Senior Regulatory Affairs Manager, UK, Remote
This is a new opening for a Senior Regulatory Affairs Manager within our UK team.
The Role
Requirements
- 5 years (minimum) of generalist regulatory experience, in small and/or large molecule products, consumer healthcare, and/or animal health products.
- Experience in European procedures, emerging markets and international regions.
- Previous experience working on CMC and/or other reg docs e.g. annual reports, MATs for Small Molecules & Biosimilars.
- A natural aptitude for project management, working to deadlines and dealing with a large volume of different country-specific requirements.
- Experience in paper and electronic regulatory submissions, including delivery to regulatory agencies.
- Ability to liaise with internal colleagues and client stakeholders to ensure that submission requirements and timelines are met.
- Small and large molecule experience, ideally across multiple therapy areas and dosage forms.
- The ability to liaise with internal colleagues and client stakeholders to ensure submission requirements and timelines are mutually understood and in line with standards and deadlines for dossier delivery to regional markets.
- Excellent communication skills are essential, as are diplomacy and negotiation skills.
How to Apply
For further details, please send your CV to: talent@gandlhealth.com
G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.