Andy Leake at CK Clinical is recruiting for a Senior Manager, Regulatory Affairs to join a specialised biotech in the pharmaceutical industry at their site based in Cambridge on a 12-18-month contract basis.
Our client is a specialised biotech that focuses on developing therapies for rare diseases. This role is to help develop the regulatory department in order for their first product to enter First in Human Studies.
Your main duties will be:
- Accountable for delivery of regulatory affairs for the company portfolio.
- To provide key input into non-clinical and clinical aspects of regulatory preparation, delivering a regulatory strategy for novel therapeutics in areas of high unmet need, including rare diseases.
- Effective management of outsourced components of regulatory operations.
Further responsibilities will include:
- Planning and delivery of a global regulatory strategy for lead clinical assets.
- Providing guidance to and leading multi-disciplinary teams in the authoring of regulatory communications such as regulatory briefing packages, applications for Scientific Advice Meetings, Orphan Drug Designation, Paediatric Investigational Plans, etc.
- Working directly with the EMA, and other regulatory agencies (either directly or through vendors).
The ideal candidate for this role will have:
- Bachelor's or advanced degree in life sciences or a science related field preferred.
- Extensive proven regulatory experience in Biotech's or Pharma.
- Must have previous experience in leading Major Health Authority interactions
- Extensive experience of regulatory drug development including product approval/launch.
- Proven leadership and program management experience.
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Experience in First in Man is vital.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46537 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Andy Leake
- Phone: 01438 743047
- Reference: 46537
- Posted: 13th September 2019
- Expires: 11th October 2019