Remote Regulatory CMC Manager

Summary

Join Orca Bio as a Regulatory CMC Manager to support the development and execution of regulatory strategies within Regulatory Affairs, working closely with CMC and Quality teams to ensure alignment with development milestones and regulatory compliance.

Requirements

• Bachelor’s degree (or equivalent) in life sciences; advanced degree preferred
• 5+ years of experience in the biotech/pharmaceutical industry
• 4+ years of experience in CMC regulatory affairs within pharma or biotech, preferably within cell therapies
• Knowledge of cGMP, CMC regulatory requirements, both domestic and global
• Strong scientific writing skills, with an emphasis on preparing high-quality regulatory packages (BLA/late stage submissions preferred)
• Ability to work effectively in cross-functional teams with a collaborative and hands-on approach
• Initiative-taking and able to manage multiple tasks independently
• Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc

Responsibilities

• Lead the authoring and preparation of meeting packages for regulatory CMC interactions in the US and globally
• Develop and review content for Mod 3 and assist with Mod 2.3 for BLA/MAA filings
• Support the development of CMC regulatory strategies for Orca Bio products (early- to late-stage/registration/post-market)
• Work with cross-functional teams to ensure regulatory packages align with overall development objectives and timelines
• Identify and communicate regulatory risks, supporting the development of strategies to mitigate risks
• Monitor regulatory agency activities related to CMC development and assess potential impacts on Orca Bio programs
• Assist in evaluating proposed manufacturing changes for global impact and contribute to strategic regulatory strategies
• Participate as a CMC Regulatory representative on cross-functional project teams to support project milestones
• Serve as a regulatory contact for Contract Manufacturing Organizations (CMOs) and support interactions with Qualified Persons
• Support the planning, coordination, and development of CMC (Quality) regulatory submissions, ensuring compliance with current regulatory requirements and guidance