Associate Principal Scientist, Regulatory Affairs - CMC

Organon LLC; Jersey City (NJ); Presencial; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

Organon LLC is seeking an Associate Principal Scientist to lead regulatory CMC strategies for assigned products. You will drive global CMC submissions and life-cycle activities, coordinating cross-functionally with manufacturing, quality, and external partners to maintain regulatory conformance.

You will oversee documentation, assess regulatory risks, and contribute to due diligence, licensing, and product lifecycle milestones as part of a dynamic regulatory team.

Formación

• Bachelor’s degree in a science, engineering, or related field.
• Fields of study include Pharmacy, Chemistry, Chemical Engineering, etc.
• Experience developing and governing regulatory CMC strategies is preferred.

Responsabilidades

• Lead development and execution of global CMC regulatory strategy for assigned products.
• Oversee preparation and submission of CMC dossiers for life-cycle and post-approval changes.
• Collaborate with manufacturing and external partners to ensure regulatory conformance.
• Provide regulatory leadership for due diligence, in-licensing, divestment or withdrawal efforts.

Conocimientos

CMC regulatory knowledge

Regulatory strategy leadership

Cross-functional collaboration

Documentation writing

Team leadership

Educación

Bachelor’s degree in science or engineering

Descripción del empleo

Job Description

Job Description The Position Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in accordance with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance submissions, original registrations, and post-approval changes. The incumbent may manage a team of 1 to 2 individual contributors and/or outsourcing partners in support of project execution. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as needed basis.

Responsibilities

Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal. Collaborate with Organon Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle. Identify, communicate and escal ...Potential regulatory issues to Organon Regulatory CMC management, as needed.

Required Education, Experience and Skills

Bachelor’s degree, in a science, engineering, or a related field. Fields of study include Pharmacy, Chemistry, Chemical Engineering,