Job Title: Associate Principal Scientist (Associate Director), Regulatory CMC – New Products
Overview
As a key member of Organon's Regulatory CMC New Products team, the Associate Principal Scientist (Associate Director) will report to the Director or Executive Director. The role focuses on managing Regulatory Chemistry, Manufacturing & Controls (CMC) for clinical-phase to market product registrations across a portfolio that includes small molecules, biologics, biosimilars, and combination products. This position is central to supporting Organon's growth strategy, especially within women’s health and biosimilars. The Associate Principal Scientist will drive regulatory CMC strategies, ensuring efficient development and submission of regulatory filings globally, in collaboration with internal teams and external partners.
Regulatory Strategy & Execution: Collaborate with R&D, Manufacturing, Business Development, and Commercial teams to develop adaptable regulatory CMC strategies and manage clinical study phases, product registration, and associated activities.
Submission Preparation: Lead the preparation, authorship, and submission of relevant regulatory documents (e.g., IND/CTAs, Health Authority packages) for new products, maintaining quality and alignment with product timelines.
Regulatory Compliance: Ensure compliance with regulatory requirements, including CMC changes during development, and incorporate regulatory insights to manage risk effectively.
Data Management & Quality Control: Maintain and review scientific, technical, and regulatory data in all CMC submissions to ensure accuracy and consistency across documentation and correspondence.
Issue Escalation: Identify and report potential regulatory issues to the Organon Regulatory CMC management team.
Collaboration & Leadership: Lead cross-functional teams in regulatory CMC project initiatives, mentor team members, and contribute to achieving organizational goals and project timelines.
Education: Bachelor’s degree in science, engineering, or related fields (e.g., Pharmacy, Chemistry, Biology). Advanced degrees (MS, MBA, Ph.D., PharmD) are highly valued.
Experience: A minimum of 7 years of relevant experience for those with a bachelor’s degree, or 4 years with an advanced degree, ideally in Regulatory CMC, pharmaceutical research, or related fields.
Skills: Strong communication, problem-solving, and analytical skills. Experience in global regulatory submissions, scientific data analysis, and project management is essential.
Language Proficiency: Fluent in English; additional languages are a plus.
Proven experience in regulatory CMC, with an understanding of related fields such as manufacturing, process development, and quality assurance.
Strong interpersonal and leadership abilities, with experience guiding teams in a cross-functional environment.
Organon is a global healthcare company dedicated to providing innovative health solutions that improve lives, especially in women’s health. We are committed to diversity and inclusion and offer equal opportunities to all applicants. Our inclusive environment supports a global team of diverse professionals who work to make a positive impact.
Employment Details
Compensation
In the U.S., the salary range for this role is $124,000 - $210,700 annually, with benefits including a retirement savings plan, health insurance, and paid leave. Global compensation varies by location.
Requisition ID: R527956
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