Senior Manager, Regulatory Affairs
New
A
Apogee TherapeuticsBiotechnology
Location: RemoteFull-TimeManager
Salary$155,000-$175,000
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Job Details
- Experience
- 5 years
- Required Skills
- Project ManagementSharePoint
Requirements
- BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline.
- Minimum of 5 years of regulatory experience in biopharmaceutical drug development.
- Experience interacting with health authorities including FDA and EMA.
- Strong project management skills with a high sense of urgency.
- Ability to collaborate and influence cross-functionally.
- Strong communication skills with experience presenting to diverse stakeholders.
- Proficiency in Veeva Regulatory Information Management (RIM) platforms.
- Experience with eCTD submissions.
- Proficiency in Microsoft Office, SharePoint, and Teams.
- Ability to travel up to 10% of the time, including mandatory in-person All Hands meetings twice per year.
- Regulatory Affairs Certification (RAC) preferred.
Responsibilities
- Lead and coordinate regulatory submissions including INDs, CTAs, NDAs, BLAs, and PIPs/PSPs.
- Support data collection and cross-functional authorship for regulatory documents.
- Proofread, edit, and prepare documentation for regulatory submissions.
- Serve as the primary interface with regulatory publishing for electronic submissions.
- Archive and maintain submissions in the regulatory information management system.
- Implement standardized templates and guidelines for documentation.
- Communicate US and international regulatory requirements to ensure quality submissions.
- Support global regulatory leads on clinical study and execution teams.
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