about 1 year ago
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.
- 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
- 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 firstname.lastname@example.org