Senior Manager Regulatory Affairs - MHRA

Apsida Life Science; Greater London; Presencial; GBP 60.000 - 80.000; Jornada completa

Descripción de la vacante

Apsida Life Science is seeking a Senior Regulatory Affairs Manager to support their UK portfolio. The role involves managing a small team and acting as the primary Regulatory contact for an identified therapeutic area.

The ideal candidate will have significant experience with UK regulatory processes, proven line management experience, and a degree in Life Sciences or a related field. Responsibilities include developing regulatory strategies and ensuring compliance with UK legislation.

Formación

• Significant experience within UK regulatory processes and MHRA interactions.
• Must have proven, recent line management experience.
• Experience managing regulatory submissions and lifecycle activities.

Responsabilidades

• Acts as the primary Regulatory contact for identified therapeutic area.
• Develop regulatory strategies and timely submissions to the MHRA.
• Ensure compliance with UK legislation for medicines, clinical trials and PIPs.

Conocimientos

UK regulatory processes

MHRA interactions

Line management experience

People skills

Educación

Degree in Life Sciences or a related field

Descripción del empleo

Apsida Life Science are currently partnering with a global biopharmaceutical company recognised for developing innovative medicines that address complex and serious diseases. The organisation combines strong scientific expertise with a patient-first approach, focusing on improving standards of care through breakthrough therapies and close collaboration with healthcare systems.

They are seeking a Senior Regulatory Affairs Manager to support their UK portfolio and being responsible for managing a small team.

Responsibilities

• Acts as the primary Regulatory contact for identified therapeutic area.
• Develop regulatory strategies and timely submissions to the MHRA, as well as developing and maintaining a strong relationship with MHRA/local pharma trade associations.
• Act as Regulatory liaison with Area and local UK cross functional teams to ensure UK strategies align with global strategies, whilst maintaining compliance with local regulations.
• Ensure compliance with UK legislation for medicines, clinical trials and PIPs.
• Responsible for line managing a small team.

Requirements

• Degree in Life Sciences or a related field.
• Significant experience within UK regulatory processes and MHRA interactions.
• Must have proven, recent line management experience.
• Experience managing regulatory submissions and lifecycle activities.
• Highly developed people skills and a positive, can-do attitude.

If you are interested in learning more, please reach out to Geneva Jones at Apsida Life Science:

www.apsida.co.uk

[phone]