Overview
Reference Number: JO-2309-523412
Senior Regulatory Specialist
Rate: Negotiable
Job Type: Permanent
Location: Borehamwood
Senior Regulatory Specialist – Systems & Publishing
Hertfordshire, UK – Hybrid/Remote
An exciting opportunity to join a rare disease biotech business that works across a range of therapeutic areas. The business has a range of plasma-derived biological products that are registered in global markets. The business is looking for a Senior Regulatory Specialist – systems and publishing to join their regulatory operations team and support with all publishing and systems activities. This position will work closely with the current Senior Regulatory Operations Manager and will be supported by a team in Europe.
The function within Regulatory Affairs is responsible for the planning, creation, and dispatch of high-quality CTD and eCTD dossiers, training authors on and assisting them with source document formatting.
Key Responsibilities
· Oversee the maintenance, optimization, and integration of regulatory information management systems, document management.
· Ensuring compliance of paper, NeeS and electronic dossiers with health authority requirements worldwide with the aim to be fully electronic wherever and whenever possible.
· Develop and maintain Standard Operating Procedures (SOPs), work instructions (WI), and templates related to regulatory systems and operations and RA department as required.
· Identifying system requirements as well as defining and delivering well-suited solutions that meet the needs of authors regarding the preparation and management of source documents, the planning and tracking of submissions, the viewing and archiving of dossiers
Requirements
· Bachelor’s degree or higher in Life Sciences.
· Previous experience working with Veeva Vault Systems.
· Previous publishing experience would be desirable and experience across global markets.
· Good knowledge of regulatory procedures IND, CTA, PSUR, NDA, EU Centralised.
The role is an excellent opportunity to work within an innovative environment and be supporting in implementing Veeva Systems. This opportunity allows for great career progression opportunities as well as the opportunity to work remotely with the occasional meeting in the office based in Hertfordshire.
If you are interested in this role or would like more details please email your CV to lucy.kirkaldy@cpl.com
