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Job Details

Regulatory Affairs Manager

Company: CTC Resourcing Solutions
Location: Zurich, Switzerland
Reference: 895059 - P
Closing Date: 02 Jan 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

You will provide support for the maintenance and compliance of a major existing marketing authorization in the US and Europe, successful submissions of variations, extension applications and line extensions according to the company strategy

Requirements:

 

Reference Number:          895059-P

Type of placement:          Permanent

Location:                         Switzerland, Zurich area

 

Purpose:

You will provide support for the maintenance and compliance of a major existing marketing authorization in the US and Europe, successful submissions of variations, extension applications and line extensions according to the company strategy

 

Main Responsibilities:

  • Responsible of designated regulatory projects and compliance with respective deadlines
  • Submission of MAA,  variations and maintaining existing marketing authorization mainly in the US and EU
  • Interaction with Regulatory Affairs and Health Authorities, 3rd parties, distribution partners
  • Cross-functional leadership of the project, Interfacing with other departments on a national and international level
  • Participation and contribution in meetings, such as Technical Team, Supply Chain, Life-Cycle-Management etc.
  • Compiling and updating regulatory dossiers according to international guidelines (EU, FDA, ICH)
  • Specialized tasks within the framework of Regulatory Affairs activities, e.g. support development projects with respect to regulatory requirements and responsibility for designated regulatory projects
  • Administration of regulatory documentation and ensuring the traceability of regulatory history (filing, archiving, database etc.)
  • Joint responsibility for meeting Regulatory Compliance
  • 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
  • Experience with EU MAA
  • Previous experience in managing a US FDA licensed product is a benefit
  • Good interpersonal, communication, negotiation and problem-solving skills
  • Strong analytical skills
  • Experience to work cross-functionally, experience to liaise with different stakeholders
  • Fluency in English both in writing and speaking
  • Self-assertion, capacity for teamwork
  • Creative, solution-oriented work approach
  • Strategic thinking and acting
  • Relevant working/residency permit or Swiss/EU-Citizenship required

 

 

Apply for this job: Regulatory Affairs 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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