Regulatory CMC Product Lead — Associate Principal Scientist

Organon Comercializadora S de RL de C.V; Florham Park (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Organon seeks an Associate Principal Scientist to develop and implement Regulatory CMC strategies for assigned products, leading the preparation and submission of CMC dossiers for lifecycle maintenance, registrations, and post-approval changes. This role may manage a team of 1–2 contributors or outsourcing partners to support project execution.

The candidate will lead global regulatory strategy, assess regulatory requirements, and ensure timely submissions while coordinating with manufacturing

Qualifications

• Bachelor's degree in a science, engineering, or a related field with relevant experience in biological/pharmaceutical research, manufacturing, testing or related field.
• Advanced degree (MS, MBA, Ph.D., PharmD) with relevant experience in the same areas.
• The candidate must be proficient in English; additional language skills are a plus.
• Proven experience in critically reviewing detailed scientific information to assess technical merits and support conclusions with data.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues succinctly.
• Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance) and ability to solve problems creatively.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and communicate with stakeholders.
• Flexibility in responding to changing priorities or unexpected events.
• Demonstrated effective leadership, communication, interpersonal and negotiating skills.
• Ability to lead a team of direct or matrixed colleagues to deliver on commitments.

Responsibilities

• Serve as the CMC Product Lead for assigned products and deliver regulatory milestones through the product lifecycle.
• Lead development and execution of global regulatory strategy for CMC changes and documentation.
• Develop, author, and review CMC submission components for post-approval supplements, annual reports, and registrations.
• Provide regulatory leadership for product in-license/due diligence, divestment, or withdrawal activities.
• Collaborate with Manufacturing & Supply and external partners to ensure compliant change management.
• Manage CMC documentation including post-approval supplements, annual reports, and registrations.
• Apply regulatory knowledge to ensure approval and product supply continuity.
• Assess regulatory risks and propose mitigation strategies.
• Deliver milestones across product lifecycle and escalate issues as needed.

Skills

Proficient in English

Regulatory leadership

Strong communication

Team leadership

Job description

Organon seeks an Associate Principal Scientist to develop and implement Regulatory CMC strategies for assigned products, leading the preparation and submission of CMC dossiers for lifecycle maintenance, registrations, and post-approval changes. This role may manage a team of 1–2 contributors or outsourcing partners to support project execution.

The candidate will lead global regulatory strategy, assess regulatory requirements, and ensure timely submissions while coordinating with manufacturing