Associate Principal Scientist, Regulatory Affairs, Chemistry, Manufacturing, and Control
Organon
Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control – Product Lead
Organon
full-time
Posted on:
Location Type: Hybrid
Location: Jersey City • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $125,400 - $213,100 per year
Job Level
Senior
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategyCMC submission componentsbiological researchpharmaceutical researchmanufacturinganalytical testingproject managementrisk assessmentdocumentation managementdue diligence
Soft skills
leadershipcommunicationcollaborationlisteningcritical reviewmulticultural communicationproblem-solvingstrategic thinkinginterpersonal skillsadaptability
Certifications
Bachelor's degreeMaster's degreeMBAPh.D.PharmD
