Senior Regulatory Affairs Specialist

Pace® Labs

. Lead and execute global regulatory strategies for investigational, new, and marketed products .

Posted 9/21/2026part-timeRemote • United StatesSenior💰 $85 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in global regulatory strategies and compliance for investigational and marketed products, with a strong focus on CMC documentation and regulatory interactions. Proficient in managing complex deliverables and timelines while ensuring adherence to regulatory requirements.

Highest-signal resume keywords

CMC Regulatory AffairsIND AuthoringRegulatory ComplianceGlobal Health Authority InteractionsRegulatory Document Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Section CompilationTechnical WritingRegulatory Strategy DevelopmentRegulatory Guidelines KnowledgeClinical Trial Support

Soft Skills

Attention to DetailOrganizational SkillsCommunication SkillsTime Management

Tools & Technologies

Regulatory Document Management Systems

Industry Keywords

FDAEMAICHINDIMPDCTARegulatory FilingsStability ReportsComparability ProtocolsPharmaceutical Field

About the role

Key responsibilities & impact

Lead and execute global regulatory strategies for investigational, new, and marketed products
Advise clients on regulatory compliance, stakeholder influence, and business outcomes
Author and compile CMC sections of INDs, IMPDs, CTAs, amendments, and annual reports
Draft and maintain Module 2 and 3 summaries, stability reports, and comparability protocols
Prepare responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities
Prepare and lead regulatory interactions supporting clinical trial initiation and advancement
Develop templates, processes, and workflows for efficient and compliant CMC regulatory operations
Perform other duties as assigned

Requirements

What you’ll need

B.A., M.S., or Ph.D. in biochemistry, chemistry, biology, or related pharmaceutical field
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

Comp & perks

Medical, dental, and vision benefits
401K retirement savings plan with 100% immediate vesting in the employer match
Life insurance
Disability benefits
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 protection