Pace® Analytical Services · 5 hours ago
Senior Regulatory Affairs Specialist (Remote)
United States
Full-time
Remote
Senior Level, Lead/Staff
$150K/yr - $175K/yr
10+ years expPace® Analytical Services is dedicated to improving health and safety in communities through innovative science. The Senior Regulatory Affairs Specialist will lead and execute global regulatory strategies, ensuring compliance for investigational and marketed products while serving as a strategic advisor to clients.
Health CareLife ScienceMedical
Responsibilities
Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports
Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols
Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities
Prepare and Lead Regulatory interactions for CMC regulatory strategies to support clinical trial initiation and advancement
Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations
Other duties as assigned
Qualification
Required
B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology, or related pharmaceutical field with a minimum of 10+ years of experience in CMC / regulatory affairs
Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings
Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH
Excellent attention to detail, technical writing, organizational, and communication skills
Ability to manage multiple deliverables and timelines in a fast-paced environment
Proficiency with regulatory document management systems
Benefits
Medical
Dental vision
401K retirement savings plan (100% vested immediately in the employer match)
Life
Disability and voluntary benefits
Paid time off for holiday
Sick and vacation days
HSA
Wellness program
Flexible spending accounts
Tuition reimbursement
Employee Assistance program
Parental leave
Optional legal coverage
ID theft
Company
Pace® Analytical Services
Pace® Science and Technology Company makes the world a safer, healthier place.
1001-5000 employees
H1B Sponsorship
Pace® Analytical Services 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 (4)
2024 (3)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Michael Hausman
Chief Financial Officer
Recent News
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