Senior Director, Regulatory Affairs – CMC & Reg. Sciences

Role Overview

• 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