Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control Product Lead

Role Summary

Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Controls Product Lead. Responsible for developing and implementing regulatory CMC strategies for assigned products, leading preparation and submission of CMC dossiers, and delivering regulatory milestones across the product lifecycle.

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 by ensuring robust assessment of CMC changes, identification of global regulatory requirements and evaluation of supporting documentation to confirm acceptability and identify potential 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, product divestment and product withdrawal as needed.
• Collaborate with Manufacturing & Supply colleagues and external partners to support compliant change management and ensure regulatory conformance.
• Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions.
• Demonstrate understanding of regulatory affairs to ensure approval and product supply continuity; assess and communicate regulatory risks and propose mitigation strategies.
• Deliver all regulatory milestones for assigned products across the product lifecycle and escalate issues to Organon Regulatory CMC management as needed.

Qualifications

• 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 7 years of relevant experience OR
• Advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of relevant experience
• At least five years of relevant experience including biological/pharmaceutical research; manufacturing, analytical testing; or related fields
• Proficient in English; additional language skills a plus

Skills

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

Leadership

• Ability to generate innovative solutions to complex regulatory problems and communicate with stakeholders.
• Flexibility in adapting to changing priorities and unexpected events; strong leadership, communication, interpersonal and negotiating skills.
• Ability to lead a team of direct or matrixed colleagues to deliver on commitments and timelines.