trial Applications (CTA)
  • Independently prepare maintenance regulatory submission packages such as substantial amendments, DSURs, Investigator Brochures, Clinical Study Reports, etc.
  • Support the coordination of teams in the preparation of Health Authorities responses to submissions
  • Interpret and understand regulatory implication of non-clinical and clinical data. Provide strategic regulatory input into selected clinical trials documents such as protocols, IBs, DSURs

Qualifications and Experience

  • +4 years regulatory experience including proven experience in:
  • Planning and compilation of CTAs with special focus on European submissions, including addressing Health Authorities questions. Experience with small molecules and biologicals and the review/approval process in Asia is an additional asset
  • Science based BS or MS
  • Excellent project management skills with proven ability to manage several projects and competing priorities
  • Strong interpersonal, communication, negotiation and problem solving skills.
  • Fluency in English (written and spoken)
  • Relevant working/residency permit or Swiss/EU-Citizenship required

If you think your profile matches this position and want to take a challenge in your career don’t hesitate to apply.

Apply for this job: Global Program Regulatory Manager

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 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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