Regulatory Affairs Manager

  • Salary: Competitive
  • REF Number: 00052733
  • Consultant: Ashleigh Williamson
  • Contact: 01438 842978
  • Date Published: 24.03.2022
  • Closed Date: 11.04.2022
  • Industry: Pharmaceutical
  • Location: Hatfield, Home Counties
  • Functional Expertise: Regulatory Affairs

CK Group are recruiting for a Manager of Regulatory Affairs to join a Japanese Global Pharmaceutical company. Working from home, flexibility could be available.

Rewards:

  • Competitive Salary
  • Up to 15% Bonus scheme (performance based)
  • Private healthcare available
  • Dental Insurance
  • Life Assurance
  • Attractive Pension scheme available
  • Payment of 2 Subscriptions a year
  • Eyecare vouchers
  • Flexible remote working is available

The company:

Global Pharmaceutical company,that focusses on Neurology and Oncology with blockbuster drugs currently in progress.

Highlighted responsibilities of Manager of Regulatory Affairs:

  • Be responsible for supporting some key development compounds in the Neuroscience areas.
  • Lead for early phase compounds targeting rare neurological conditions, design of clinical development programmes will be an important part of the role.

  • Contact with clients and external vendors and troubleshooting routine client inquiries. Mayrepresent the organisation as a prime contact for technical matters of significant complexity.

  • Develops and implements regulatory strategy for own functional area and region. Contributes to, and implements, strategy for interactions and negotiations with health authorities.

Your background:

  • A relevant Life Science degree.
  • Proven experience with EU and/or UK regulatory Process and environment including clinical trials regulatory strategy experience and strong strategic thinking skills.

  • Experience negotiating and liaising with regulatory authorities, both verbally and in writing.

  • Excellent written and verbal communication skills.
  • Must be able to operate in a complex environment and think on their feet.
  • Experience in Neurology therapy area is advantageous.

Entitlement to work in the UK is essential. Please quote job reference 52733.

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