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.

Responsibilities:

• 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

Requirements:

• 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 matt.thomas@pharma-partners.co.uk