Your newpany
A globally emerging pharmaceuticalpany focusing on generic medicines across the EU and UK markets. A strong focus on progression, collaboration and development, thispany would serve as the ideal place of employment to boost your regulatory career. This role is based in Maidenhead and is an office-based role. Very accessible via both car and public transport. Hiring across Officer - Manager level dependent on experience. Salary from £30,000 - £65,000 dependent on experience.
Your new role
1. Prepare and submit applications to MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
2. Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions
3. Reclassification of Medicines
4. Re-baseline / Remediation dossiers
5. License Transfers (giving away and bringing in) including the due diligence of dossiers
6. Maintenance of Marketing Authorisations including renewals
7. Deficiency responses to authorities
What you'll need to succeed
8. Experience with Regulatory Affairs within Generic products for UK and/or EU markets. Either is fine, both are better.
9. Ability to travel on-site to Maidenhead
10. Must have UK Right to Work - No Sponsorships at all
What you'll get in return
11. Salary/promotion review twice a year
12. Fast Career Progression