Regulatory CTA Submissions Manager

Location
High Wycombe
Salary
£48 PAYE / £65 Umbrella
Posted
15 Mar 2021
Closes
14 Apr 2021
Ref
50105
Contact
Lucy Stendall
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Management
CK Group are recruiting for a Regulatory Clinical Trial Application Submission Manager to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis for 12 months.

Company:

Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies.

Location:
This Regulatory Clinical Trial Application Submission role will be based at our clients site in High Wycombe, Buckinghamshire although there could be flexibility for home working.

Salary:
£48 per hour PAYE / £65 per hour Umbrella.

Regulatory Clinical Trial Application Submission Manager Role:
  • This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).
  • The Regulatory CTA Submission Manager will ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.).
  • The CTA Submission Manager is responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs. The CTA submission manager ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.

Your Background:
  • Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology.
  • Ideal candidate would possess a minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industry. An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required.
  • Must have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur.
  • Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency).
  • Ability to lead complex projects and a high degree of problem solving capability required. Must have a high level of Self-Awareness and Adaptability and strong impact and influencing skills.

Apply:
For more information or to apply for this Regulatory CTA Submissions Manager position, please contact CK Group, quoting job ref 50105.

It is essential that applicants hold entitlement to work in the UK.

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