This early stage biotech company is developing precision genetic medicines through base editing and cell therapies for the treatment of serious diseases. They are seeking a Regulatory Affairs Director or Senior Director who can lead and execute regulatory strategies for their programs in development. Reporting into the SVP of Regulatory, you will interface directly with health authorities and work with cross functional teams to advance their innovative genomic medicine programs. This company offers cutting-edge science, a values-driven company culture and unlimited Paid Time Off! With their first program going into clinical trials this year and a strong cash position, now is an exciting time to join this growing organization.
Responsibilities:
- Provide regulatory strategic leadership to support development of innovative genomic medicines and cell therapies.
- Plan and manage activities for the preparation of high-quality global regulatory submission elements, including authoring and/or critical review to ensure compliance with regulatory requirements, in accordance with program timelines.
- Lead and support global health authority interactions, including defining strategy, preparation, and meeting facilitation.
- Incorporate the evolving global regulatory requirements and guidances with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough treatments and other expedited regulatory approval pathways from first-in-human to post-marketing application stage.
- Represent Regulatory Affairs on cross functional and project teams to ensure regulatory input into non-clinical, clinical and commercial strategies.
- Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks.
- Guide and assist on the planning, preparation, writing and submission of regulatory documentation.
- Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time.
- Provide regulatory due diligence as required.
- Potential to supervise and mentor direct reports.
- Develop regulatory processes and procedures to support regulatory submissions.
- Support the creation and maintenance of submission templates and dossier standards.
- Develops and maintains collaborative partnerships with key internal and external stakeholders.
- Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global regulations and guidance, and provide regulatory advice to project teams
Required Qualifications:
- Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- Ten or more years of industry experience with 8+ years in Regulatory Affairs for novel products.
- Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP, etc.)
- Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines; with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products.
- Must have Regulatory experience with Rare Disease programs and/or Oncology indications.
- Record of success with interactions with FDA and other Regulatory Agencies.
- Comprehensive knowledge of US and global regulatory procedures and practices. Global experience a plus.
- Strong strategic thinking and problem-solving skills.
- Experience in representing programs to internal and external stakeholders.
- Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors.
- Excellent written/verbal communication skills, attention to detail, organizational skills.
- Demonstrated ability to mentor and manage.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.