Senior Manager, Clinical Regulatory Affairs
New
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Umoja BiopharmaBiotechnology, Immunotherapy
Location: Remote; Seattle, Washington, United StatesFull-TimeManager
Salary159,800 - 202,650 USD per year
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Job Details
- Experience
- 5+ years for Senior Manager, 8+ years for Associate Director.
- Required Skills
- GCP
Requirements
- Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field.
- 5+ years (Senior Manager) or 8+ years (Associate Director) of relevant regulatory affairs experience.
- Hands-on experience with FDA submissions including INDs, protocol amendments, annual reports, and briefing packages.
- Experience supporting EU or global clinical trial applications including CTAs and EMA engagement.
- Working knowledge of ICH guidelines, FDA regulations, EU Clinical Trials Regulation, and GCP.
- Ability to interpret regulatory guidance and communicate recommendations to cross-functional teams.
- Strong project management and organizational skills to manage multiple deliverables.
- Ability to work evenings, holidays, and weekends as needed.
- Ability to travel as needed.
Responsibilities
- Support the development and implementation of global clinical regulatory strategies, including early- and mid-stage clinical development plans.
- Contribute to the preparation, review, and submission of regulatory documents such as INDs, CTAs, protocol amendments, and marketing applications.
- Partner with clinical development, clinical operations, medical writing, pharmacovigilance, and CMC teams to ensure high-quality regulatory deliverables.
- Plan and prepare for health authority meetings with the FDA, EMA, and other national competent authorities.
- Provide regulatory input into clinical study designs, protocols, investigator brochures, and safety reports.
- Monitor regulatory requirements and guidance documents relevant to oncology, cell therapy, and gene therapy.
- Support cross-functional teams by identifying regulatory risks and proposing mitigation strategies.
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