Associate Principal Scientist, Regulatory Chemistry Manufacturing – Controls (CMC) Product Lead

Organon

. Develop and implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products .

Posted 11/3/2026full-timeRemote • United States, United Kingdom, BelgiumSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Chemistry, Manufacturing & Controls (CMC) strategies, with a strong focus on lifecycle management and regulatory submissions for biological and small molecule products. Proven ability to lead cross-functional teams and communicate complex regulatory issues effectively.

Highest-signal resume keywords

Regulatory CMC Strategy DevelopmentCMC Dossier PreparationLifecycle ManagementRegulatory Risk AssessmentLeadership in Multicultural Settings

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsBiological ResearchPharmaceutical ManufacturingTechnical Document ReviewAnalytical Quality AssuranceProblem SolvingProject ManagementStakeholder CommunicationChange ManagementPost-Approval Lifecycle Management

Soft Skills

Superior Oral CommunicationWritten CommunicationListening SkillsInterpersonal SkillsNegotiating Skills

Industry Keywords

Regulatory ComplianceHealth Authority InteractionProduct In-License ReviewsDue DiligenceProduct Withdrawal

About the role

Key responsibilities & impact

Develop and implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products
Lead preparation and submission of CMC dossiers for life-cycle maintenance submissions, original registrations, and post-approval changes
Serve as CMC Product Lead for assigned products and deliver all regulatory milestones across the product lifecycle
Lead global product and project regulatory strategies
Assess CMC changes, identify global regulatory requirements, evaluate supporting documentation, and identify potential risks
Lead development, authoring, and review of CMC submission components and documentation
Support post-approval supplements, annual reports, registration renewals, and responses to health authority questions
Provide regulatory leadership for product in-license/due diligence reviews, product divestment, and product withdrawal
Collaborate with Organon Manufacturing & Supply colleagues and external partners on compliant change management
Manage CMC documentation according to established business processes and systems
Assess and communicate regulatory risks and propose mitigation strategies
Identify, communicate, and escalate regulatory issues to Organon Regulatory CMC management
May manage 1 to 2 individual contributors and/or outsourcing partners
Support project team goals and organizational initiatives as needed

Requirements

What you’ll need

Bachelor’s degree in a science, engineering, or related field with at least 7 years of relevant experience, including biological/pharmaceutical research, manufacturing, testing, or a related field
OR advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of relevant experience, including biological/pharmaceutical research, manufacturing, testing, or a related field
Proficient in English; additional language skills are a plus
Proven experience critically reviewing detailed scientific information and assessing technical merits and scientific rationale
Superior oral and written communication skills in multicultural settings
Ability to communicate complex issues succinctly and logically
Strong listening skills
Sound understanding of related fields such as manufacturing, analytical, and quality assurance
Ability to develop creative and imaginative approaches to new and diverse problem solving
Ability to generate innovative solutions to complex regulatory problems
Ability to work with and communicate effectively with key stakeholders
Flexibility in responding to changing priorities or unexpected events
Effective leadership, communication, interpersonal, and negotiating skills
Ability to lead direct or matrixed colleagues to deliver business commitments and project timelines
Experience in Regulatory CMC post-approval lifecycle management preferred
Must be able to satisfy applicable travel and credentialing requirements, including associated vaccination prerequisites
No visa sponsorship

Benefits

Comp & perks

Retirement savings plan
Paid vacation and holiday time
Paid caregiver/parental and medical leave
Health benefits including medical, prescription drug, dental, and vision coverage
Flex Time
Remote Work