|Director, Regulatory Affairs|
The Director Regulatory – Europe (located in Dublin, Ireland) will be a key contributor and stakeholder in our client’s regulatory and commercial activities across Europe, which may include direct or long-term agreements with one or more strategic partners. This role will have dual reporting lines to the US, Regulatory functional head and to the Chief of Operations in Dublin.
• Regulatory oversight of all regulatory aspects in Europe, including CTAs, MAAs, advertising and promotion, etc.
• Proven track record as regulatory lead supporting multiple successful, high-profile product launches in Europe.
• Deep understanding of EU regulations, directives, and guidelines associated with drug product development and
- Proven track record in playing a key role in EU product launches
• Track record of playing a key/lead role in obtaining regulatory approval via EMA’s centralized procedure.
• Extensive direct experience of interacting with EMA and other relevant regional regulatory agencies across EU.
Experience acting as the primary contact point with EMA on centralized procedures a major advantage.
• Background in regulatory strategy and/or clinical-regulatory drug development desired; additional experience with
regulatory-CMC a major advantage.
• Building and/or maintaining relationships with consultants, key strategic partners, and vendor network to facilitate
post-authorization lifecycle management and other regional projects and initiatives.
• Experience managing and working with third-party vendors and consultants, including leveraging the scalability of
• Cardio/metabolic therapeutic area/product experience a major advantage.
• Strong communications skills (written and verbal) are necessary.
• Proactive nature and appreciation for accountability are necessary.
• Fluent English is necessary. Ability to conduct business in other European languages are an advantage, in
particular: German, French and Spanish
• Demonstrated ability to work solo and networked as part of a broader US/European organisation; keen sensitivity
to the impact of their role on internal business colleagues and external strategic partners.
• Position is based in Dublin; Comfort with a Europe-based role that may require travel across the continent as well
as to both Dublin, and the USA
• Fifteen + years’ experience in the pharmaceutical industry with ten years’ experience in pharmaceutical regulatory
leadership roles, specifically in Europe.
• Primary/Bachelor’s degree essential, advance degree preferred.
Cv to firstname.lastname@example.org