The VP/Executive Director of Regulatory Affairs CMC will be working with company stakeholders and be responsible for the global regulatory CMC strategy and worldwide CMC submissions for the AavantiBio development programs. The position will lead the development and execution of global regulatory CMC strategies for innovative medicines that address unmet medical needs and bring significant value to patients through rare disease development programs and accelerated pathways. You will also be the primary liaison with the FDA, EMA, and other worldwide regulatory bodies for all regulatory CMC interactions, supported by clinical and CMC regulatory strategy infrastructure and expertise. The position will maintain focus on corporate goals while responding to the needs of project teams in a highly dynamic, fast-moving environment.
· 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.
- Develop and maintain a deep regulatory understanding of all elements of gene transfer therapy and components therein, e.g., vector and cell manufacturing process and analytics for AavantiBio products
- Monitor and report regulatory compliance of AavantiBio products and evaluate CMC-related change controls, deviations, and investigations and advise on the impact to filing strategy.
- Prepare, review, and submit high-quality regulatory documentation related to the manufacturing, testing, and release of an AAV-based product for INDs, CTAs, NDAs, BLAs, MAAs, and related filings to regulatory agencies within established timeframes. Responsibilities will include original applications and product maintenance, such as information amendments and annual reports.
- Author/review key CMC documents, such as Module 2 and 3 and other CMC-related sections of regulatory filings
- Partnering with heads of CMC and QA; serves as one of the three key pillars of the CMC regulatory strategy. Provide regulatory input on CMC strategy into the integrated development plan to expedite development, maximize the probability of success, and mitigate risks.
- Communicate and ensure regulatory requirements and strategy are understood by project teams. Evaluate risks to filing strategy and timeline and report to management and stakeholders.
- Provide Regulatory input into all QA policies and systems, such as QMS systems and change controls.
- Track regulatory CMC commitments and deliverables while coordinating with internal and external staff to ensure timely submissions. Interact efficiently and independently with consultants.
- Serve as FDA and EMA liaison and provide leadership and support for all CMC-focused regulatory agency meetings and teleconferences.
- Benchmark with external stakeholders and be up to date with regulatory trends and industry-current status. Be AavantiBio 's face externally with industry regulatory CMC peers.
- Maintain up-to-date knowledge of international and domestic regulatory requirements.
- Initiate and contribute to the development of policies and procedures in alignment with GxPs, corporate guidance, policies, and corporate objectives.
- Support other regulatory affairs function in the company.
- Other Job-related duties determined during the annual objectives setting process and by the key performance indicators.
Skills, Qualifications, and Requirements
- 15+ years' biopharmaceutical experience, including at least 5-7 years of direct experience in Regulatory CMC
- Experience with Reg CMC in cell or gene therapy programs with the FDA/CBER/OTAT and EMA
- Track record of successful IND, CTA, NDA, and/or BLA submissions
- US and EU CMC interactions/experience preferred
- Knowledge of GxP regulations and ICH & FDA guidelines
- Experience with rare disease development programs and expedited pathways preferred
- RAC or education in a regulatory field preferred
- Ph.D. preferred
- Cell biology expertise preferred
- Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results
- Able to blend analytical and critical-thinking skills to enable data-driven, strategically oriented review of regulatory documents
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment
- Demonstrated communication, problem-solving, and negotiation/decision-making skills
- Natural collaborator who enjoys working on a cross-functional team
- Dynamic, interactive, fast-paced, self-starter and entrepreneurial environment
- Limited domestic or international travel may be required
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
Biotechnology | 11-50 employees
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!