Skip to main content

This job has expired

Senior Manager, International Regulatory Affairs

Employer
CK Group
Location
London
Salary
£55000 - £70000 per annum
Closing date
12 Mar 2021

View more

Sector
Regulatory Affairs
Contract Type
Permanent
Hours
Full Time

Job Details

CK Group are recruiting for a Senior Manager, International Regulatory Affairs to join a biotechnology company home based on a permanent basis.

Senior Manager, International Regulatory Affairs Role:

The Senior Regulatory Manager is responsible for worldwide registrations and regulatory compliance throughout the lifecycle management of these marketing authorizations, under the oversight of the Global Head of Regulatory Affairs and Compliance and in collaboration with other Corporate functions as needed.

Key responsibilities will include:
  • Definition and implementation of regulatory strategies, organization and planning of regulatory affairs activities.
  • Leading or co-leading the preparation and filing of both first registration and post-approval packages, in alignment with internal functions (CMC, clinical, etc.) as well as external partners in International markets.
  • Follow-up of applications for marketing authorization, answers to questions from regulatory authorities and compilation of necessary supplements.
  • Drafting, follow-up and/or review of post approval applications (renewals, variations) to ensure the maintenance of marketing authorisations.
  • Supporting product launch, tenders, and interface with distributors on regulatory aspects.

Your Background:
  • Higher degree (M.Sc; Pharm.D or PhD) in Pharmacy or Life Sciences.
  • Minimum 8 years of experience in a similar role at international level, preferably in SMEs and/or in a consultancy role.
  • Substantial experience in obtaining and maintaining product licenses worldwide, particularly in International Markets; of particular interest APAC and LATAM regions.
  • Solid knowledge of regulations at European and international level.
  • Cross-functional leadership, strategic vision and negotiation skills.

Apply:
For more information or to apply for this Senior Manager, International Regulatory Affairs position, please contact CK Group, quoting job ref 49813.

It is essential that applicants hold entitlement to work in the UK.

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

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

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert