Regulatory Affairs Professional – Nuvation Bio
Overview:
As part of Nuvation Bio’s Regulatory Affairs team, this role leads and supports regulatory strategy and submissions for clinical and commercial-stage oncology programs. The position involves hands-on management of regulatory documents, communications with global health authorities, and cross-functional collaboration to ensure compliance and successful product advancement.
Key Responsibilities:
- Serve as regulatory lead on drug development teams, developing and executing regulatory strategies.
- Manage, plan, and prepare submissions (INDs, NDAs, DMFs, CTAs, amendments, safety reports, annual updates).
- Communicate directly with U.S. and international regulatory agencies.
- Interpret and convey regulatory expectations to internal teams and external partners (CROs, CMOs, consultants).
- Contribute to pharmacovigilance and compliance activities.
Qualifications:
- Bachelor’s or Master’s degree; 10+ years of regulatory affairs/drug development experience in biopharma.
- Deep knowledge of FDA regulations and experience supporting global clinical studies.
- Expertise with eCTD, e-publishing systems, and regulatory submissions.
- NDA experience required; global marketing application experience (MAA, NDS) preferred.
- Strong communication, leadership, and organizational skills; Boston area preferred.
Core Competencies:
Strategic, collaborative, and detail-oriented professional with strong problem-solving, accountability, adaptability, and communication skills.
Benefits:
Competitive salary, bonus, equity, unlimited vacation, 10 sick days, comprehensive medical coverage, and 401(k) with company match.
Job sourced from Nuvation Bio.