Associate Principal Scientist, Regulatory Affairs - CMC

State of Oregon • Jersey City, NJ

19h • Hybrid

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. It may include managing 1 to 2 individual contributors and/or outsourcing partners and supporting project-team goals and organizational initiatives as needed.

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.
• Proven ability to critically review detailed scientific information, assess technical merits and scientific rationale, 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.
• 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 the 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, review of supporting documentation, and identification of 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 execution and regulatory conformance.
• Manage execution of CMC documentation in accordance with established business processes and systems.
• Apply regulatory affairs knowledge to support approval and product 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.

Benefits

• Retirement savings plan
• Paid vacation and holiday time
• Paid caregiver/parental and medical leave
• Medical, prescription drug, dental, and vision coverage

What This Job Offers

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