Vice President, Regulatory Affairs
Taysha Gene Therapies is a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations. The company was founded in partnership with The University of Texas Southwestern Medical Center, or UT Southwestern, to develop and commercialize transformative gene therapy treatments. Together with UT Southwestern, we are advancing a deep and sustainable product portfolio of 18 gene therapy product candidates, with exclusive options to acquire four additional development programs at no cost. By combining our management team’s proven experience in gene therapy drug development and commercialization with UT Southwestern’s world-class gene therapy research capabilities, we believe we have created a powerful engine to develop transformative therapies to dramatically improve patients’ lives. In addition to our product pipeline candidates, we are building a platform of next-generation technologies to optimize key components of our AAV-based gene therapies, including redosing, transgene regulation and capsid development.
Overview of Position
Taysha is currently seeking a seasoned pharmaceutical industry leader to join our Leadership team and manage our Regulatory team as Vice President of Regulatory Affairs. This person will report to the Chief Regulatory Officer and Head of Quality and will be responsible for the development and implementation of our global regulatory strategy. This involves providing regulatory oversight for regulatory activities across the product lifecycle, from development through post-approval, while overseeing department activities and cross-functional teams. This person will also oversee our interactions with the FDA and other global regulatory agencies.
To be successful in this role, you must be able to provide sound regulatory guidance, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. In addition, the successful candidate will create an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.
Essential Duties & Responsibilities
- Working closely with the executive leadership team to lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of Taysha’s products and product-candidates.
- Manages the external regulatory vendor and platform service team members and providers.
- Develop and implement operational plans to achieve the board-approved regulatory objectives.
- Serve as primary regulatory agency contact (at the FDA and at other agencies) to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for Taysha.
- Serve as key point of contact in relation to managing and directing regulatory inspections.
- Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future Taysha products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
- Facilitate strategies for the approval of products in rest-of-world regions either by Taysha or by its partners/affiliates, and act as the senior regulatory contact for ongoing alliance management activities.
- Develop and design robust regulatory structures, processes and procedures and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy.
- Partner with and support clinical development, CMC, medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle.
- Support the Pharmacovigilance and Safety functions as an active member of the Safety Governance and Review team.
- Provide the business development team with guidance and critical evaluation of potential product opportunities, in support of strategic partnering and licensing activities.
- Provide regulatory review and approval of product labeling, promotional claims, and advertising to ensure compliance with corporate policy, and US and international laws and regulations.
- Direct long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.
- Manage internal regulatory procedures to ensure compliance.
- Bachelor’s degree in a science-oriented field of study (e.g. Biology, Chemistry, etc.).
- Minimum of 12 years of professional experience working in the Pharmaceutical, Biotech, and/or Life Sciences industries.
- 10+ years of experience directly in Regulatory Affairs
- 2+ years of experience building and leading a Regulatory Affairs team.
- Extensive experience working and liaison with FDA and other Health Agencies to ensure timely regulatory approvals.
- Completion of Graduate-level coursework in Pharmaceutical, Medical, and/or Life Science-oriented disciplines is a plus.
- Diverse experience working with a variety of pharmaceutical products; experience working with biologics and chemical drugs is a plus.
- Proven success working on regulatory filings for clinical trial applications (e.g. IND, CTA) and new drug applications (e.g. NDA, BLA), etc.
- Deep understanding of relevant US FDA regulations as well as international regulatory agencies (e.g. EU/EMA).
- Experience working with the development of rare/orphan disease products, preferably with gene therapy experience.
- Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.
- Demonstrated excellence in project management with a proven track record of effectively managing multiple projects / priorities simultaneously.
- Experience managing cross-functional teams or work groups as well as direct reports
- Outstanding interpersonal / relationship-building skills, as well as influencing and negotiating skills
- Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
- Excellent communication skills (written and verbal) in English.
The level of this position will be based on the final candidate’s qualifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Taysha is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Taysha are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.
Learn more here
Job posted: 2020-10-06