Regulatory Strategy Director

Regulatory Strategy Director

Cambridge

£90,000.00 + (Depending on experience)

The Company

An established yet fast paced pharmaceutical and biotechnology business based in the heart of the Cambridge healthcare scene.  The last 2 years has been big for them on a recruitment front, with a consolidation of their best assets and a restructure ready for their large expansion this year. 

2019 – 2020 means big things for this innovative company, and they want you to be a part of it.

The Role

Working as part of the core management team, you would take on the role of a Regulatory Strategy Director.  Specifically focused on activities such as:

• Providing guidance and experience to the development asset portfolio
• Defining regulatory pathways and all strategic options (including the development of new indications)
• Head up the development and review of the strategic regulatory plan specifically for the assigned assets including the assessment of the regulatory success together with mitigation measures
• Maintain communications with regulatory agencies and bodies and manage communications in line with specific deadlines

This by no means is an exhaustive list and there are a lot of more strategic based responsibilities to this role.

This position sits at Director level within the company

(Compulsory) Requirements

• Extensive regulatory experience (5+ years) in Biotech or pharmaceutical industry
• A strong track record of of overseeing substantial numbers of drug development RA submissions and approvals including CTAs and IND applications
• Experience leading regulatory departments from a strategic stand point
• Strong experience delivering regulatory successes in a variety of demographics (EMA, FDA, MHRA, TGA, PMDA etc).