Technical Regulatory Specialist

£85 - £90 per hour
  1. Interim/Contract
Basel
  1. Regulatory Affairs, Operations
Posted: 12/02/2020
BBBH13427

This vacancy has now expired. Please see similar roles below...

Hobson Prior are currently seeking a Technical Regulatory Specialist to join a Swiss global healthcare organisation who are focused on offering medical solutions in order to transform patients' lives. This position will be on a contract basis, located in Basel.

Job Responsibilities:

  • Deliver expert knowledge on regulatory requirements and environment for International countries.
  • A strong partner to affiliates, finding innovative solutions and challenging the status quo.
  • In partnership with PDR Emerging and Regional Affiliates Support Team, develop and execute objectives and plans towards aligning one global regulatory voice/outlook to affiliates.
  • Communicate with global team to ensure technical CMC requirements in International countries are integrated into the global development plans.
  • Work in close collaboration with the affiliate DRA's, and PDR Emerging and Regional Affiliates Support Team to build regulatory strategies, ensure the affiliate voice is represented within headquarters.
  • Contribute to planning of Health Authority Meetings.
  • Contribute to response to Health Authority questions and provide authoring support as needed.
  • Be a key member of the TRT (Technical Regulatory Team) to discuss and align on regulatory activities.
  • Participate in projects and initiatives outside of the core scope of International Regulatory Manager responsibilities.

Key Skills:

  • Flexible & strategy-thinking mindset, good communications skills.
  • Understand current and historical regulatory environment and its impact on assigned products
  • Fluency in written and spoken English.

Requirements:

  • A minimum 3 years of experience in International Drug Regulatory Affairs.
  • Experience with Module 3.
  • Scientific background needed: Education (BSc/MSc) in biology, biochemistry.
  • Good practical experience of health authority's management and global regulatory processes.
  • Experience in a global matrix environment (dealing with affiliates and internal stakeholders globally).

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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