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EU Regulatory Affairs Director

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

Job Description

EU Regulatory Affairs Director

This is a rare opportunity to join a young, exciting clinical-stage biotechnology company.

Our client is a clinical-stage neuroscience company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive, life-threatening diseases

The Director, Regulatory Affairs will be responsible for collaborating on global regulatory strategies, and for planning, managing and executing regulatory filings and communications for investigational drug products in the EU and other regions as applicable, in compliance with current regulations and standards.
Job Spec
  • Provide strategic input based on regional expertise to the global regulatory team and to cross-functional project teams for EU-based regulatory activities including EMA and national scientific advice
  • Define strategies for timely and effective regulatory submissions for initial CTAs, responses to regulatory requests, amendments, annual updates and other filings as required
  • Execute regulatory strategies, working as needed with local regulatory affairs consultants and vendors for translation, submission of regulatory documentation and contact with EMA and local Competent Authorities in a professional, compliant and timely manner
  • Serve as Official Correspondent/Contact Person for EU regulatory authorities as required
  • Represent our client to the EU regulatory community; serve as a liaison with EMA and national authorities, maintaining effective collaborative relationships
  • Maintain and expand working knowledge of applicable regulatory requirements and precedents to inform both regulatory strategies and requirements for development programs, providing updates to project teams and/or functional areas as needed
  • Participate in selection and ongoing management of regulatory contractors and CROs to ensure timely and effective regulatory communications and compliance
  • Ensure regulatory filings are maintained in global archiving system on a timely basis
Person Spec
Education and/or Experience:
  • Advanced or Bachelor degree in a scientific discipline; life sciences preferred
  • >7 years of regulatory experience, preferably with at least 3-5 years in a similar EU-based leadership role
  • Ability to manage all aspects of regulatory activities from pre-CTA/IND through late-stage clinical development, including oversight of regulatory contractors and partnership with CMC Regulatory; product registration/commercial experience a plus
  • Demonstrated experience leading preparation, submission and maintenance of key regulatory filings in collaboration with project teams, including CTAs, Scientific Advice/Protocol Assistance and other key procedures
  • Prior regulatory liaison experience, including ability to build effective relationships with EMA and local regulatory agencies; global regulatory experience preferred
  • Track record of effective collaboration on project teams, and across multiple organizational levels and functions
Competencies and Attributes:
  • Ability to build and maintain effective internal and external relationships, including cross-functional teams, regulatory agencies and contract research organizations
  • Excellent strategic, planning and organizational skills, including the ability to support and prioritize multiple projects, as needed
  • Demonstrated competence in understanding and effectively applying current regulatory requirements in an emerging regulatory landscape
  • Must display strong analytical and problem-solving abilities
  • Excellent written and verbal communication skills essential
  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with our client’s culture and values

Cv to gerry@rftgroup.ie 01 2302400