Senior Director, Regulatory Affairs
AavantiBio is seeking a Senior Director of Regulatory Affairs, responsible for developing and delivering innovative, breakthrough global regulatory strategies for gene therapy product development and approval, in alignment with the global business strategy for gene therapy products.
· Full-time salary position with the opportunity for annual bonuses and participation in the Equity Incentive Plan. Benefits include high-quality health insurance plans including both gold and platinum Blue Cross Blue Shield plans, for which AavantiBio pays a competitive 85% of the health insurance premiums for our employees and their families. In addition to health insurance, we have put in place flexible spending accounts and other benefits for our employees, including dental, vision, short- and long-term disability, group life insurance, AFLAC, and more. To assist our employees with their retirement planning, AavantiBio offers a safe-harbor 401(k) plan with a generous 6% company match.
Responsibilities – These may include but not limited to:
· Directs AavantiBio’s regulatory affairs activities, strategies, and operations for the portfolio of cell and gene therapy products.
· Provides regulatory guidance throughout the research and development process.
· Identifies and evaluates regulatory risks and establish strategies to mitigate such risks.
· Prepares clear and effective regulatory submissions on behalf of AavantiBio’s portfolio leveraging internal and external resources.
· Acts as the primary AavantiBio contact with regulatory bodies in the US and Internationally.
· Supports the preparation for meetings with regulatory bodies to include but not limited to Pre-IND meetings, Type C meetings, EOP II meetings, pre-BLA meetings, Advisory Committee meetings, and presentations in front of members of CHMP including rapporteur meetings and Scientific Advice
· Oversees and analyzes appropriate regulatory agency activities in areas of interest to the company. Assesses impact on programs.
· Builds and maintains strong relationships with relevant regulatory agencies.
· Effectively collaborates and manages contractors and corporate partners.
· Prepares and delivers effective presentations for external and internal audiences
- Other Job-related duties determined during the annual objectives setting process and by the key performance indicators.
- B.S. M.Sc, Ph.D., or M.D. degree, preferably in microbiology, chemistry, or biochemistry. PhD. or M.D. is preferred.
· Minimum 8 years of pharmaceutical/biotechnology industry experience in Regulatory Affairs.
· Minimum 5 years’ experience with cell and gene therapy products, experience with oncology therapeutic products and experience with co-diagnostic development highly desirable.
· Experience and success with a small biotech company environment.
· International regulatory experience (US and EU).
· Knowledge and experience in interpretation of regulations, guidelines, and policy statements.
· Experience in the preparation of major regulatory submissions and supportive amendments or supplements for early and late-stage development programs, including both clinical and pre-clinical aspects of the project; direct experience in interfacing with relevant regulatory authorities.
· Solid knowledge of GxPs.
· Excellent communication skills.
· Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
- Excellent problem solving and quality critical thinking.
· Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
· Experience with eCTD, e-publishing systems for preparing regulatory submissions.
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.
EQUAL OPPORTUNITY EMPLOYER
AavantiBio is committed to nondiscrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
About the company
11-50 employees - Biotechnology
AavantiBio is a clinical-stage biopharmaceutical company committed to developing and commercializing novel gene transfer and gene editing therapies for the treatment of rare and ultra-rare genetic diseases. The company is rapidly building a diverse portfolio of gene transfer and gene editing therapies to target debilitating genetic diseases for which the unmet medical need is high and for which there are typically no approved therapies treating the underlying disease.
AavantiBio is headquartered in Cambridge, MA with an additional location in Gainesville, FL. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene transfer therapy.
Developing genetic treatments for rare diseases is inspiring but challenging work and it takes dedication and courage which will make a meaningful impact on those who suffer from rare diseases. At AavantiBio, we will push each other to perform at our very best and build a company that not only our employees are proud of, but also the rare disease community, because everyone knows we are trying to make a difference in patients’ lives.
Come join our team!