This client is a next-generation gene editing company focused on the development of best-in-disease therapies for patients suffering from serious genetic disorders and beyond. They are seeking a Regulatory Affairs Senior Director (or Director) who can develop and execute upon regulatory strategies to advance their pipeline toward commercialization. This individual will establish the Regulatory function for the company and work directly with health authorities. This position can be remote with regular travel after the pandemic is over. Now is an exciting time to join this growing organization and help to get innovative gene therapies approved!
- Develop short and long-range regulatory strategies for early stage gene therapy programs, to ensure efficient and expedient drug development.
- Oversee all regulatory filings and interactions, including authorship of critical documents as needed.
- Manage all operational aspects of preparing compliant submissions to Regulatory Agencies.
- Serve as primary interface with FDA and various other competent authorities.
- Manage and build the regulatory and electronic documentation infrastructure.
- Manage regulatory submission timelines in accordance with project plans.
- Maintain submission tracking information and informs project teams and management on real-time status of business-critical submissions and risk and timeline management.
- Oversee the evaluation and analysis of the impact of trends relative to government regulatory activities, relying heavily on strategic thinking, prioritization and problem-solving skills.
- Review product development and in/out-licensing and partnership opportunities.
- Serve as a resourceful and collaborative team member to help inform strategic decisions.
- Bachelor degree in a scientific field required. Advanced degree preferred.
- Seven or more years of experience in Regulatory Affairs for pharmaceutical drugs and biologics.
- Must have experience with biologic programs (antibodies, proteins, etc.) Gene therapy experience desired but not required.
- Successful track record of filing of INDs, CTAs/BLAs, briefing packages, orphan drug applications, and various other important regulatory documents.
- Experiences working in rare disorders and with pediatric patients is key.
- Direct experience working with CBER highly desired.
- Critical thinking about study designs, labeling requirements, manufacturing, and scientific knowledge is needed.
- Strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment and ICH; EMA and other global agencies preferred.
- Experienced in eCTD publishing.
- Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with management.
- Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority‐setting to meet aggressive timelines.
- Self‐motivated, self‐disciplined, and able to function independently as well as part of a team.
- Strategic agility, strong critical and logical thinking with the ability to analyze and propose solutions to problems.
- Demonstrated success leading and scaling teams and proven ability to positively impact company culture and demonstrate flexibility in a fast-paced environment.
- Must be comfortable working for a small organization, and able to handle ambiguity.