Apex Systems · 1 week ago
Sr Regulatory Scientist, Solid Oral Phase II & III
United States
Full-time
Remote
Senior Level
$67/hr - $67/hr
7+ years expApex Systems is a world-class IT services company that serves thousands of clients across the globe. They are seeking a Senior Regulatory Scientist to support a global client on a Solid Oral Phase II & III program involving complex, multi-region regulatory workstreams. The role involves executing regulatory strategies and ensuring high-quality clinical trial submission deliverables across the US, EU, and China.
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Responsibilities
Execute regional clinical trial (CT) submission strategies aligned with the global regulatory plan for US, EU, and China
Prepare, review, and coordinate regulatory documents for clinical trial applications, including IND amendments, CTA/CTC submissions, protocol updates, and Investigator’s Brochure (IB) revisions
Lead cross-functional collaboration with CMC, Clinical, Safety, and Project Management teams to ensure cohesive and compliant submission packages
Track regulatory timelines, risks, and dependencies; escalate issues and propose mitigation strategies
Ensure compliance with applicable regional regulations and guidance (FDA, EMA, NMPA) for Phase II & III trials
Respond to health authority queries and support deficiency resolution and follow-up commitments
Maintain submission quality standards, version control, and document integrity for source documents and dossiers
Contribute to regulatory meeting materials (e.g., briefing packages, Q&A grids) and participate in internal readiness reviews
Qualification
Required
7–10+ years of regulatory affairs experience in clinical-stage drug development, with direct responsibility for US, EU, and China CT submissions
Solid experience with solid oral dosage programs strongly preferred
Proven ability to work independently, execute defined strategies, and deliver to aggressive timelines
Strong understanding of Phase II & III regulatory requirements, submission templates, and regional nuances
Excellent project coordination, document management, and stakeholder communication skills
Bachelor's or advanced degree in a life science or related field (MS/PhD preferred)
Benefits
Medical
Dental
Vision
Life
Disability
Other insurance plans
ESPP (employee stock purchase program)
401K program
HSA (Health Savings Account on the HDHP plan)
SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions
Corporate discount savings program
On-demand training program
Access to certification prep
Library of technical and leadership courses/books/seminars
Certification discounts
Other perks to associations that include CompTIA and IIBA
Company
Apex Systems
Apex Systems, a division of On Assignment, provides organizations with IT staffing solutions to address gaps in their current workforce.
1001-5000 employees
H1B Sponsorship
Apex Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (28)
2024 (21)
2023 (35)
2022 (26)
2021 (29)
2020 (38)
Funding
Current Stage
Late StageLeadership Team
Roger Wahman
Chief Technology Officer - SVP
Andrea Schiola
Global Head of Technology Partnerships, SVP, Principal
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