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 10/27/2026full-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 for small molecule and biological products, with a strong focus on lifecycle management, regulatory submissions, and risk assessment. Proven leadership in managing teams and collaborating with cross-functional partners to achieve regulatory milestones.

Highest-signal resume keywords

Regulatory CMC Strategy DevelopmentCMC Submission PreparationLifecycle Management ExperienceLeadership and Team ManagementScientific Information Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission ComponentsCMC Dossier PreparationRegulatory Risk AssessmentBiological/Pharmaceutical ResearchManufacturing and Quality Assurance Knowledge

Soft Skills

Superior Oral and Written CommunicationInterpersonal SkillsNegotiation SkillsFlexibility in PrioritizationInnovative Problem Solving

Industry Keywords

Regulatory MilestonesPost-Approval ChangesDue Diligence ReviewsHealth Authority CommunicationChange Management

About the role

Key responsibilities & impact

Develop and implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products
Serve as CMC Product Lead and deliver regulatory milestones throughout the product lifecycle
Lead global product and project regulatory strategies
Develop, author, and review CMC submission components and documentation
Prepare and submit CMC dossiers for lifecycle maintenance submissions, original registrations, and post-approval changes
Support post-approval supplements, annual reports, registration renewals, and responses to health authority questions
Provide regulatory leadership for product in-license/due diligence reviews, divestments, and withdrawals
Collaborate with Manufacturing & Supply colleagues and external partners on compliant change management
Assess and communicate regulatory risks and propose mitigation strategies
Identify, communicate, and escalate regulatory issues to Regulatory CMC management
Manage a team of 1 to 2 individual contributors and/or outsourcing partners as needed
Support project team goals and organizational initiatives

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
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
Understanding of related fields such as manufacturing, analytical, and quality assurance
Ability to generate innovative solutions to complex regulatory problems
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 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