Senior Director, Regulatory Affairs - Gene Therapy

Senior Director, Regulatory Affairs (Clinical/Non-Clinical Strategy) - Gene Therapy

San Francisco Bay Area - United States

Summary:

Seeking an experienced and highly driven Senior Director Regulatory Affairs (Clinical/Non-Clinical Strategy) to partner with the departments Head to actively contribute and lead the development and implementation of global regulatory strategies for novel drugs. This Senior Director 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. Prior hands-on experience managing and leading studies and submissions and have had direct interactions with global health authorities is required. 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 & Cell Therapy products.

Responsibilities:

• 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 overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally.
• 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.

Professional Qualifications:

• Bachelor of Science degree in Life Sciences or Biology or equivalent required; M.S. or Advanced degrees (PhD/PharmD) preferred
• A minimum of 15 years of relevant regulatory industry experience in a biotech/pharmaceutical setting with 8 years of global regulatory leadership experience managing regulatory teams and led project development teams to successful marketing authorizations.
• Extensive Scientific background with strong understanding of advanced therapy product development; biologics product development is required.
• Strong understanding of advanced therapy products development within Cell and Gene Therapy.
• Advanced Scientific and Technical expertise with clinical and non-clinical development strategy is essential.
• Extensive and comprehensive knowledge of the drug development process.
• Strong understanding and interpretation of GxP protocols and ICH, FDA, & EMA guidelines and regulations to ensure compliance of requirements from healthy authorities.
• Previous experience with BLA/NDA 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 interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com or (646) 430-1191 for more information.