Director / Senior Director, Regulatory Affairs – Europe
Ireland or EU (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:
* 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
* Represent Europe on global regulatory leadership teams.
We're looking for someone who brings:
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.- for a confidential chat.