CMC Regulatory Lead
Biotechnology Clinical Executive Pharmaceuticals
CMC Regulatory Lead
An exciting opportunity has arisen for an experienced CMC regulatory professional to join a growing start-up at their site in Oxfordshire. Offered on a permanent basis, the role of CMC Regulatory Lead is a critical role in successfully delivering innovative drug development/medical device projects. Sitting on the Project Team, you will work across a wide variety of projects delivering against agreed project strategies.
This role is a great career opportunity for a CMC Regulatory Lead who is highly motivated to succeed and enjoys the fast-moving pace that a small biotech company brings, assisting with the development of innovative products.
Some main responsibilities of the role include:
- Developing and execute the CMC strategy and plans for multiple projects
- Manage CROs/CMOs in the development of manufacturing processes and analytical methodology
- Facilitate problem-solving, contingency planning, and decision-making related to all CMC aspects
- Prepare and review regulatory documentation for clinical trials (including IMPDs)
Candidates will be educated to degree level (or equivalent) in relevant scientific technical discipline. The ideal candidate will have a number of years’ experience in the biotechnology or pharma industry with a primary focus on CMC program management, and will be familiar with drug development phases and regulatory requirements. Some other key experience the company are looking for includes:
- Experience managing CMO relationships
- Excellent written and verbal communication skills.
- Ability to build strong relationships and work collaboratively both with internal team members and external CRO partners
Overall this is a great opportunity to join a cutting-edge biotechnology company at an early stage of their life. If this sounds like the opportunity for you, apply with your CV now, and feel free to contact Tom Kirkpatrick at CY Partners for more information.