Regulatory Project Manager
Associate Director, Regulatory Affairs
Location: Remote (East Coast time zone)
Salary Range: $150,000 - $210,000 base
About the Role
A clinical-stage biotech company is seeking an experienced regulatory affairs professional to join its growing team. This role will lead regulatory strategy and execution for key programs, ensuring alignment with global health authorities and driving successful submissions. The ideal candidate is proactive, detail-oriented, and thrives in a fast-paced, cross-functional environment.
Key Responsibilities
- Develop and implement global regulatory strategies for clinical-stage programs.
- Lead regulatory conversations internally and externally, including interactions with FDA and other health authorities.
- Oversee preparation and submission of INDs, NDAs, BLAs, and related regulatory documents.
- Drive regulatory project management, ensuring timelines are met and cross-functional teams remain aligned.
- Hold teams accountable for deliverables and maintain strict adherence to timelines.
- Provide strategic input on clinical development plans, labeling, and risk mitigation.
- Monitor regulatory changes and assess impact on company programs.
- Utilize Smartsheet and Microsoft Project (or similar tools) to track timelines and manage projects effectively.
Qualifications
- 8+ years of regulatory affairs experience in biotech/pharma, with at least 3+ years in a leadership role.
- Proven track record of leading NDA/BLA submissions and regulatory strategy for clinical-stage programs.
- Strong understanding of FDA regulations and global requirements.
- Exceptional cross-functional leadership and communication skills.
- Ability to work independently in a remote environment with high accountability and work ethic.
- Familiarity with Smartsheet and Microsoft Project for project management.
- Therapeutic area experience is flexible; autoimmune or rare disease experience is a plus.
Why Join?
- Opportunity to shape regulatory strategy for innovative therapies.
- Collaborative, mission-driven team focused on improving patient outcomes.
- Competitive compensation, equity, and benefits.
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