- Independently manage content development, compilation, and review of module 3 for regulatory submissions, including IND/Clinical trial applications and BLA applications, ensuring that these documents meet regulatory requirements.
- Lifecycle management of open INDs and CTAs in compliance with regulations.
- Lead CMC related interactions with Health Authorities, including RTQs, meeting participation, and meeting package preparation.
- Independently prepare and manage CMC submissions, working with publishing vendor, with regional consulting leads for international submissions, and partnering with internal SMEs in Research, Process Development, and Manufacturing.
- Development, communication, and execution of phase-appropriate global CMC regulatory strategy to support development projects and business objectives; create and maintain regulatory strategy documents.
- Identification and communication of CMC regulatory risks and impact to timelines; maintain responsibility for CMC regulatory timelines.
- Review and provide regulatory assessments for relevant quality systems such as change controls.
- CMC regulatory diligence for potential partnerships and quality agreements.
- Manage relationships with diverse internal and external teams.
- Utilize electronic systems for document authoring and regulatory submission/communication archiving.
- Accountable for the growth and development of the CMC regulatory team to cover the project portfolio as the company expands.
- Bachelor’s degree in a scientific field.
- A minimum of 10 years of work experience in the pharmaceutical, biotechnology, or related industry and at least 8 years of experience directly in CMC regulatory.
- Experience with biologics is required; experience with oncology, immunotherapies/vaccines, CBER, small molecules, or IVDs are an advantage.
- Mastery of global CMC/GMP regulations (ICH, EMA, FDA).
- Demonstrated successful management of complex regulatory submissions.
- Direct interaction with Health Authorities is required.
- CMC regulatory expertise through all stages of a product’s lifecycle from preclinical through marketing application.
- Ability to perform both tactical and strategic work.
- Strong leader with exceptional written communication skills and attention to detail.
- Comfortable delineating between regulatory requirements and recommendations, appropriate for the phase of development (clinical vs. marketing application).
- A tackler, not a blocker, with a collaborative working style.
Travel: as needed for health authority meetings