Associate Principal Scientist, Regulatory Affairs Chemistry, Manufacturing, and Control (CMC)

Role Summary

Associate Principal Scientist, Regulatory Affairs Chemistry, Manufacturing, and Control (CMC) responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products, leading the preparation and submission of CMC dossiers for life-cycle maintenance, registrations, and post-approval changes.

Responsibilities

• Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through the product lifecycle.
• Lead development and execution of global product and project regulatory strategy by assessing CMC changes, identifying global regulatory requirements, and evaluating supporting documentation to confirm acceptability and identify risks.
• Develop, author, and review CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals, and responses to health authority questions.
• Provide regulatory leadership for product in-license/due diligence, divestment, and withdrawal when needed.
• Collaborate with Organon Manufacturing & Supply and external partners to support compliant change management with regulatory conformance.
• Manage execution of CMC documentation including post-approval supplements, annual reports, and health authority responses per established processes.
• Apply regulatory knowledge to ensure approval and product supply continuity.
• Assess and communicate regulatory risks and propose mitigation strategies.
• Deliver all regulatory milestones across the product lifecycle.
• Identify, communicate, and escalate regulatory issues to Organon Regulatory CMC management as needed.

Qualifications

• Required: Bachelor‚Äôs degree in a science, engineering, or related field (e.g., Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, Biochemistry) with at least seven years of relevant experience; or Advanced degree (MS, MBA, Ph.D., PharmD) with at least four years of relevant experience.
• Proficient in English; additional languages are a plus.

Skills

• Proven ability to critically review detailed scientific information and present conclusions supported by data.
• Strong oral and written communication skills in multicultural settings; ability to convey complex issues succinctly; strong listening skills.
• Understanding of related fields (manufacturing, analytical, quality assurance) and creative problem-solving abilities.

Leadership

• Ability to generate innovative solutions to complex regulatory problems and communicate with stakeholders.
• Flexibility in changing priorities and handling unexpected events.
• Effective leadership, communication, interpersonal and negotiating skills; ability to lead a team to meet commitments and timelines.

Education

• Preferred: Experience in Regulatory CMC post-approval lifecycle management.