Senior Principal Scientist driving nonclinical safety strategies for Degrader - Antibody Conjugate programs at Orum Therapeutics. Overseeing nonclinical toxicology studies and collaborating with cross - functional teams.
OR
Hybrid Principal Scientist, Regulatory Affairs – Chemistry, Manufacturing and Controls
Posted 5 months ago
About the role
- Principal Scientist leading Regulatory CMC initiatives in a fast-paced environment at Organon. Overseeing aspects from clinical phase to post-approval lifecycle management.
Responsibilities
- Responsible for Regulatory Chemistry Manufacturing and Controls (CMC) aspects of projects in clinical phase through initial product registration and post approval life cycle management
- Partner with Research & Development, Manufacturing & Supply, Business Development, and Commercial to embed an adaptable process
- Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions
- Enable implementation of regulatory CMC strategies to ensure high quality, accuracy, and high likelihood of approval of all regulatory submissions
- Responsible to ensure that regulatory requirements are met and systems/processes are executed in a manner to provide visibility to accurate regulatory information
Requirements
- Bachelor’s degree in a science, engineering, or a related field
- At least ten years of relevant experience including biological/pharmaceutical/device research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph.D., PharmD) with at least five years of relevant experience
- Minimum ten years pharmaceutical or related industry experience
- Minimum five years working in Regulatory CMC, with progressive experience in leading global development-phase programs.
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
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