Global CMC Regulatory Consultant - Drug Development Leader

Scendea; Bishop's Stortford; Hybrid; GBP 70,000 - 90,000; Full time

Benefits offered by this job

Generous bonus program

26 days vacation plus additional days

Employer pension contribution

Private healthcare insurance

Access to Employee Assistance Programme

Employee Ownership Trust Scheme

Job summary

A global regulatory consultancy is looking for a Senior Consultant (CMC) to join their hybrid team. The role involves providing expert CMC development strategies and regulatory advice to clients. Candidates should have at least five years of relevant drug development and regulatory experience, ideally with FDA, EMA, or MHRA submissions. This position offers the chance to mentor junior staff and work on diverse projects within a supportive international environment, alongside generous benefits including a bonus program and professional development support.

Qualifications

• Relevant drug development experience of at least five years.
• Regulatory experience with FDA, EMA, or MHRA.
• Experience with a broad range of products including biologicals.

Responsibilities

• Provide strategic regulatory advice to clients.
• Lead consulting services and ensure project goals are met.
• Mentor and train members of the operational team.

Skills

Expertise in CMC development

Excellent verbal communication

Organizational skills

Regulatory negotiation

Education

BSc in a relevant field

Higher degree (MSc or PhD)

Tools

MS Office

Job description

A global regulatory consultancy is looking for a Senior Consultant (CMC) to join their hybrid team. The role involves providing expert CMC development strategies and regulatory advice to clients. Candidates should have at least five years of relevant drug development and regulatory experience, ideally with FDA, EMA, or MHRA submissions. This position offers the chance to mentor junior staff and work on diverse projects within a supportive international environment, alongside generous benefits including a bonus program and professional development support.