Regulatory Affairs Partner

CK Group- Science, Clinical and Technical; Welwyn Garden City; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A global pharmaceutical company in Welwyn Garden City is seeking a Regulatory Affairs Partner to leverage regulatory and scientific expertise. The role entails ensuring compliance with UK regulations while leading strategic initiatives. Applicants should hold a degree in Life Sciences and have extensive experience in UK Regulatory Affairs, including managing submissions post-Brexit. This position allows for hybrid working, making it ideal for candidates looking for flexibility in their work environment.

Qualifications

• Educated to degree level or above in Life Sciences or a related field.
• Extensive experience in UK focused Regulatory Affairs.
• In-depth knowledge of UK and EU regulatory requirements.

Responsibilities

• Collaborate with the business to ensure compliance with UK regulations.
• Lead foundational work to solve complex regulatory issues.
• Serve as the primary contact with the MHRA.

Skills

Regulatory Affairs expertise

Cross-functional collaboration

Strategic advisory

Regulatory compliance

Education

Degree in Life Sciences or related field

Job description

CK Group are recruiting for a Regulatory Affairs Partner to join a global pharmaceutical company putting patients at the heart of what they do. The role will be based in Welwyn Garden City on a permanent basis.

Location

The role is based in Welwyn Garden City and offers hybrid working.

Role

You will leverage your regulatory and scientific expertise to shape and drive strategic initiatives for the UK Regulatory group.

• Collaborate with the wider business to translate the constantly evolving requirements of the UK regulatory environment into policies, procedures, solutions, and strategies that ensure compliance and maximize the value for patients.
• You will work across Clinical Trial Applications, National Licensing Applications, Early Access to Medicines Applications and National components of medicines authorization via the European Centralized procedure.
• Be part of the team serving as the primary contact with the MHRA.
• Lead foundational work and partner with the business to solve complex regulatory issues.

Your Background

• Educated to degree level or above in Life Sciences or a related field.
• Extensive experience in UK focused Regulatory Affairs.
• In-depth knowledge and experience of UK and EU regulatory requirements and procedures and experience in providing strategic and technical advice.
• Proven experience managing UK submissions post-Brexit.
• A proven track record of developing, implementing, and communicating regulatory strategies.
• Experienced in effective cross-functional collaboration at both local and global levels, as well as the capability to negotiate and influence externally.

Apply

For more information, or to apply for this Regulatory Affairs Partner position please contact Mary Bolt on (phone number removed) or email (url removed). Please quote job reference (phone number removed) in all correspondence.

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