Overview
Reference Number: JO-2307-520009
Regulatory Affairs Executive
Rate: Negotiable
Job Type: Permanent
Location: Hertford
Regulatory Affairs Executive
Hertfordshire, UK – Hybrid
Regulatory Affairs Executive opportunity working for a family-run pharmaceutical company that specialise in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detailed oriented professional to join the small team and support with a number of RA activities.
As a Regulatory Executive, you will be responsible for managing regulatory submissions and variations applications for a range of different generic products.
Responsibilities
- Take responsibility for post-approval activities including, variations (type 1a, 1b, and type 2), renewals, license changes, and CMC change controls.
- Preparation, of new MAA in the UK and Europe and support with any new registration applications.
- Preparation, submission, and management of approvals of National, MRP, DCP, and CP applications in the UK and European region.
- Registration of medicinal products into Non-EU countries
Requirements
- Bachelor’s degree or higher in Life Sciences or technical field.
- 18 months to 2 years of relevant regulatory experience.
- A strong communicator who is able to navigate through difficult conversations with senior stakeholders.
- Previous EU market experience with strong experience submitting through MRP, DCP and national procedures.
This position allows for great career progression opportunities as well as the chance to work for a growing organisation. The role includes some excellent benefits and will be an excellent opportunity for a junior RA professional.
To apply for this role you must have the full right to work in the UK as this employer does not provide sponsorship.
