| Location: High Wycombe | Salary: £60 - £80 per hour |
| Sector: Pharmaceuticals | Specialism: |
| Type: Contract | Contact: Matt Henocq |
Regulatory Affairs Manager EMEA
Summary of current position to be filled:
A regulatory affairs professional who can support the regional regulatory strategy for products in the oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations.
Job Description
- Participate in global regulatory team meetings as appropriate
- Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
- Have an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic areas
- Act as back-up for contact with Regulatory Agencies as needed
- Draft cover letters for Regulatory Agency communication
- Assist in the preparation of meetings with Regulatory Agencies
- Liaise with LOCs, track and respond to queries in a timely manner
- Assist in development of processes related to regulatory submissions
- Draft and review some document content (depending on level of regulatory knowledge / expertise)
- Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
- Track dates of submissions and Regulatory Agency responses
- Ensure CTA submission packages are complete and available according to agreed timelines
- Review and approve clinical trial supply plans
- Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
- Assist with submission and acceptance of MAA
Requirements:
Education and experience
- University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- Experience in regulatory affairs
- Teamwork experience
Skills
- Project management skills
- Oral & written communication skills
- Organization & multi-tasking skills
Knowledge
- Knowledge of the regulatory environment, guidelines and practice of EMEA regions
Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website.
