Senior Director of Regulatory Affairs
3 weeks ago
Overview
Director / Senior Director, Regulatory Affairs – Europe
Location: Ireland (onsite presence required, hybrid flexibility)
Therapeutic Area: Rare Diseases
We are supporting a fast-growing biopharmaceutical company developing transformative therapies for rare diseases . With an established global operations and expanding European presence, the company is preparing for a pivotal stage in its growth and is now seeking a Regulatory Affairs leader for Europe .
This is a unique opportunity to step into a senior leadership role where you will:
Responsibilities
Lead regulatory strategy and execution across all EU markets.
Act as the primary interface with EMA and national competent authorities .
Oversee submissions including MAAs, variations, and renewals .
Shape and align regional strategies with global business objectives .
Partner with Clinical, Medical, and Commercial teams to guide programs in rare diseases.
Represent Europe on global regulatory leadership teams.
Qualifications
15+ years of regulatory affairs experience in biopharma.
Proven leadership in EMA procedures (centralised and decentralised).
Hands-on experience with rare disease .
Strong track record in agency interactions and negotiations .
Strategic vision, collaborative mindset, and the ability to influence at the executive level.
This is a chance to make a direct impact on patients living with rare diseases , while leading regulatory affairs for Europe at a critical time of growth.
If you are interested in exploring this opportunity, please reach out directly to a.brenner@panda-int.com for more info.
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