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Regulatory Affairs Director

Location: Unknown
Contact Name: Director of The RFT Group
Contact Email: gerry@rftgroup.ie

Job Description

Director, Regulatory Affairs
Rare exciting opportunity to play a key role building a global leader in healthcare innovation


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.


Person Spec

• 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
commercialization.
  • 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
such organizations.

• 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 gerry@rftgroup.ie