Senior Regulatory Affairs Manager - Clinical Stage Biotech

We are currently partnering with an exciting clinical-stage Biotechnology company looking to hire a Senior Regulatory Manager to work alongside the Regulatory Affairs Senior Director. This is a truly ground breaking company with a patient centric approach. The successful candidate will participate in the development and implementation of regulatory strategy for specific programmes. 

Office Location:

Hertfordshire with the flexibility for 2 – 3 days a week working from home if desired. 

Responsibilities:

·       To design the execution of certain regulatory activities/submissions necessary to support global product development and registration 

·       Support regulatory sub-team and product development teams in all aspects of regulatory affairs, both strategic and operational 

·       Ensuring preparation of high-quality regulatory documents including, but not limited to, IMPD/CTA/IND, scientific advice briefing documents, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings to support regulatory compliance. 

·       Act as contact point for internal and external clients, including CROs and regulatory authorities 

·       Help with training of staff in regulatory matters. 

·       Extensive project management activities across Regulatory Affairs 

Education / Requirements: 

·       Relevant degree in a life science / science discipline. 

·       Previous Regulatory Affairs experience working on early phase products 

·       Rare disease / Orphan Drug applications experience is preferred but not essential 

For further information on this position please get in contract with Natalie Jones on 0207 183 5059 or email Natalie directly at natalie@linkfieldgroup.com