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Regulatory Scientist, Global Regulatory Affairs

Employer
CK Group
Location
Allschwil
Salary
70-90 CHF per hour (all incl)
Closing date
19 Aug 2021

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Sector
Regulatory Affairs
Contract Type
Contract
Hours
Full Time
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Job Details

CK QLS are recruiting for a Regulatory Scientist to join a global pharmaceutical company at their site based just outside for Basel, in Allschwil. This role is offered on a 9 month maternity cover role.

Regulatory Scientist, Global Regulatory Affairs Role:

The main purpose of the role will be to provide support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy.

Key responsibilities will include:
  • Participating in global regulatory team meetings as appropriate.
  • Advising the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned.
  • Liaising with Regulatory Agencies and Local Operating Companies.
  • Assisting in the preparation of meetings with Regulatory Agencies.

Further responsibilities will include:
  • Reviewing clinical trial plans and protocols and ensure alignment with regulatory requirements.
  • Advising team in required documents and submission strategies (in collaboration with LOCs as appropriate) including Health Authority Submissions (e.g. Briefing Books, Scientific advice packages, Marketing Authorization Applications (MAAs), New Drug.
  • Applications (NDAs) or equivalent regional or national documents).

Your Background:
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
  • University degree - Medical or Paramedical (Pharmacy, Biology, Veterinary etc.) or equivalent by experience.
  • Previous experience working in is regulatory affairs, desirable.
  • Understanding of the drug development process and regulatory submission and approval process.
  • Knowledge of the regulatory environment, guidelines and practices of region.
  • Previous experience in Pulmonary Hypertension / Orphan Diseases would be advantageous.

This is an excellent opportunity to join a global pharmaceutical company and gain invaluable experience.

Apply:
For more information or to apply for this Regulatory Scientist, Global Regulatory Affairs position, please contact Jocelyn on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 51208.

It is essential that applicants hold entitlement to work in Switzerland.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Find Us
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB
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