Senior Director of Regulatory Affairs

3 days ago

Dublin Pike, Ireland Panda International Full time

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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