Manager, Regulatory Affairs – Biomaterials

Johnson & Johnson

. Develop and execute regulatory strategies for biomaterials, biologics, combination products, and externally sourced innovation opportunities .

Posted 10/16/2026full-timeUnited StatesSeniorLead💰 $117,000 - $201,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates specialized regulatory expertise in CMC and CGMP requirements, with a strong focus on developing and executing regulatory strategies for biomaterials, biologics, and combination products. Proven ability to lead regulatory activities, manage cross-functional collaboration, and ensure compliance with global regulatory standards.

Highest-signal resume keywords

Regulatory Strategy DevelopmentCMC ExpertiseCGMP ComplianceRegulatory SubmissionsCross-Functional Collaboration

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsBLA DevelopmentIDE DevelopmentLifecycle ManagementRegulatory Due DiligenceClinical ProgramsTechnical DocumentationGlobal Change NotificationsCombination ProductsBiologics

Soft Skills

Clear CommunicationLeadershipCoachingIndependent JudgmentTraining Development

Industry Keywords

BiomaterialsMedical DevicePharmaceuticalRegulated HealthcareExternal InnovationBusiness DevelopmentStakeholder EngagementGovernance ForumsRegulatory AuthoritiesClinical Investigation

About the role

Key responsibilities & impact

Develop and execute regulatory strategies for biomaterials, biologics, combination products, and externally sourced innovation opportunities
Provide early-stage regulatory guidance and support due diligence and business development activities
Advance product development, clinical programs, submissions, approvals, launch readiness, and lifecycle management
Lead regulatory activities before global regulatory authorities
Manage Regulatory Affairs activities, establish priorities, and communicate objectives, risks, and recommendations
Prepare and maintain BLAs, IDEs and IDE Supplements, PMAs and PMA Supplements, 510(k)s, De Novo requests, HDEs, annual reports, global change notifications, and technical documentation
Define and execute regulatory strategies for pipeline development, clinical programs, and global launch readiness
Partner with R&D, Quality, Clinical, Medical Affairs, Supply Chain, Commercial, Business Development, and other stakeholders
Exercise independent judgment on complex regulatory issues and drive regulatory deliverables
Provide leadership, coaching, and technical guidance to colleagues and cross-functional teams
Develop and deliver training on regulatory, CMC, CGMP, biologics, combination-product, and clinical investigation requirements
Coordinate communication with global and regional/local regulatory agencies
Ensure company policies, procedures, and practices comply with regulatory requirements
Support timely regulatory approvals and clearances and identify capability gaps and solutions
Lead Regulatory Affairs screening and technical due diligence for external innovation, partnerships, licensing, acquisitions, and business development opportunities
Represent the Biomaterials External Innovation regulatory perspective in governance forums, partner interactions, diligence activities, and regulatory agency engagements

Requirements

What you’ll need

Minimum of a bachelor’s degree in a scientific, engineering, pharmacy, or other relevant technical discipline is required
Minimum of 8 years of relevant experience in the medical device, biologics, pharmaceutical, combination-product, or other regulated healthcare industry is required
Demonstrated experience supporting complex product development programs
Specialized regulatory expertise in CMC and CGMP requirements is required
Demonstrated experience developing and executing regulatory strategies aligned with business objectives is required
Experience with BLA and IDE development, submission, or lifecycle support is strongly preferred
Experience assessing early-stage external innovation, conducting regulatory due diligence, and supporting external partnerships or business development opportunities is strongly preferred
Advanced degree is preferred
Expertise in biologics, biomaterials, combination products, CMC, CGMP, BLA, and IDE requirements
Skills in regulatory submissions, early-stage regulatory strategy, external innovation assessment, regulatory due diligence, and cross-functional collaboration
Clear written and verbal communication

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year