Manager, Combination Products – Regulatory Affairs

Regeneron

. Support combination product development from early phase through post-market activities .

Posted 10/16/2026full-timeRensselaer • New York • United StatesMid-LevelSenior💰 $108,000 - $176,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC Regulatory Affairs with a strong understanding of global regulations for combination products and biologics. Capable of developing quality systems, supporting regulatory submissions, and fostering effective stakeholder partnerships.

Highest-signal resume keywords

CMC Regulatory AffairsRegulatory FilingsCombination ProductsGlobal RegulationsStakeholder Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Impact AssessmentDesign Control DocumentationQuality Systems DevelopmentMarketing AuthorizationsCTA/IND SubmissionsPost-Approval SubmissionsSOP CreationRegulatory IntelligenceBiologics ExperienceFDA Engagement

Soft Skills

CommunicationNegotiationStrategic ThinkingProblem-SolvingCross-Functional Collaboration

Industry Keywords

PharmaceuticalBiotechnologyRegulatory ComplianceHuman FactorsTraining Activities

About the role

Key responsibilities & impact

Support combination product development from early phase through post-market activities
Review regulatory filings including INDs, BLAs, MAAs, annual reports, and supplements
Develop design control documentation and quality systems for combination products
Assess changes and deviations for regulatory impact and submission requirements
Support regulatory authority meetings, responses, and inspections
Create SOPs, Working Instructions, and Reviewer’s Guides
Identify process gaps and support regulatory intelligence activities
Translate ambiguity into action and build effective stakeholder partnerships
Collaborate with Regulatory Affairs, Manufacturing, Quality, and combination product stakeholders
Support training activities and address technical or regulatory knowledge gaps

Requirements

What you’ll need

Bachelor’s degree with 6+ years related experience, or advanced degree with 3+ years related experience in pharmaceutical or biotechnology settings
2–4 years of CMC Regulatory Affairs experience supporting worldwide regulations
Strong understanding of global CMC Regulatory Affairs requirements, including combination products and human factors
Experience delivering marketing authorizations, CTA/INDs, and post-approval submissions
Experience supporting biologics and combination products preferred
Experience engaging with FDA or other regulatory authorities preferred
Ability to assess regulatory impact, support compliance activities, and mentor junior staff
Strong communication, negotiation, strategic thinking, problem-solving, prioritization, and cross-functional collaboration skills
Ability to support training activities and proactively address technical or regulatory knowledge gaps
Must satisfy applicable background checks, including identity, right-to-work, and educational qualification verification

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