Senior Manager, Regulatory Affairs
New
S
Spyre TherapeuticsBiotechnology
US- RemoteFull-TimeManager
Salary$160,000 to $176,000
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Job Details
- Experience
- 5-7+ years
- Required Skills
- Project Management
Requirements
- Bachelor’s degree required; advanced degree in a related discipline is a plus.
- 5-7+ years of experience in pharmaceutical regulatory affairs.
- Demonstrated experience contributing to study-level regulatory strategies and submission planning.
- Experience managing clinical regulatory submissions in the US, EU, and globally.
- Proven experience in CRO and vendor oversight for regulatory activities.
- Strong knowledge of global regulations including FDA, EMA, and ICH requirements.
- Proficiency in regulatory/technical writing for documents like protocols, DSURs, and safety reports.
- Experience using regulatory document management systems like Veeva RIM.
- Proficiency in project management tools such as Smartsheet or Excel.
- Familiarity with combination product/device considerations is a plus.
Responsibilities
- Support the development and implementation of regulatory strategies for assigned studies.
- Create and maintain submission plans, country-level timelines, and document requirements for global study start-up.
- Coordinate the preparation and review of clinical documents including protocols, amendments, informed consent, and briefing documents.
- Prepare, compile, and coordinate clinical trial applications and submissions to global health authorities like FDA and EMA.
- Manage regulatory activities performed by CROs and vendors, ensuring quality and adherence to timelines.
- Support health authority interactions by coordinating cross-functional input and managing response development.
- Anticipate regulatory risks and bottlenecks, providing mitigation strategies to leadership.
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