Senior Regulatory Affairs Consultant – Small Molecules and Biologics
Parexel
full-time
Posted on:
Location Type: Remote
Location: New York • United States
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Job Level
About the role
- Provide regulatory strategy input for small molecule and biologic products
- Support regulatory leads in developing contingency plans for CMC-related scenarios
- Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
- Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
- Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes
- Partner with manufacturing, quality, and external organizations to address CMC-related issues
- Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
- Support planning and execution of Health Authority meetings, including mock sessions
- Identify and implement process improvements to enhance regulatory efficiency and readiness
- Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions
- Ensure audit readiness and version control through meticulous documentation and system management
Requirements
- 4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
- Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
- In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics. Previous experience with combination device products is a plus!
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
- Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred
- RAC certification is a plus
Benefits
- Health insurance
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategyCMC-related documentationGMPregulatory submissionsprocess improvementsaudit readinessversion controldrug developmentmanufacturing processesregulatory frameworks
Soft Skills
collaborative relationshipscommunicationcross-functional collaborationorganizational skillsproblem-solvingplanningexecutionstakeholder managementleadershipadaptability
Certifications
RAC certification