Manager, CMC Regulatory Affairs – Biologics

Regeneron

. Lead CMC regulatory strategies for assigned biologic products .

Posted 10/14/2026full-timeRensselaer • New York • United StatesMid-LevelSenior💰 $108,000 - $176,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in CMC Regulatory Affairs, including the development and submission of marketing authorizations and post-approval submissions for biologic products. Proven ability to lead regulatory strategies, engage with regulatory authorities, and enhance compliance through effective documentation and training.

Highest-signal resume keywords

CMC Regulatory Affairs ExperienceGlobal CMC Regulatory RequirementsBiologic Product KnowledgeRegulatory Authority EngagementStrong Communication Skills

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Filing ReviewCMC Development SupportMarketing Authorization DeliveryCTA/IND Submission ExperienceRegulatory Impact Assessment

Soft Skills

Strategic ThinkingProblem-SolvingNegotiation SkillsCross-Functional Partnership BuildingTraining and Knowledge Gap Addressing

Tools & Technologies

SOP DevelopmentWorking InstructionsReviewer’s Guides

Industry Keywords

PharmaceuticalBiotechnologyHealth AuthorityRegulatory CompliancePost-Market Activities

About the role

Key responsibilities & impact

Lead CMC regulatory strategies for assigned biologic products
Support CMC development through early phase, submission, and post-market activities
Assess changes and deviations for regulatory impact and filing requirements
Review regulatory filings for compliance with applicable regulations and guidelines
Support regulatory authority interactions, including meetings and information request responses
Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency
Identify regulatory process gaps and recommend efficiency improvements
Translate ambiguity into actionable steps and build alignment across teams
Support training activities and proactively address technical or regulatory knowledge gaps
Collaborate with Global Regulatory Affairs and CMC collaborators

Requirements

What you’ll need

Bachelor’s degree with 6+ years, or advanced degree with 3+ years, in pharmaceutical, biotechnology, or Health Authority settings
2-4 years of CMC Regulatory Affairs experience with worldwide regulations
Strong understanding of global CMC Regulatory Affairs requirements
Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions
Experience supporting biologic products preferred
Experience engaging with FDA or other regulatory authorities preferred
Strong communication, negotiation, strategic thinking, and problem-solving skills
Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments
Ability to support training activities and proactively address technical or regulatory knowledge gaps
Ability to pass applicable background checks
Right to work in the country where the position is based

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life, and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required