Director, Regulatory Affairs CMC
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full-time
Posted on:
Location Type: Remote
Location: Illinois • United States
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Salary
💰 $225,000 - $255,000 per year
Job Level
About the role
- Responsible for providing regulatory strategic support for global regulatory activities for innovative biologics
- Serve as regulatory CMC representative on development and marketed product teams
- Manage interactions with Health Authorities for assigned project(s)
- Coordinate preparation and review technical reports and CMC sections of global submissions
- Ensure compliance with regulatory requirements and strategies
- Maintain knowledge of global competitive landscape and regulatory environment
Requirements
- Accredited bachelor's degree
- Minimum of eight (8) years of experience in the Pharmaceutical, Biotech or Medical Device Industry with direct experience with small molecule/biologic technical functions
- Minimum of five (5) years of experience in Regulatory CMC with progressive experience in supporting global programs from pre-approval or post-marketing
- Capability to interact with CMC technical experts regarding process development and analytical issues
- Demonstrated success in global submission filing, approval, and lifecycle management
- Demonstrated ability to proactively and effectively influence peers, external colleagues, and across all levels of management.
Benefits
- flexible paid time off (PTO)
- health benefits to include Medical, Dental and Vision
- company match 401k
- eligibility for a 25% bonus target based on company and individual performance
- eligibility to participate in the company’s long-term incentive plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategic supportregulatory CMCglobal submissionstechnical reportscompliance with regulatory requirementsprocess developmentanalytical issuesglobal submission filinglifecycle management
Soft Skills
influencing peerscommunication across management levelsproactive engagement
Certifications
accredited bachelor's degree