Regulatory Affairs Director — CNS Biotech Leadership

The RFT Group; Manchester; On-site; GBP 90,000 - 120,000; Full time

Job summary

A clinical-stage biotech company in Manchester is seeking a Regulatory Affairs Director to lead and oversee the regulatory strategy for innovative mental health therapies. The ideal candidate will have over 8 years of experience in regulatory affairs, specifically within clinical development, and must demonstrate a proven track record in managing clinical trial applications. This role involves collaboration with internal teams and regulatory agencies to ensure compliance and facilitate successful product launches. A background in psychiatry or neurology is advantageous, and a relevant degree is required.

Qualifications

• 8+ years of RA experience in biotech, with focus on clinical development.
• Experience in US, EU, and UK regulatory dossier preparation.
• Experience leading regulatory interactions with major agencies.
• Knowledge of global regulatory guidelines and industry best practices.

Responsibilities

• Manage clinical trial applications and ensure compliance.
• Oversee submissions from regulatory vendors for quality standards.
• Provide RA review of essential clinical documents.
• Act as RA representative on product development teams.

Skills

Regulatory Affairs experience

Clinical trial management

Technical writing

Communication skills

Team collaboration

Education

Bachelor's or advanced degree in Life Sciences

Tools

Microsoft Office Suite

Adobe Acrobat

Job description

A clinical-stage biotech company in Manchester is seeking a Regulatory Affairs Director to lead and oversee the regulatory strategy for innovative mental health therapies. The ideal candidate will have over 8 years of experience in regulatory affairs, specifically within clinical development, and must demonstrate a proven track record in managing clinical trial applications. This role involves collaboration with internal teams and regulatory agencies to ensure compliance and facilitate successful product launches. A background in psychiatry or neurology is advantageous, and a relevant degree is required.