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Job Details

DRA Project Manager

Company: CTC Resourcing Solutions
Location: Basel
Reference: 895672-P
Closing Date: 23 Mar 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

For one of our clients, we are currently looking for a DRA Project Manager.

Requirements:

Reference Number:         895672-P
Type of placement:         Contract, 12 months
Location:                        Switzerland, Basel area

Main Responsibilities:

  • Acquire and maintain an overview of relevant regulatory requirements and guidelines
  • Assume EU regulatory responsibility for individual tasks on assigned projects, such as
    • creation and finalization of key regulatory documents (IMPD)
    • ensuring submission to HA (EU) scientific advice packages, PIPs, Orphan applications, Module 1 documents for EU
    • support for global submissions (MAA, etc.), variations.
  • Represent DRA (together with the Global DRA-PL) in lifecycle-, CT- and other project related meetings and other governance related meetings
  • Collaborate closely with the Global US-based DRA partner for regulatory considerations on assigned projects
  • Support Global DRA-PL on creation and finalization of strategic DRA documents such as Regulatory Functional Plan

Qualifications and Experience:

  • Bachelor’s Degree, in life sciences, medicine, pharmacy or equivalent
  • Good knowledge of regulatory legislation and guidelines
  • Good understanding of the regulatory aspects at various stages of development, from EIM to post-approval activities
  • Familiarity with clinical trial methodology and statistics
  • Capable of working independently as well as effective team player
  • Ability to work within tight timelines with very good project management skills
  • Excellent communication, interpersonal, negotiation and problem solving skills
  • Accuracy, reliability and diligence
  • Excellent in both written and spoken English
  • Relevant working/residency permit or Swiss/EU-Citizenship required

Apply for this job: DRA Project 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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