Manager, Regulatory Affairs - CMC

Position Summary

The Manager CMC Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early and late-stage T cell therapies. This position is hybrid and reports to the Sr. Director, CMC Regulatory Affairs.

Responsibilities

• Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams.
• Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / Master Files, amendments, annual reports) and health authority interaction briefing documents. Manage and maintain regulatory dossiers as required throughout the product development lifecycle.
• Provide review and compilation and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
• Represent CMC regulatory affairs on product teams and in health authority interactions.
• Provide regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises.
• Support the development and maintenance of regulatory templates, best practices, and procedures.
• Perform other responsibilities.

Supervisory Responsibilities

• Support hiring, leading and managing workflow.

Education and Experience

• BA/BS degree in life sciences required, advanced degree preferred (PhD,MS, PharmD).
• Experience of 8+ years with BS/BA; 6+ years with MS/MA or MBA; 5+ years with PhD.
• Prior experience in cell/gene therapy.
• In depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
• Experience in IND, IMPD, BLA, MAA filings.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $126,000 to $174,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.

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