Associate Director - Regulatory Strategy

Role Summary

Associate Director, Regulatory Strategy role to support the development and implementation of global regulatory strategies for preclinical and early clinical development products, collaborate across teams to provide regulatory guidance, drive health authority interactions, and manage regulatory submissions. Serve as a liaison between internal teams and external partners to communicate regulatory plans and updates, ensuring alignment with company goals.

Responsibilities

• Support and/or lead, as assigned, the development and implementation of phase-appropriate nonclinical and clinical regulatory strategies for novel genome-editing development programs, including engagement with health authorities, management of program gaps and/or risks, and the preparation and submission of regulatory applications.
• Support the development of high-quality regulatory documents, including authoring and/or reviewing documents for IND/CTA submissions, heath authority meetings (requests and briefing documents), expedited program applications, and responses to health authority requests for information, while adhering to timelines, company standards, and industry guidelines.
• Act as regulatory contact with health authorities, including management of email and verbal communications, being accountable for submissions, and taking part in meetings.
• Represent the regulatory affairs team on cross-functional project teams and provide guidance to and oversight of internal and external resources to ensure company remains in compliance with applicable and phase-appropriate regulatory standards, guidelines, and protocols.
• Contribute to the development of risk assessments pertaining to the quality, safety, and efficacy aspects of programs and applications.
• Support regulatory submission processes, timelines, tracking tools, archives, and infrastructure in collaboration with Regulatory Operations, translating functional plans into operational processes and ensuring effective execution.
• Keep up to date on changes in regulatory legislation and guidelines and research regulatory precedence from competitor products, prior approvals, and relevant external programs.

Qualifications

• Advanced scientific degree (i.e., PhD, PharmD) and 4+ years industry-related experience in regulatory strategy and/or drug development experience; OR
• Bachelor‚Äôs degree with 6+ years of industry-related experience in regulatory strategy and/or drug development experience

Additional Preferences

• Experience with gene therapies and/or advanced therapies
• Experience in the cardiometabolic therapeutic area
• Working knowledge of US and international regulations and guidelines regarding drug development, along with application of principles, theories, and practices
• Direct experience leading regulatory submissions and interacting with health authorities
• Excellent written and verbal communication skills
• Demonstrated project management and organizational skills
• Self-motivated and independent work style with the ability to initiate and follow through on assignments