CK Group are recruiting for a Regulatory Clinical Trial Submission Manager to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis for 12 months.
Our client is one of the world\'s leading research-based pharmaceutical companies and is part of a global family of companies.
This Regulatory Clinical Trial Submission Manager role will be based at our clients site in High Wycombe, Buckinghamshire.
£32.25 per hour PAYE / £43.33 per hour LTD.
Regulatory Clinical Trial Submission Manager Role:
- Ensure that the required regulatory intelligence is in place to comply with country-specific requirements.
- Lead a cross-functional team that will compile, publish and produce Clinical Trial Authorisation Applications and associated CTA lifecycle submissions (e.g. Health Authority responses, amendments, etc.).
- Be responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
- Ensure that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.
- If Clinical Research Organisations are contracted to handle some (or all) aspects as outlined above, you will be responsible for liaising with and overseeing CRO staff, as required.
- Bachelor\'s degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology.
- Experience within regulatory affairs in the pharmaceutical industry and 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, prioritisation, 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.
For more information or to apply for this Regulatory Clinical Trial Submission Manager position, please contact CK Group, quoting job ref 49301.
It is essential that applicants hold entitlement to work in the UK.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Julie Marshall
- Phone: 01438 723 500
- Reference: 49301
- Posted: 18th November 2020
- Expires: 16th December 2020