Director of Regulatory Affairs

Duties/Responsibilities

• Responsible for complex and potentially multiple projects within the Rare Disease space.
• Responsible for development of regulatory strategies related to development and licensure of biologic development products.
• Represents Regulatory Affairs at project team meetings.
• Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions to deliver on the proposed strategy with the project teams.
• Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that may impact regulatory success.
• Communications demonstrate sound judgement and are provided in a professional and timely manner.
• Responsible for proactively anticipating regulatory risks and for developing mitigation strategies in alignment with team and management; understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed.
• Direct point of contact with health authorities, leads and manages Regulatory Agency meetings, in cooperation with outsourced vendors. Oversees vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates in or leads departmental and cross-functional taskforces and initiatives.
• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Qualifications & Experience

• Bachelor’s degree in a scientific subject area coupled with sufficient industry experience.
• Advanced degrees (e.g. MSc, PhD, PharmD, MD) preferred.
• 8+ years of pharmaceutical industry experience.
• This is inclusive of 6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience.
• Experience in rare diseases, especially rare hematological disorders, preferred.