Senior Regulatory Officer: CMC & Submissions Lead

Invenia Group; United Kingdom; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical consulting company in the UK seeks a Principal Regulatory Officer to ensure timely regulatory submissions and provide CMC regulatory expertise. Candidates should have a degree in a scientific discipline and substantial regulatory experience across the product lifecycle. Strong negotiation and communication skills are essential for this role, which offers a dynamic work environment focused on pharmaceutical development.

Qualifications

• Substantial regulatory experience across the full product lifecycle.
• Solid understanding of pharmaceutical manufacturing processes.
• Able to manage multiple tasks/projects and meet deadlines.

Responsibilities

• Ensure timely regulatory submissions for the NPD team.
• Provide regulatory input and support across the submission phase.
• Manage complex regulatory submissions with minimal oversight.

Skills

Regulatory experience

CMC expertise

Negotiation skills

Communication skills

Project management

Education

Degree in biological/chemistry/life sciences

Job description

A leading pharmaceutical consulting company in the UK seeks a Principal Regulatory Officer to ensure timely regulatory submissions and provide CMC regulatory expertise. Candidates should have a degree in a scientific discipline and substantial regulatory experience across the product lifecycle. Strong negotiation and communication skills are essential for this role, which offers a dynamic work environment focused on pharmaceutical development.