SVP Regulatory Affairs, Gene Therapy
Remote - Unite States
Seeking an experienced and highly driven SVP Regulatory Affairs to join a small yet very high functioning team and actively contribute and lead the development and implementation of global regulatory strategies for novel gene therapy AAV drugs. This Executive will work collaboratively cross-functionally with the team and will have the opportunity to lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Seeking a strong and confident, proven global leader to lead development, as well as provide oversight, share global regulatory expertise and strategic direction, while supporting and mentoring all aspects of the clinical development programs in advanced Gene Therapy products.
- Provides regulatory leadership and direction on the global regulatory strategies on specific clinical development projects teams for groundbreaking gene therapy products; developing strategies for long and short-term planning to ensure regulatory compliance.
- Provide regulatory oversight for regulatory activities across the product lifecycle, from development through post-approval, while overseeing department activities and cross-functional teams.
- Provide overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally.
- Oversee all activities and interactions with FDA, EMA, and ROW global regulatory agencies.
- Proven ability to lead multidisciplinary teams towards common goals through development/approval challenges by managing and building consensus among multiple stakeholders.
- Lead and oversee regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance.
- Successful track record of direct interactions with global health authorities and leading teams to successful results per company goals and successful in leading Health Authorities and/or Advisory Boards meetings is required.
- Strong ability to work and manage multiple projects at any given time, strong people management skills.
- Ensure global regulatory requirements and strategy are understood by project teams; strong ability to work and manage effectively with a variety of personnel across a matrix environment.
- Bachelor of Science degree in Life Sciences or Biology or equivalent required; M.S. or Advanced degrees preferred.
- A minimum of 15 years of relevant regulatory industry experience in a biotech/pharmaceutical setting with 10 years of global regulatory leadership experience managing regulatory teams and led project development teams to successful marketing authorizations.
- AAV and LVV gene therapy program exposure and hands-on experience.
- Biologics/Large Molecules product development is required.
- FDA Regulatory Pathways for vector gene therapy.
- Experience interfacing and responding to relevant global regulatory authorities, with respect to gene therapy products.
- Extensive scientific background with strong understanding of advanced therapy product development.
- Thorough understanding of the drug development and able to interpret, analyze and communicate clinical and scientific data, pharmacovigilance and has the ability to develop regulatory strategy and Pharmacovigilance (PV) efforts with the company's lead asset.
- Advanced Scientific and Technical expertise with clinical and non-clinical development strategy is essential.
- Strong understanding of advanced therapy products development within Gene Therapy including multidisciplinary experience.
- Extensive and comprehensive knowledge of the drug development process.
- Prior hands-on experience managing and leading studies and submissions and have had direct interactions with global health authorities is required.
- Strong understanding and interpretation of GxP protocols and ICH, FDA, & EMA guidelines, and regulations to ensure compliance of requirements from healthy authorities.
- Previous experience and strong knowledge of IND and NDA regulatory filings.
- Ability to think strategically and critically and evaluate risks to regulatory activities; ability to work effectively within a complex, business critical and high-profile development program.
- Key skills: Strategic thinking & influencing, effective leader and team player, initiative, management, communication, negotiation, and presentation skills; organizational and effective management skills; verbal and written communication skills are essential; strong technical skills with MS Office Suites; highly polished and strongly experienced leader with a proactive demeanor and team player attitude.
If you meet the above qualifications and interested in learning more, please contact Bria Gaber at firstname.lastname@example.org for more information.