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Regulatory Affairs Senior Manager

Employer
CK Group
Location
Cambridge
Salary
Up to £48.61 per hour PAYE
Closing date
21 May 2021

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Sector
Regulatory Affairs
Contract Type
Contract
Hours
Full Time

Job Details

CK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company at their site based in Cambridge on a on a contract basis for 12 months.

Salary:
Up to £48.61 per hour PAYE

Regulatory Affairs Senior Manager Role:
  • Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders, may manage one or more regional leads or support roles Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications)
  • Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
  • Leads development of regional regulatory documents and meetings in accordance with GRT strategy Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and pediatric plan)
  • Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
  • Manages regional label negotiation activities with minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives Co-ordinates company responses to requests from regulatory authorities, e.g Response to Questions (RTQs) Communicates regulatory strategies as appropriate such that expectations are understood.

Your Background:
  • Working with policies, procedures and SOPs
  • Experience with national legislation and regulations relating to medicinal products
  • Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
  • Understanding of drug development Scientific / Technical Excellence
  • Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage

Company:

Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

Location:

This Regulatory Affairs Senior Manager role will be based at our client’s site in Cambridge.

Apply:

For more information, please contact Dennis on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 50639.

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

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