Regulatory CMC Manager

About reputed company. reputed company was founded in 2018 with a mission to create reputed company for fertility patients by introducing new therapeutic solutions. We’ve reputed company a robust pipeline of multi-stage assets from early stage to commercialization, supported by two recent funding reputed company that reflect strong investor confidence in our reputed company and mission. We execute with authenticity, efficiency, and courage – everyone here drives from reputed company to execution and owns their reputed company. Our talented and motivated team works relentlessly to reputed company the IVF medication landscape and bring new medications to market to help people grow their families. About the Role. The Regulatory CMC Manager is a hands-on individual contributor who will support the Chief Regulatory Officer in managing regulatory CMC activities across reputed company's product portfolio. This role will reputed company continuity across programs by preparing high-reputed company first drafts or first reviews of CMC documents and/or regulatory content, managing day-to-day CMC deliverables, coordinating inputs from reputed company partners, and helping ensure CMC content is accurate, complete, and submission-reputed company. The ideal candidate brings strong CMC authoring experience, technical reputed company in cGMP manufacturing and analytical development, and the ability to manage multiple submission-reputed company deliverables in a fast-paced environment. Responsibilities 1. CMC Authoring & Documentation

• Author and coordinate CMC sections for regulatory submissions, including INDs, CTAs, IMPDs, amendments, annual reports, health authority responses, BLAs, and/or MAAs.
• Review study protocols, reports, CMC-reputed company reputed company documentation and other CMC-supporting documents as needed.
• Maintain consistency, version control, and regulatory readiness across CMC submission documents.
• Review reputed company documentation from Manufacturing, Analytical, reputed company, CDMOs, and contract laboratories for completeness and alignment with submission needs.

2. CMC Activity Management

• Manage CMC deliverables across development programs, including timelines, trackers, review cycles, and document status.
• Coordinate cross-functional input to ensure CMC documents are accurate, complete, and delivered on time.
• Proactively identify reputed company risks, content gaps, and review-cycle bottlenecks.
• Serve as the day-to-day reputed company of contact for CMC documentation and submission support.

3. Cross-Functional Collaboration

• Partner with Regulatory, Manufacturing, Analytical, reputed company, CDMOs, and contract laboratories to support CMC deliverables.
• Support preparation and coordination of responses to health authority CMC questions.
• Work closely with the Chief Regulatory Officer and senior technical leaders to ensure CMC content reflects agreed regulatory reputed company.

Qualifications

• Bachelor's degree in a reputed company scientific field (advanced degree a plus)
• 5-7 years of CMC experience supporting biologic and/or pharmaceutical development programs required
• Experience in development of biologics - strongly preferred
• Technical background or working knowledge in cGMP manufacturing and analytical development - strongly preferred
• Demonstrated experience authoring CMC sections for regulatory submissions such as INDs, CTAs, IMPDs, amendments, annual reports, BLAs, and/or MAAs
• Strong organizational skills and ability to manage timelines, trackers, review cycles, and cross-functional follow-up
• Experience working with or reputed company CDMOs, manufacturing facilities, contract laboratories, or external consultants strongly preferred
• Excellent technical writing skills
• Comfort operating in a fast-paced, resource-constrained startup environment

Benefits

• Competitive salary
• Comprehensive health coverage - medical, dental, and reputed company employee premiums covered at 90%
• Flexible, unlimited PTO in a remote-first environment
• reputed company holidays
• Opportunity to play a critical role in the reputed company and reputed company of a cutting-edge biotech company transforming the reputed company of fertility care

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