Associate Principal Scientist supporting regulatory strategies for Vaccine & Infectious Disease products. Collaborating globally and assisting submissions for regulatory compliance in the pharmaceutical industry.
SI
Onsite Associate Principal Scientist – Regulatory Chemistry, Manufacturing and Controls (CMC) Product Lead
Posted yesterday
About the role
- Associate Principal Scientist responsible for developing and implementing regulatory CMC strategies at Organon. Leading the preparation and submission of CMC dossiers for product lifecycle milestones.
Responsibilities
- Serve as the CMC Product Lead for assigned products
- Lead development and execution of global product and project regulatory strategies
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation
- Provide regulatory leadership as needed to product in-license/due diligence review
- Collaborate with Organon Manufacturing & Supply colleagues and external partners
- Manage execution of CMC documentation including post-approval supplements and annual reports
- Assess and communicate potential regulatory risks and propose mitigation strategies
- Identify, communicate and escalate potential regulatory issues to management as needed
Requirements
- Bachelor’s degree in a science, engineering, or a related field
- At least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of relevant experience
- Proficient in English; additional language skills are a plus
- Proven experience in critically reviewing detailed scientific information
- Demonstrated superior oral and written communication skills
- Strong listening skills
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance)
Benefits
- Retirement savings plan
- Paid vacation and holiday time
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental, and vision coverage
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Senior Research & Innovation Assistant focused on sustainable solutions for polymers and textiles at Solvay. Collaborating with a diverse scientific community to enhance innovative practices.
Senior Research Scientist for circuit technology development at NVIDIA. Collaborating with elite researchers to advance high - performance, low - power circuit technologies.
Research Assistant supporting negotiation of physician managed care contracts and ensuring compliance standards. Managing processes for tracking insurance payor issues and coordination of meetings.
Senior Scientist, Statistical Genetics at Novo Nordisk Research Center China. Leveraging human genetic evidence to inform drug discovery and portfolio decisions in a collaborative research environment.
Research Assistant supporting sustainable agriculture research and outreach programs at University of Maine. Involves field, greenhouse, and laboratory management along with educational outreach efforts.
Research Assistant contributing to the Discovering Liveability project for suicide prevention. Focused on innovative research centering lived experiences of suicide over a fixed - term of 5 years.
Applied Scientist leading the development of generative AI for Adobe Creative Cloud. Focusing on graphics and vector - based design workflows with advanced machine learning techniques.
Senior Applied Scientist developing production - grade language generation systems with a focus on neurosymbolic AI at UnlikelyAI. Collaborating with a world - class team on innovative AI technologies.
Staff Applied Scientist at UnlikelyAI focusing on research in neurosymbolic AI and leading projects from ideation to deployment.