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

Organon • Florham Park, NJ

2d • Remote

About The Position

Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist develops and implements regulatory CMC strategies for assigned small-molecule or biological products in accordance with global regulations, guidances, and Organon procedures. The role leads preparation and submission of CMC dossiers for life-cycle maintenance submissions, original registrations, and post-approval changes. The incumbent may manage one or two individual contributors and/or outsourcing partners and may support project-team goals and organizational initiatives as needed.

As CMC Product Lead, the Associate Principal Scientist is accountable for regulatory milestones across assigned products’ lifecycles. The role assesses CMC changes and global regulatory requirements, evaluates supporting documentation and potential risks, and leads development, authoring, and review of CMC submission materials. It also collaborates with manufacturing, supply, and external partners to support compliant change management and continuity of product supply.

Requirements

• Bachelor’s degree in a science, engineering, or related field, such as Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry, and at least 7 years of relevant experience in biological/pharmaceutical research, manufacturing, testing, or a related field; OR an advanced degree (MS, MBA, Ph.D., or PharmD) and at least 4 years of relevant experience in those areas.
• Proficiency in English.
• Experience critically reviewing detailed scientific information, assessing technical merits and the suitability of scientific rationale, and ensuring conclusions are clearly presented and adequately supported by data.
• Superior oral and written communication skills in multicultural settings, ability to communicate complex issues succinctly and logically, and strong listening skills.
• Sound understanding of related fields such as manufacturing, analytical work, and quality assurance, with creativity and imagination in problem solving.
• Ability to generate innovative solutions to complex regulatory problems and work and communicate effectively with key stakeholders.
• Flexibility in responding to changing priorities and unexpected events.
• Effective leadership, communication, interpersonal, and negotiating skills.
• Ability to lead direct or matrixed colleagues to deliver business commitments and project timelines.

Nice To Haves

• Experience in Regulatory CMC post-approval lifecycle management.
• Additional language skills.

Responsibilities

• Serve as CMC Product Lead for assigned products and deliver all regulatory milestones throughout the product lifecycle.
• Lead development and execution of global product and project regulatory strategies, including assessment of CMC changes, identification of global regulatory requirements, critical evaluation of supporting documentation, and identification of risks.
• Lead development, authoring, and review of CMC submission components and documentation for post-approval supplements, annual reports, registration renewals, and responses to health authority questions.
• Provide regulatory leadership, as needed, for product in-license and due-diligence reviews, product divestment, and product withdrawal.
• Collaborate with Organon Manufacturing & Supply colleagues and external partners to support compliant change management and regulatory conformance.
• Manage execution of CMC documentation through established business processes and systems.
• Apply regulatory affairs knowledge to support product approval and continuity of product supply.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Identify, communicate, and escalate potential regulatory issues to Organon Regulatory CMC management as needed.
• Lead direct or matrixed colleagues and/or outsourcing partners to deliver business commitments and project timelines.

Benefits

• Retirement savings plan.
• Paid vacation and holiday time.
• Paid caregiver, parental, and medical leave.
• Health benefits including medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior