OWP Pharmaceuticals

Compliance

• 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

Senior Director, Regulatory Affairs – CMC & Reg. Sciences

Accountant

• Supports the month end close process.
• Performs accounts receivable functions.
• Analyzes, processes and resolves chargebacks.
• Reviews results on a monthly basis and provides variance analysis.
• Prepares and maintains accounting documentation for complex accounting issues.
• Independently performs one-off projects as delegated.

Senior Director, Regulatory Affairs – CMC & Reg. Sciences

Staff Accountant