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Regulatory Affairs Senior Manager

Cambridgeshire CB4   •  Contract/Temporary, Full time


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: (Oncology / General TA)
? 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.

Please quote reference 50639.
It is essential that applicants hold entitlement to work in the UK.


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Dennis Beltman
  • Phone: 01438 870027
  • Reference: 50639
  • Posted: 9th September 2021
  • Expires: 7th October 2021

CK Group

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