Manager Technical Writer, Regulatory Affairs - CMC

$101,000 - $139,000/Yr

Neogene Therapeutics - Santa Monica, CA

Full-time - Mid Level

Hybrid - Santa Monica, CA

About the position

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. The Manager CMC Regulatory Affairs is responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical, and Regulatory Affairs to ensure all Regulatory CMC technical writing objectives are met for the innovative pipeline of early and late-stage T cell therapies. This position is hybrid and can have managerial responsibilities in the future. The role reports to the Associate Director, CMC Regulatory Affairs.

Responsibilities

• Author the CMC sections of regulatory documents (e.g., IND/IMPD, BLA/MAA, health authority questions, briefing documents) to support the timely submissions of investigational and marketing applications.
• 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.
• Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations.
• Support the development and maintenance of regulatory templates, best practices, and procedures.
• Perform other responsibilities as needed.

Requirements

• BA/BS degree in life sciences required, advanced degree preferred (MS, PharmD).
• Experience of 8+ years with BS/BA; 6+ years with MS/MA.
• Prior experience in cell/gene therapy.
• Possess Chemistry, Manufacturing and Controls (CMC) and CTD experience.
• CTD Module 3 authoring skills are required.
• Experience in IND, IMPD, BLA, MAA filings.

Benefits

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