Associate/Director Regulatory CMC
AavantiBio is looking for an experienced in Regulatory CMC who will work with the company stakeholders and be responsible for the global regulatory CMC strategy and worldwide CMC submissions for the development programs. The position will lead the development and execution of global regulatory CMCM strategies for innovative medicines that address unmet medical needs and bring significant value to patients through rare disease development programs and accelerated pathways. The position will maintain focus on corporate goals while responding to the needs of project teams in a highly dynamic, fast-moving environment.
This individual will report to the Chief Regulatory Officer and can be based in office space to be identified by the Company in the Cambridge/Boston area of Massachusetts, in the office in Gainesville, Florida, or located remotely in the Eastern time zone of the US.
Full-time position. 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 include but are not limited to:
- Works in close collaboration with CMC and QA. 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 strategies are understood by project teams. Evaluate risks to submission strategy and timelines and report to management and stakeholders.
- Prepare, review, and submit high-quality regulatory documentation related to the manufacturing, testing, and release of an AAV-based product, INDs, CTAs, marketing applications, 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 as well as briefing packages and Agency response documents.
- Develop and maintain a deep regulatory understanding of all elements of gene 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 submission strategy.
- 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, EMA, and local EU health authority 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 face externally with industry regulatory CMC peers.
- Maintain up-to-date knowledge on international and domestic regulatory requirements.
- Initiate and contribute to the development of policies and procedures in alignment with , corporate guidance, policies, and corporate objectives.
- Be an active and contributory member of the regulatory function as we build to support future.
Required Education, Experience , and Skills:
- 7+ years biopharmaceutical experience, including at least 5 years of direct experience in Regulatory CMC.
- Experience in gene therapy vectors preferred, especially in AAV.
- Advanced degree in a life science preferred, Ph.D., PharmD, or Master’s degree.
- Track record of successful IND, CTA, NDA, and/or BLA submissions
- US and EU CMC interactions/experience preferred.
- Knowledge of regulations and ICH & FDA guidelines
- Hands-on, roll-up-your-sleeves approach, with a 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.
- Ability to work with MS Word and electronic document management systems, including strong skills in the presentation of documents.
- Ability to work in a cross-functional development team environment.
- Excellent scientific/analytical ability.
- Excellent communication skills (written and verbal).
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 an employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
About the Company
Biotechnology – 50-70 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.
Headquartered in Cambridge, MA with an additional location in Gainesville, FL, AavantiBio is looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene transfer therapy.
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.