about 2 months ago
Job title: Senior Regulatory Affairs Associate - EU New Submissions
A global pharmaceutical company in Essex are seeking a Senior Regulatory Affairs Associate. This role will focus on new submissions of generic products in the EU.
- Manage new MAAs submitted via Decentralised (DCP) and Mutual Recognition (MRP).
- Provide central RA support to EU countries, CH and International markets
- Coordinate preparation of high-quality dossiers which fulfill regulatory requirements and Health Authority (HA) expectations.
- Keep up to date on regulatory trends, risks and opportunities in the EU Region.
- Prepare and manage the post-approval commitments and maintenance work on post-approval variations for authorised products
- Experience in registration of medicinal products in the EU.
- Regulatory knowledge throughout product life cycle with substantial experience with various products/devices.
- Pharmacy/Chemistry or Life Sciences degree.
- Regulatory strategy development with a focus on bringing innovative solutions to project teams and health authorities.
Salary and benefits:
A highly competitive salary, annual bonus, health insurance and wider benefits package is on offer
To apply for this position or hear further details then please contact Matt Thomas via email@example.com