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Job Details

Freelance Senior Regulatory Affairs Manager – 50%

Company: CTC Resourcing Solutions
Location: Baden-Württemberg area, Germany
Reference: 895155-P
Closing Date: 11 Dec 16
Type: Temporary
Salary (£): Competitive
Benefits:

Job Summary:

You will set up and oversee Regulatory procedures, processes and systems based on your long-term experience and expertise as a Freelance Regulatory Affairs Manager.

Requirements:

Reference Number:         895155-P

Type of placement:         Freelance, 50%

Location:                        Baden-Württemberg area, Germany

 

 

Main Responsibilities:

  • Set up and oversee  Regulatory procedures, processes and systems
  • Provide support and lead scientific team on all regulatory and vigilance topics.
  • Provide expertise with setting up the required studies and registration in Europe
  • Responsible of designated regulatory projects and compliance with respective deadlines
  • Responsible for planning, leading and implementing regulatory submissions
  • Main point of contact with Regulatory Affairs and Health Authorities, 3rd parties, distribution partners
  • Compiling and updating regulatory dossiers according to international guidelines (EU, FDA)
  • Administration of regulatory documentation and ensuring the traceability of regulatory history
  • Keeping up to date with the latest regulatory requirements

 

Qualifications and Experience:

  • University degree in life science (ideally in pharmaceutical sciences), or a medical degree
  • Minimum 5-7 years of relevant experience in Regulatory Affairs in Diagnostics, Biologics , and /or Pharma
  • Knowledge and experience of regional regulatory processes
  • Practical experience of successfully managing Health Authority interactions on a Regional Basis
  • Knowledge of drug discovery, development, manufacturing and marketing
  • Commitment to performance measures of time, cost and quality
  • Self-assertion, capacity for teamwork
  • Creative, solution-oriented work approach
  • Strategic thinking and acting
  • Willingness to travel
  • Fluency in written and spoken English

 

Apply for this job: Freelance Senior Regulatory Affairs Manager – 50%

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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