Neogene Therapeutics
Manager Technical Writer, Regulatory Affairs - CMC
Neogene Therapeutics, Santa Monica, California, United States, 90403
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.
Position Summary
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 and 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.
Supervisory Responsibilities
Support hiring, leading and managing workflow.
Education and Experience
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.
The candidate must possess Chemistry, Manufacturing and Controls (CMC) and CTD experience.
The candidate must have CTD Module 3 authoring skills.
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 $101,000 to $139,000. 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.
Equal Opportunity Employer
#LI-Hybrid
DE&I Statement
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Position Summary
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 and 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.
Supervisory Responsibilities
Support hiring, leading and managing workflow.
Education and Experience
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.
The candidate must possess Chemistry, Manufacturing and Controls (CMC) and CTD experience.
The candidate must have CTD Module 3 authoring skills.
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 $101,000 to $139,000. 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.
Equal Opportunity Employer
#LI-Hybrid
DE&I Statement
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.