Senior Director, Regulatory Affairs – CMC & Reg. Sciences
OWP Pharmaceuticals
full-time
Posted on:
Location Type: Hybrid
Location: Chicago • Illinois • United States
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Salary
💰 $230,000 - $290,000 per year
Job Level
About the role
- Manage RA deliverables for biosimilar projects
- Pursue regulatory excellence and optimize cross-functional work processes in submissions
- Track and interpret new guidance and requirements for biosimilars
- Represent the regulatory function on cross-functional teams for biosimilars
- Prepare, review meeting packages and submissions to US FDA
- Lead preparation and manage meetings with health authorities
- Serve as an interface with other partners and consulting services
- Contribute to launch readiness and marketing by guiding project teams
- Provide due diligence and review documents from global business partners
- Contribute to portfolio and pipeline selection and prioritization
- Work closely with management team to identify gaps and build competence for biosimilars
- Provide training on CMC and regulatory sciences for biologics and biosimilars
Requirements
- Master or Ph.D.'s degree in life sciences
- Over 10 years related experience in pharmaceutical or biotech industry
- Minimum of 5 years in management/supervisory roles
- Expertise in biologics/biosimilars and/or combination products
- Experience with multiple cultural, global working teams
Benefits
- Competitive pay and medical, dental, and vision insurance
- Flexible spending accounts
- Long- and short-term disability insurance, as well as life insurance
- 401(k) plan with match
- Competitive PTO and company-paid holidays
- Paid parental leave (maternity & paternity)
- Onsite gym
- Hybrid work schedule
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsbiosimilarsbiologicsCMCproject managementdue diligenceguidance interpretationportfolio selectionpipeline prioritizationcross-functional collaboration
Soft Skills
leadershipcommunicationtrainingorganizational skillsinterpersonal skillsteamworkproblem-solvingstrategic thinkingadaptabilitycultural awareness
Certifications
Master's degreePh.D. degree