Regulatory Clinical Trial Application Submission Manager

£55 - £60 per hour
  1. Interim/Contract
High Wycombe, Buckinghamshire
  1. Regulatory Affairs, Development
Posted:20/11/2020
BBBH15483

Hobson Prior are looking for a Regulatory Clinical Trial Application Submission for a world-wide pharmaceutical organisation who are determined to bring better health to patients. This position will be based in High Wycombe on a contract basis.

Job Responsibilities:

  • You will be accountable to ensure that the required regulatory intelligence is in place to comply with country-specific requirements.
  • You will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions.
  • Responsible for interactions with Health Authorities and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
  • You will be ensuring that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.
  • If Clinical Research Organizations are contracted to handle some aspects as outlined above, the submission manager will be accountable for liaising with and overseeing CRO staff, as required.

Key Skills:

  • Strong communication skills, as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur.
  • 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.
  • Must have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organization.
  • Must have strong project management skills.

Requirements:

  • A bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required.
  • Knowledgeable with scientific terminology.
  • Ideally will need a minimum of 4-6 years' experience within regulatory affairs in the pharmaceutical industry.
  • You will have detailed knowledge of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements.
  • May have to work remotely from supervisor.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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