Manager, CMC Regulatory Affairs – Biologics

Regeneron

. Lead CMC regulatory strategies for assigned biologic products .

Posted 10/27/2026full-timeUnited StatesMid-LevelSenior💰 $108,000 - $176,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC Regulatory Affairs, including leading regulatory strategies for biologic products and ensuring compliance with global regulations. Proficient in developing SOPs and engaging with regulatory authorities to facilitate submissions and address knowledge gaps.

Highest-signal resume keywords

CMC Regulatory Affairs ExperienceGlobal CMC Regulatory RequirementsBiologic Products ExperienceRegulatory Authority EngagementStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

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

Soft Skills

Strategic ThinkingProblem-SolvingNegotiation SkillsCross-Functional Partnership BuildingAdaptability in Dynamic Environments

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 address technical or regulatory knowledge gaps

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
Background checks may verify identity, right to work, and educational qualifications

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