Associate Principal Scientist, Regulatory Affairs - CMC
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 lifecycle maintenance submissions, original registrations, and post-approval changes. The incumbent may manage a team of 1 to 2 individual contributors and/or outsourcing partners and may support project team goals and organizational initiatives as needed. The position serves as CMC Product Lead for assigned products, delivering regulatory milestones throughout the product lifecycle. It provides regulatory leadership for product and project strategy, assessment of CMC changes and risks, preparation and review of submission components, and collaboration with manufacturing, supply, and external partners to ensure regulatory compliance and product supply continuity. The role may also support product in-license and due diligence reviews, divestments, and withdrawals.
Requirements
- Bachelor’s degree in a science, engineering, or related field and at least 7 years of relevant experience in biological/pharmaceutical research, manufacturing, testing, or a related field; alternatively, an advanced degree (MS, MBA, Ph.D., or PharmD) and at least 4 years of relevant experience.
- Proficiency in English.
- Experience critically reviewing detailed scientific information, assessing technical merits and suitability of scientific rationale, and ensuring conclusions are clearly presented and supported by data.
- Strong oral and written communication skills in multicultural settings, including the ability to communicate complex issues succinctly and logically; strong listening skills.
- Sound understanding of related fields such as manufacturing, analytical, and quality assurance, with creative and imaginative problem-solving ability.
- 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.
- Must satisfy applicable travel and credentialing requirements, including associated vaccination prerequisites.
Nice To Haves
- Additional language skills.
- Experience in Regulatory CMC post-approval lifecycle management.
Responsibilities
- Serve as CMC Product Lead for assigned products and deliver regulatory milestones throughout the product lifecycle.
- Lead development and execution of global product and project regulatory strategies, including assessment of CMC changes, global requirements, supporting documentation, and potential 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 for product in-license and due diligence reviews, product divestment, and product withdrawal, as needed.
- 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 regulatory risks and propose mitigation strategies.
- Identify, communicate, and escalate potential regulatory issues to Organon Regulatory CMC management, as needed.
- May manage 1 to 2 individual contributors and/or outsourcing partners in support of project execution.
- Support project team goals and organizational initiatives, as needed.
Benefits
- Retirement savings plan
- Paid vacation and holiday time
- Paid caregiver/parental and medical leave
- Medical, prescription drug, dental, and vision coverage in accordance with applicable plan terms and conditions
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What This Job Offers
Job Type
Full-time
Career Level
Senior
