Leading device development strategies for drug - device combination products. Collaborating with cross - functional teams from concept to launch while ensuring regulatory compliance.
OR
Hybrid Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control – Product Lead
Posted 3 weeks ago
About the role
- 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 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
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
- At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields
- Proficient in English; additional language skills are a plus.
- Proven experience in critically reviewing detailed scientific information
- Demonstrated superior oral and written communication skills in multicultural settings
- Strong listening skills
- Demonstrated sound understanding of related fields
Benefits
- Health benefits including medical, prescription drug, dental, and vision coverage
- Paid vacation and holiday time
- Paid caregiver/parental and medical leave
- Retirement savings plan
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