Senior Principal Regulatory Writer

Are you committed to technical excellence?

Are you an experienced Regulatory Writer working at Senior or Principal Writer level? Are you committed to high standards of delivery and technical excellence?

If so, we can offer you new opportunities in our forward-thinking, friendly and dynamic agency.

Location: Alderley Park, East Cheshire, UK
Job type: Permanent, full-time preferred, although part time/flexible arrangement can be discussed
Benefits: Competitive salary, profit-related bonus, pension, health insurance, 25 days’ holiday and much more!

As a Senior Regulatory Writer, you will prepare clinical regulatory documents in a diverse range
of therapy areas for our pharmaceutical clients, utilising and broadening your existing experience. You will be familiar with documents such as clinical study reports and the common technical document (CTD), and will be able to evaluate scientific data objectively, in order to describe results and scientific concepts in a concise and accurate manner. You will also work with client services and contribute to the strategic planning of regulatory submissions.

In addition to the above, as a Principal Regulatory Writer you will be able to lead the planning and delivery of regulatory submissions and other large regulatory projects.

The person
We are interested to hear from individuals with drug development experience, relevant to the field of regulatory writing. You will need a strong scientific background, including a minimum of a BSc (or equivalent) in an appropriate scientific discipline. You must have excellent written and spoken English skills, and a good working understanding of clinical development and ICH guidelines for regulatory documents. Successful candidates will have a proactive approach, well developed project management skills, and confident and effective interpersonal skills. Flexibility for occasional travel within Europe and the United States is desirable.