Regulatory Affairs Officer - ROW
Hertfordshire, UK – Hybrid/Remote
Regulatory Officer opportunity working for a rare disease biotech based in Hertfordshire. The business works across immunology, critical care, and Coagulation Disorders and are specialist in plasma-derived biological products. They are looking for a Regulatory Officer to support their regulatory team with ROW submissions and maintenance.
As a Regulatory Officer, you will manage all regulatory activities internally and with the distributor for new drug applications and maintain drug licenses for designated products in a designated territory.
Responsibilities
§ Obtain new and maintain existing Marketing Authorisations in the ROW markets.
§ Propose and participate in Regulatory strategy decision-making for new Marketing Authorisations.
§ Post- Approval, lifecycle maintenance, variations (type 1a, 1b, and type 2), renewals, and license changes.
§ Be the main Point of contact with any health authorities seeking advice, guidance or clarification of legal issues or submission processes.
Requirements
§ Bachelor’s degree or higher in Life Sciences or technical field and around 2 years of experience in pharmaceuticals or a related industry. Advanced degree preferred.
§ Strong communication skills and willingness to interact with senior staff.
§ Experience working on ROW markets is a must.
§ Previous experience working with health authorities.
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. The role will allow the right candidate to work directly with the head of regulatory affairs and will be responsible for assigned products.
If you are interested in this role or would like more details please email your CV to lucy.kirkaldy@cpl.com
You MUST have the full right to work in the UK for this position due to the employer not offering sponsorship.