The Lonza is looking for an interested candidate for the position of Head of Regulatory Affairs in UK. This is a permanent position and will be based at their Slough facility. Candidate must have expertise in the interpretation and communication of CMC regulatory requirements.
- Post-graduate qualification in biological sciences, chemistry, biochemistry or equivalent education and industry experience
- Bachelor’s degree in biological sciences, chemistry, biochemistry or equivalent education and significant experience in industry
- Significant experience of working in bio-pharmaceutical industry which should include relevant regulatory affairs experience (eg antibodies and/or advanced therapies/translational medicine).
- Demonstrated leadership and ability to manage priorities and work under tight timelines
- Expertise in the interpretation and communication of CMC regulatory requirements for site product and process issues
- Understanding of biologics work processes
- Ability to interpret compliance requirements for the creation or review of protocols and site documentation.
- Working knowledge of US and EU regulatory requirements for biological and early stage drug development.
|Location||Slough, Berkshire (GB)|
|Discipline||Life Sciences, Biotechnology|
- Preparation and review of scientific and technical information
- Drafting of IMPD/INDs and MAA/BLAs
- RoW submission support – Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions
- Support for scientific advice meetings and development of regulatory strategy with customers
- Management of the UK regulatory team covering functions.
- Internal regulatory support for the operation and control of the Slough/Cambridge site.
If you are interested in this opportunity please apply online by clicking on official notice above. Please ensure that you attach your CV to your profile.
Lonza promotes a fast-paced, employee orientated environment and we take pride in both the quality of our products and the success of our employees. They offer a competitive remuneration package and encourage the development of individuals to help them achieve their full potential.