Director Regulatory CMC
Proclinical is currently recruiting for a Director of CMC Regulatory Affairs for a global biotechnology company located in Seattle, WA. As the CMC Regulatory Affairs Director, you will develop and implement CMC regulatory strategy in support of the company's programs from pre-IND stage through late stage development.
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
- Independently provide phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for ADC clinical trial applications and marketing applications for development projects.
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Independently manage and prioritize Phase 1 IND and late stage projects.
- Identify, communicate, and propose resolutions to both routine and complex issues.
- Interpret global regulations and guidance. Identify regulatory opportunity and risks across development lifecycle.
- Prepare and manage CMC submissions globally while ensuring thoroughness, completeness and timeliness working in collaboration with SME's in Research, Process Development, Manufacturing, Quality and Supply Chain. Maintain responsibility for all CMC Regulatory timelines.
- Create and maintain regulatory strategy documents, including response strategy assessments for HA interactions.
- Manage relationships with diverse internal and external teams.
- Utilize electronic systems for dossier creation and tracking.
Skills and Requirements:
- BS/BA degree (or equivalent) in a relevant scientific field required, with a PhD in engineering or life sciences preferred.
- 10+ years of experience in roles in the biotech and/or pharmaceutical industry requiring knowledge of biologic manufacturing processes, cGMP principles, and related FDA and other regulatory guidelines, including 3 years of experience in management/leadership roles.
- 5-7 years of regulatory CMC experience required.
- Knowledge of CMC regulatory requirements across development stages and post-approval is essential. Experience with global CMC regulations for biologics is required; experience with antibody drug conjugates preferred.
- Detail-oriented while also retaining the ability to see the big picture.
- Flexible with demonstrated ability to work in a fast-paced, timeline-driven environment.
- Excellent problem-solving and decision-making skills; provides strong critical thinking and constructive feedback.
- Proven ability to effectively collaborate with internal team and external collaborators.
- Will work tirelessly to foster an environment of transparency and direct dialogue.
- A strong team player with a passion for science and helping discover and develop novel therapies for unmet medical needs.
If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.