Senior Manager/Associate Director, Regulatory Affairs
New
B
BridgeBioBiopharmaceutical drug development
Location: Remote - USA; This is a U.S.-based remote roleFull-TimeManager
Salary$160,000 — $225,000 USD
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Job Details
- Languages
- Proficient in written, oral, and interpersonal communications in English
- Experience
- A minimum of 3 years of industry experience is generally required for the Senior Manager level, with greater experience and scope of responsibility expected at the Associate Director level.
- Required Skills
- GCPMicrosoft Office
Requirements
- Hold a BA/BS degree in biological or physical sciences; an advanced degree such as a PharmD or PhD is preferred.
- Have relevant pharmaceutical industry experience, including regulatory affairs experience.
- For Senior Manager level, generally have at least 3 years of industry experience; Associate Director level requires greater experience and scope.
- Know US FDA and international pharmaceutical guidance and regulations, including 21 CFR, ICH, GCP, GMP, and EMA requirements.
- Understand the drug development process and industry-standard practices.
- Have demonstrated experience supporting eCTD-formatted submissions, such as INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements.
- Have coordinated or supported health authority responses or other critical submission projects while maintaining timelines.
- Collaborate with colleagues across Regulatory and the development organization and provide strategic regulatory guidance.
- Be proficient in written, oral, and interpersonal communications in English.
- Have experience interacting with CROs on US eCTD IND submissions and ex-US CTAs toward clinical trial activations; preferred.
- Be proficient with Microsoft Word, Excel, and PowerPoint.
- Have experience using Veeva electronic document management systems and document review tools.
Responsibilities
- Develop and execute regional regulatory strategies for development programs, including regulatory guidance for product development and registration.
- Plan, compile, review, and submit regulatory documents, including INDs, CTAs, NDAs, amendments, and supplements.
- Represent Regulatory at cross-functional team meetings and provide strategic guidance on study-level decisions.
- Own study-level global regulatory activities, including CTA and IND submissions and investigator document package reviews.
- Track regulatory and ethics submissions and approvals across studies.
- Facilitate FDA and other health authority meetings with Regulatory leadership.
- Coordinate regulatory document planning, review, finalization, and sign-off with project teams.
- Develop and maintain submission timelines and coordinate submissions with CROs and vendors.
- Manage regulatory agency queries and commitments, coordinating written responses and status updates.
- Review critical study documents and maintain regulatory databases, guidance, and SOPs.
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