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Regulatory Affairs Manager

Cambridgeshire   •  £45.56 - £60.35 per hour  •  Contract/Temporary, Full time


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

Salary:
up to £45.56 ph (PAYE) or up to £60.35 ph (Umbrella / LTD)

Regulatory Affairs Manager Role:
? Manages in the development of the regional product label by collaborating with the Labeling Working Group.
? Supports regional label negotiation activities.
? Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment.
? Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
? Provides regulatory guidance on regional regulatory mechanisms to optimize product development.

Your Background: (Must have minimum of CTA and EU experience as training can be given)
? Knowledge of regulatory principles, working with policies, procedures and SOPs .
? Knowledge of relevant legislation and regulations relating to medicinal products.
? Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
? Knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country and International borders.

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 Manager role will be based at our clients site in Cambridge.

Apply:
Entitlement to work in the UK is essential. Please quote reference 51393.


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

  • Agency: CK Group
  • Contact: Heather Deagle
  • Phone: 0191 384 8905
  • Reference: 51393
  • Updated: 9th September 2021
  • Expires: 7th October 2021

CK Group

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