Research Associate at HHL Leipzig Graduate School focusing on economic psychology and leadership. Engaging in research projects while supporting teaching and supervising students' theses.
OR
Hybrid Associate Principal Scientist, Regulatory Affairs, Chemistry, Manufacturing, and Control
Posted 5 months ago
About the role
- Associate Principal Scientist responsible for developing regulatory CMC strategies for small molecule products in women's health at Organon. Leading CMC dossier preparation and submission for global operations.
Responsibilities
- Serve as the CMC Product Lead for assigned products
- Lead development and execution of global product and project regulatory strategy
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components
- Provide regulatory leadership for product in-license/due diligence review
- Collaborate with Organon Manufacturing & Supply colleagues and external partners
Requirements
- Bachelor’s degree in a science, engineering, or a related field
- At least seven 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 four 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
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance)
Benefits
- Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans
- Paid caregiver/parental and medical leave
- Paid vacation and holiday time
- Retirement savings plan
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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