Job title: Regulatory Affairs Associate Director, Neurology Phase II - EU Lead

A biopharmaceutical company based in Oxfordshire are seeking an Associate Director to work on an exciting Neurology product - currently in Phase II. This role will act as the EU Lead and will take responsibility for EMA and CHMP meetings.

Responsibilities:

• Act as EU/ROW regulatory affairs representative on project teams by providing direction and solutions
• Develop and implement EU/ROW regulatory strategies to facilitate the progress of programmes in all phases of development
• Ensure the timely submission of briefing books for regulatory meetings, CTAs MAAs and Variations
• Act as the lead for upcoming EMA and CHMP meetings

Requirements:

• Broad knowledge of EU/ROW Regulatory affairs with direct experience within submissions and approvals
• Proven track record of effective collaboration with regulatory agencies such as the EMA and CHMP
• Minimum of 8 years regulatory affairs experience across the EU/ROW markets

Salary and benefits:

A competitive salary, car allowance, bonus and long-term incentives are on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk