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Head of Regulatory Affairs – Lonza

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.

Position 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.
Employer Lonza
Posted 22-10-2015
Location Slough, Berkshire (GB)
Discipline Life Sciences, Biotechnology
Salary Negotiable
Official Notice

Responsibilities:

  • 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.

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