Principal Consultant (Associate Director)
UK/EU based
Fully remote working
Attractive salary/package
Responsibilities and Accountabilities
Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans.
Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data.
Lead interactions with local / regional regulatory authorities.
Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally
Implementation of the regional strategy(s) in support of the project globally
Lead regulatory interactions and the review processes in local region
Ensuring appropriate interaction with regional commercial teams in local region
Ensuring compliance with regional requirements at all stages of product life
Experience, Skills and Specialized Knowledge
Required (include required and preferred education and experience)
Bachelor degree or preferably PhD in biological or healthcare science
Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence. Proven experience of leading regional development, submission and approval activities in local region(s). Capable of organising and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority
Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally.
Extensive knowledge of relevant area of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area.
Ideally also a significant external network at least into other pharmaceutical companies and recognised internally and externally as an expert broadly or in specific areas of regulatory affairs
If you are interested then please apply or email directly at ed.taylor@cpl.com
- Agency: Cpl Life Sciences
- Reference: JO-2206-494770
Website: Cpl Life Sciences
- Posted: 14th June 2022
- Expires: 12th July 2022
