Associate Principal Scientist – Regulatory CMC, Medical Device and Combination Product (MDCP)
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 combination 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 1 to 2 individual contributors and/or outsourcing partners and may support project team goals and organizational initiatives as needed. The Associate Principal Scientist serves as CMC Product Lead for assigned products and is accountable for regulatory milestones across the product lifecycle. The role provides regulatory strategy and leadership for product changes and submissions, assesses and communicates risks, supports compliant change management with manufacturing and external partners, and may contribute to in-license and due-diligence reviews, divestments, and product withdrawals.
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, with the ability to communicate complex issues succinctly and logically, and 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 problems and generate innovative solutions to complex regulatory problems.
- Ability to work effectively with and communicate to 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
- Additional language skills.
- Experience in Regulatory CMC post-approval lifecycle management for small molecule and combination products.
Responsibilities
- Serve as the CMC Product Lead for assigned products and be accountable for delivery of 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, and evaluation of 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 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 for post-approval supplements, annual reports, registration renewals, and responses to health authority questions according to established business processes and systems.
- Apply regulatory affairs understanding to support product approval and supply continuity.
- 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, where applicable, outsourcing partners to deliver business commitments and project timelines.
Benefits
- Retirement savings plan.
- Paid vacation and holiday time.
- Paid caregiver, parental, and medical leave.
- Medical, prescription drug, dental, and vision health benefits, subject to applicable plan terms and conditions.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
