Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control
About The Position
Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Project Lead and provide CMC leadership within Regulatory and on cross-functional teams for the assigned biological projects. Be accountable for the delivery of all regulatory milestones through product development and / or post approval life cycle. Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory Chemistry, Manufacturing and Control requirements and identification of potential risks. Manage execution of CMC documentation including Investigational New Drug Applications, Investigational Medicinal Product Dossiers, original Biologics License Applications, Marketing Authorization Applications, or Post approval / variations, agency background packages and responses to health authority questions per established business processes and systems. Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety Chemistry, Manufacturing and Control management, as needed. Conduct all activities with an unwavering focus on compliance.
Requirements
- B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
- 5 years of Regulatory CMC related experience, relevant experience including biological or vaccine drug substance/drug product development research, or manufacturing, testing and/or related field.
- Adaptability
- Biologics
- Biology
- Biotechnology
- Detail-Oriented
- Document Coordination
- Electronic Common Technical Document (eCTD)
- Employee Training Programs
- Interpersonal Relationships
- Legal Compliance
- Operational Compliance
- Pharmaceutical Industry
- Pharmaceutics
- Product Compliance
- Regulatory Affairs Management
- Regulatory CMC
- Regulatory Communications
- Regulatory Compliance
- Regulatory Compliance Audits
- Regulatory Documents
- Regulatory Experience
- Regulatory Interpretation
- Regulatory Management
- Regulatory Operations
Nice To Haves
- Experience in biologics Regulatory CMC preferred.
Responsibilities
- Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Project Lead and provide CMC leadership within Regulatory and on cross-functional teams for the assigned biological projects.
- Be accountable for the delivery of all regulatory milestones through product development and / or post approval life cycle.
- Ensure development of robust CMC regulatory strategies for assigned projects.
- Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory Chemistry, Manufacturing and Control requirements and identification of potential risks.
- Manage execution of CMC documentation including Investigational New Drug Applications, Investigational Medicinal Product Dossiers, original Biologics License Applications, Marketing Authorization Applications, or Post approval / variations, agency background packages and responses to health authority questions per established business processes and systems.
- Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety Chemistry, Manufacturing and Control management, as needed.
- Conduct all activities with an unwavering focus on compliance.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Senior
