Global Regulatory Affairs Associate Director
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Location
Oxfordshire, England
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Sector:
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Job type:
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Salary:
Negotiable
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Contact:
Matt Thomas
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Contact email:
matt.thomas@pharma-partners.co.uk
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Job ref:
20355_1583856285
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Published:
about 2 years ago
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Expiry date:
2020-04-09
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Consultant:
#
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
