Who We Are:
We are an integrated genetic medicines company developing targeted, disease-modifying medicines for patients with life-limiting respiratory diseases. Our treatments address the underlying genetic cause in underserved populations and have the potential to tremendously impact the quality and length of patients’ lives.
At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission: harnessing our multi-platform approach to develop disease-modifying medicines. Our team is uniquely positioned to tackle this challenge, given our extensive experience in RNA delivery technologies, protein structure, tRNA biology, mRNA manufacturing, gene editing, and drug development.
Summary of Position:
The Senior Director, Global Regulatory Affairs will report to the Senior Vice President, Clinical Development. You are a leader that will develop and implement US and global regulatory strategy for ReCode’s programs and make strategic contributions to our product development plan. You will be responsible for building a team of direct reports and collaborate with our cross-functional teams to deliver on ReCode’s mission of powering the next wave of genetic medicines. You will have substantial experience in either rare diseases or genetic medicines such as mRNA, gene therapy or gene editing.
- Develop and implement the US and global regulatory strategies aligned with business objectives for ReCode’s portfolio of genetic medicine programs in development
- Build, manage and lead a regulatory affairs team to support the growing pipeline in development
- Provide guidance, direction, and leadership on regulatory strategy to senior management
- Make strategic contributions to product development plans from discovery through to approval
- Be the primary liaison with regulatory authorities for day-to-day interactions
- Maintain up-to-date working knowledge of US laws, regulations, and guidelines as well as familiarity with the global regulatory environment
- Oversee the preparation of meeting requests, briefing documents, and teams for meetings, and interactions with regulatory authorities
- Build and deliver the global regulatory strategy from IND/CTA to BLA, and collaborate with program leadership, clinical, nonclinical, CMC, quality assurance, project management, and other relevant functional areas to drive product development towards successful registration and approval
- In alignment with corporate objectives develop and implement risk registers/mitigation strategy and plan and ensure regulatory compliance for assigned development programs
- Lead cross functional teams to prepare and review regulatory documents to ensure high quality and timely submission to health authorities, including but not limited to IND and amendment, BLA, safety reporting, periodic reporting, and response to health authority questions
- Manage labeling development, and advertising/promotional review activities
- Lead the regulatory interactions and meetings with health authorities such as FDA, EMA, MHRA etc
- Monitor the changes in regulatory environment, regulation, regulatory guidance, and regulatory guidelines. Advise companies on the potential impact of these changes on company drug development programs and adjust regulatory and risk mitigation strategies accordingly
- Support business needs to take on additional project responsibilities as assigned by management.
- Guide regulatory consultants and contractors to complete and/or manage all assigned responsibilities in a timely manner e.g., regulatory project management and operations
- Advanced Degree (PharmD, PhD, MPH, or equivalent) in a scientific field preferred
- 15+ years of Regulatory Affairs experience in the biotech/pharma industries
- Regulatory experience working on genetic medicines (e.g., gene therapy, mRNA, gen editing or similar) and with CBER-OTAT
- Rare disease/orphan drug experience, required
- Regulatory experience across all phases of development from Pre-IND through BLA submission and approval, required. Prior experience of leading an IND and a BLA is required
- Experience preparing pre-IND, IND and BLA documentation is required
- Track record of success in negotiating with Health Authorities and representing the sponsor to internal and external stakeholders
- Prior experience leading and managing a regulatory team
- Track record of successful IND/CTA submissions and approvals/clearance
- Demonstrated knowledge of drug, biologics and medical device regulation, directives, and regulatory guidance and guidelines. Solid knowledge of GCP, GMP and GLP
- Experience in leading matrix teams to fulfill regulatory requirements and responsibilities with strong communication
- Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously
- Excellent oral and written communication skills
ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.
ReCode Therapeutics is an Equal Opportunity Employer.