Regulatory Affairs Manager

Location
Uxbridge
Salary
Up to £42.59 ph PAYE
Posted
14 May 2021
Closes
13 Jun 2021
Ref
50638
Contact
Dennis Beltman
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Management
CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 6 months.

Salary:
Up to £42.59 ph PAYE

Regulatory Affairs Manager Role:
  • Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
  • Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
  • Provides content guidance for regional regulatory documents and meetings in accordance with strategy
  • Manages in the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
Your Background:
  • 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 Uxbridge, Greater London.

Apply:
Please quote reference 50638.

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