Lead Regulatory Scientist
4 weeks ago
CK Group have an excellent opportunity for a Lead Regulatory Scientist to join a world-leading global pharmaceutical company on a 12-month contract basis. Hybrid working at our client's modern Welwyn Garden City offices is desirable but this position canalso be done fully remotely.
This role is deemed to fall outside IR35.
**Rate**:
£600-£750 per day (Ltd/ Umbrella)
**In this senior regulatory role you will**:
- Lead Regulatory Affairs activities for products throughout the drug development process, (Clinical Trial Applications, National Licensing Applications, Marketing Authorisations).
- Be responsible for regulatory management of marketed medicines in the UK and innovative development products that will be submitted post EU exit.
- Provide strategic expertise to cross-functional teams.
- Develop, improve and maintain procedures to ensure compliance to evolving regulations.
- Represent UK Regulatory Affairs (DRA) both externally, internally at EU/HQ level, and in cross-functional teams to support the business.
**Your Background**:
- A University Degree in a scientific field.
- Strong proven Regulatory Affairs experience within a pharmaceutical company.
- Proven successful interactions with health authorities, both through face to face meetings as well as through MAA procedures
- Successful track record in Regulatory Affairs, including stakeholder management and experience of UK or EU management of Marketing Authorisations and CTAs
- Right to work in the UK is essential
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55163 in all correspondence.
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