Location : Foster City, CA (Hybrid)
Contract : 6-months initial contract
Pay range : $85.00 - $100.00 per hour
Responsibilities :
Prepare quality-related sections of INDs / IMPDs, marketing authorization applications, post-approval variations, renewals, and responses to regulatory agencies for various biologic products.
Collaborate closely with departments outside CMC Regulatory Affairs to define submission strategies and ensure dossiers comply with ICH guidelines and local regulatory requirements.
- Serve as the regional CMC Regulatory lead for assigned products and markets, contributing to global regulatory strategies within a global matrix team, focusing on international markets.
- Work with teams across Regulatory Affairs, Affiliates, Regulatory Operations, Regulatory Project Management, and third-party agents to create filing plans and meet submission timelines and priorities.
- Coordinate regulatory assessments for post-approval CMC changes, developing and executing filing strategies for assigned markets based on agreed priorities.
- Stay updated on CMC registration requirements across international regions and provide timely regulatory intelligence to the organization.
Qualifications :
- Bachelor's, Master's, or Ph.D. degree or equivalent education.
- Minimum of 2-3 years of experience in Regulatory Affairs CMC or a related pharmaceutical industry role.
- Experience in preparing CMC components for MAA submissions or post-approval variations for small molecule or biologic products.
- Background in biologics or drug-device combination products is a plus.
- Proven ability to manage the preparation of CMC regulatory documents in collaboration with cross-functional teams.
- Strong strategic thinking skills with a track record of developing global CMC regulatory strategies across multiple markets.
- Deep knowledge of ICH and regional CMC regulatory requirements, along with awareness of global and regional trends in CMC Regulatory Affairs.
- Experience representing CMC Regulatory Affairs on cross-functional and regulatory teams.
- Excellent written and verbal communication skills.
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