This clinical-stage biotechnology company is developing potentially curative therapies for heart disease. They are seeking a Regulatory CMC Executive Director or Senior Director to lead CMC Regulatory strategies and execution for their portfolio of programs. Reporting into the SVP of Regulatory, you will lead CMC submissions and work directly with health authorities. This company offers a science-driven, patient-focused culture and excellent employee benefits. With multiple programs in clinical trials, now is an exciting time to join this growing company!
- Develop and lead CMC Regulatory strategies for a portfolio of programs in development, including AAV gene therapies and small molecule drugs.
- Proactively guide CMC team to design, develop, and implement submission documents and best practices for CTD quality modules to streamline preparation of CMC submission content.
- Participate on cross-functional CMC teams and provide regulatory CMC guidance for assigned products.
- Function as the Regulatory CMC lead on viral vector project and submission teams by applying advanced knowledge of regulations. Interpret technical regulatory guidelines to ensure that regulatory submissions are in compliance with applicable regulations.
- Strategize on deliverables to ensure Module 3 content associated with viral vector meets regulatory requirements and projected business timelines.
- Identify CMC risk areas and develop alternative courses of actions including anticipation of regulators responses through scenario planning and development of contingency plans.
- Align CMC regulatory strategy to overall regulatory business strategy (e.g. viral vector upcoming process, raw material, shelf-life and analytical changes).
- Responsible for assessment of all CMC related changes associated with viral vector and facilities/ equipment.
- Provide regulatory CMC expertise during due diligence and in support of new projects associated with viral vector.
- Responsible for submitting or ensuring submission of all regulatory documents that are required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories.
- Maintain an in-depth knowledge of ICH requirements, and an understanding of current global trends in CMC Regulatory Affairs.
Background and Qualifications:
- BS in a scientific discipline is required. MS or preferred
- Ten or more years of Regulatory CMC experience for biologic therapeutics.
- At least two or more years of Regulatory CMC experience with AAV Gene Therapy programs is required.
- Proven sound understanding of molecular biology and cell culture.
- Strong knowledge and understanding of US and ex-US regulations and ICH guidelines.
- Experience working directly with FDA/CBER, including meeting preparation and responding to inquiries. Experience working with Ex-US Health Authorities (EMA and MHRA) a plus.
- In-depth understanding of cGMP requirements of manufacturing facilities and equipment in support of clinical and commercial productions.
- Proven experience in supporting regulatory inspections.
- In-depth knowledge and experience in viral vector production, purification, characterization and analytics.
- In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
- A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
- Experience in authoring technical content of regulatory submissions and capable of leading a CMC sub-team in preparation of submissions.
- Experience and knowledge in the preparation of electronic submissions.
- Proven leadership to rapidly adapt strategy to unanticipated changes.
Interpersonal and Soft Skills:
- Ability to work independently
- Excellent written and communication skills and attention to detail
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts including process development, analytical, manufacturing, quality, and supply chain
- Must be detail oriented and can deal with frequent changes in product activity
- Must be comfortable in a small company environment. Able to be flexible and comfortable with ambiguity.
This is an onsite position in the San Francisco Bay Area and this individual must be onsite 2-3 days a week.
The budgeted salary range for this position is US$250,000 to $320,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of remuneration.