Senior Director Regulatory Strategy

Responsibilities

• Lead the planning, design, and implementation of clinical, nonclinical, and CMC regulatory strategy including the preparation, submission, and maintenance of regulatory applications in a phase-appropriate manner.
• Independently manage the development of high-quality regulatory documents, including direct authoring and/or reviewing of documents such as IND/IMPD/CTA submissions, meeting requests and briefing documents, and responses to regulatory requests for information while adhering to timelines, company standards, and industry guidelines.
• Act as regulatory contact with regulatory authorities, including engaging in meetings with regulatory authorities and managing meeting requests and responses to requests for information from authorities.
• Serve as lead regulatory affairs representative on cross-functional project teams and provide guidance to and oversight of internal and external resources to ensure the company remains in compliance with applicable and phase-appropriate regulatory standards, guidelines, and protocols.
• Provide regulatory input for risk assessments pertaining to the quality, safety, and efficacy aspects of programs and applications.
• Keep up to date on changes in regulatory legislation and guidelines and research regulatory precedence from competitor products, prior approvals, and relevant external programs.

Requirements

• Bachelors degree with 10+ years demonstrated experience in pharmaceutical/ biotechnology environment, with 5+ years in Regulatory

Qualifications

• Direct experience with the following is preferred but not required:
• Experience with complex biologics preferred
• Advanced degree preferred
• Working knowledge of domestic and international regulations and guidelines regarding phase-appropriate drug development, along with the application of principles, theories, and practices
• Direct experience interacting with relevant regulatory 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
• Cardiovascular disease
• Gene therapy, especially gene editing mechanism
• Nonclinical development
• Experience working in highly matrixed team
• Veeva Vault
• Organizational integration