Sr Director, Regulatory Affairs

Location: Remote (EST time zone)

Salary: Market-competitive

Purpose of the Role

The Director/Senior Director of Regulatory Affairs will report to the Vice President of Regulatory Affairs and serve as a global liaison to regulatory authorities for gene therapy products.

Responsibilities

• Develop and implement global regulatory strategies that support efficient development and registration of gene therapy products.
• Work proactively in a cross-functional organization to help execute effective regulatory strategies in alignment with nonclinical, CMC, and clinical development plans and portfolio strategy.
• Lead the preparation, review, and submission of regulatory applications including: INDs/CTAs and amendments, BLAs/MAAs and supplements, Annual Reports, PIPs/PSPs, and specialty designation applications (e.g., Fast Track, RMAT, PRIME, ILAP).
• Prepare for and lead negotiations with FDA, EMA, MHRA, and other health agencies. This includes preparing responses to questions and inquiries from health authorities, overseeing the writing of meeting materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow-up.
• Independently manage projects and execute as the Regulatory Affairs lead, both in an operational and technical role.
• Review critical regulatory communications and evaluate conformance with regulatory requirements, clarity, and completeness.
• Identify potential regulatory risks to the strategic/operational plans and propose options to mitigate risks.
• Work with Regulatory CMC and Regulatory Operations to prepare, produce, and submit health authority documents using internal and external resources.
• Manage contracted third-party providers.

Key Performance Indicators

• Achievement of product development milestones.
• Maintenance of compliance with product reporting requirements.

Qualifications

• Bachelor’s degree in a scientific discipline with 10+ years of pharmaceutical industry experience, predominantly in Regulatory Affairs.
• Master’s degree, PharmD, or PhD preferred.
• RAPs certification preferred, but not required.

Skills

• Excellent organizational, communication, and time management skills.
• Thorough knowledge of the drug research, development, and commercialization processes.
• Cross-functional leadership.
• Strategic planning and execution.
• Stakeholder communication and influencing.
• External partner management.
• Ability to set and achieve challenging goals, demonstrate persistence, and overcome obstacles.
• Strong verbal communication: speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
• Strong written communication: writes clearly and informatively; edits work for spelling, grammar, and formatting; varies writing style to meet needs; able to read and interpret written information.
• Sensitivity and experience with non-domestic organizations/cross-cultural environments.