Head of Regulatory Affairs

July 11

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AL Solutions

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A global headhunting team supporting the Life Science industry across the UK, EU, USA.

trials • consulting • health economics • market access • clinicalresearch

11 - 50

Description

• Spearhead our global regulatory strategies across our innovative product portfolio • Lead crucial interactions with regulatory authorities, including FDA, EMA, and others • Oversee regulatory filings from INDs to NDAs and MAAs • Build and mentor a high-performing regulatory affairs team • Collaborate with our clinical, medical, and commercial teams to drive success • Keep us ahead of the curve on evolving regulatory landscapes, especially in rare diseases • Provide valuable regulatory insights to support our business growth

Requirements

• A regulatory affairs expert with an advanced degree in Life Sciences or Pharmacy • A seasoned professional with 10+ years in Regulatory Affairs, including 5+ years leading teams • A strategic thinker with a track record of successful regulatory approvals, particularly in orphan drugs • An in-depth understand of global regulatory requirements and processes • A natural leader who can inspire and develop top talent • An excellent communicator with a patient-focused mindset

Benefits

• The opportunity to directly impact patients' lives through your work • Competitive compensation and comprehensive benefits • A collaborative, innovative environment where your ideas matter • Clear paths for professional growth and development • Flexible working arrangements for a healthy work-life balance