Senior Director, Regulatory Affairs EU

4 weeks ago

London, Greater London, United Kingdom Lifelancer Full time
Job Title: Senior Director, Regulatory Affairs EU

Lifelancer is seeking a highly experienced Senior Director, Regulatory Affairs EU to lead our regulatory affairs efforts in the European region. As a key member of our team, you will be responsible for developing and implementing regional regulatory strategies for our compounds in all stages of clinical and commercial development.

Key Responsibilities:
  • Develop and implement regional regulatory strategies for PTC compounds in all stages of clinical and commercial development.
  • Serve as a liaison to regional regulatory Health Authorities, including the European Medicines Agency (EMA), the UK MHRA, and other national authorities.
  • Define strategies for, coordinate the execution of, and ensure the proper archival of regulatory submissions, including Clinical Trial Applications (CTAs) and Marketing Authorization Approvals (MAAs).
  • Provide regulatory support for country-specific Early Access Programs (EAPs) and prepare supportive regulatory documents for these programs.
  • Collaborate with project teams and other internal and external key stakeholders to ensure effective local product registrations.
  • Provide guidance to EU team Regulatory Team Members in the executing of their projects, strategically and operationally.
  • Ensure that drug products distributed in the region meet local regulatory requirements while also supporting PTC's commercial/business objectives.
  • Provide regulatory support to the Global Pharmacovigilance (PV) organization as necessary to ensure that PTC's PV obligations within the region are met.
Requirements:
  • Experience in rare or orphan disorders research, with a focus on small patient populations and urgent unmet medical need.
  • Recent in-depth experience with the Centralized Registration Procedure.
  • In-depth knowledge of relevant, regional regulatory guidelines and requirements for application in an emerging regulatory landscape.
  • Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
  • Demonstrated, hands-on experience leading, managing, and preparing regional/country-specific regulatory submissions, including knowledge of National, Mutual Recognition, and Decentralized/Centralized procedures.
  • Demonstrated track record of success building relationships with, and influencing, regional and/or national health authorities, particularly in situations requiring direct interaction/negotiation.
  • Demonstrated success gaining regional regulatory approval and providing regulatory support for post-marketing and life cycle management activities, such as variations, renewals, and labeling.
  • Experienced providing regulatory support for CTAs and Chemistry, Manufacturing, and Control (CMC) related activities.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization, and time management skills, including the ability to support and prioritize multiple projects.

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