Senior Director, Regulatory Affairs CMC

Role Summary

The Sr. Director, Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) will be responsible to ensure that Zenas is executing global regulatory CMC strategies to support clinical development of small molecule drug products. The individual will provide regulatory guidance and lead the development and implementation of short and long-term regulatory strategies for assigned projects and programs. The individual will be responsible to lead the writing and reviewing of CMC sections of regulatory submissions (IND/IMPD/NLA) to meet both global quality expectations and company timelines.

The ideal candidate is a Regulatory Affairs CMC specialist with prior experience with small molecule API and drug products. The Sr. Director, RA CMC participates in a cross-functional team, partners with key internal/external stakeholders in Technical Operations, Quality, and Regulatory Affairs to ensure the scientific data and submissions fulfill agency expectations in a compliant manner. This position will report to the Vice President, Global Regulatory Affairs CMC.

• Lead the development of the regulatory CMC strategy for assigned development products
• Represent RA CMC on development teams and provide direction on the interpretation and application of CMC/Quality regulations and guidance documents.
• Prepare/coordinate/review the CMC content of IND/IMPD/NDA submissions, meeting packages and response to regulatory agency questions and requests.
• Lead teams for assigned CMC submission projects per agreed upon/required timelines.
• Provide strategic and regulatory compliance input on technical protocols, reports, and other source CMC documents.
• Ensure alignment of the regulatory CMC strategy with the corporate objectives through communication and collaboration with internal stakeholders and business partners. Escalate issues to Senior Management that may impact regulatory compliance and continued development of assets.
• Maintain a current knowledge of US and EU regulatory guidance, regulations, and competitive intelligence. Communicate key updates to Senior Management and project teams as appropriate, and ensure Zenas’s regulatory submissions comply with all regulations/guidelines.
• Represent Regulatory Affairs CMC on various cross-functional teams.
• Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
• Perform other regulatory related duties as assigned

• A BS, or advanced degree, preferably in chemistry or life/physical sciences
• A minimum of 12 years regulatory affairs experience (5+ years RA CMC) within the pharmaceutical or biotechnology industry
• Prior experience in developing US and EU global regulatory strategies for small molecule drugs
• Knowledge of small molecule chemistry and development processes
• Prior experience in compiling module 3 CMC sections for IND/IMPD/NDAs
• Experience interacting with key functional stakeholders (product development, manufacturing, QA, QC, supply chain)
• Ability to influence across functions and levels within the organization.
• Self-motivated, self-disciplined and able to function independently as well as part of a team
• Ability to prioritize, multi-task, and work in an evolving and high-pressure environment
• Good presentation and excellent written/verbal communication skills
• Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
• Experience managing people preferred