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

Organon•Florham Park, NJ

1d•Remote

About The Position

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

Requirements

Bachelor’s degree in a science, engineering, or related field and at least 7 years of relevant experience in biological or 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.
Proficiency in English.
Proven ability to critically review detailed scientific information, assess technical merits and the suitability of scientific rationales, and ensure conclusions are clearly presented and adequately supported by data.
Superior oral and written communication skills in multicultural settings, including the 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 creative and imaginative problem-solving ability.
Ability to generate innovative solutions to complex regulatory problems and communicate and work 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.
Ability to satisfy applicable travel and credentialing requirements, including associated vaccination prerequisites.

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 regulatory milestones throughout each product’s lifecycle.
Lead development and execution of global product and project regulatory strategies, assessing CMC changes, identifying global regulatory requirements, evaluating supporting documentation, and identifying potential risks.
Develop, author, and review 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-licensing and due diligence reviews, divestments, and withdrawals.
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.
Lead direct or matrixed colleagues, and potentially outsourcing partners, to meet business commitments and project timelines.