Associate Director / Director, CMC Regulatory Affairs
- Kezar Life Sciences
- South San Francisco, California
- Start date
- Feb 26, 2023
- Regulatory, Regulatory Affairs, Science/R&D, CMC
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Biotech Bay
Kezar Life Sciences is seeking an Associate Director or Director of Regulatory Affairs CMC. This position will report to the VP of Regulatory Affairs and will be responsible for providing the CMC and regulatory expertise necessary to lead the development, implementation, and influence of CMC regulatory strategy for New Chemical/Molecular Entity (NCE/NME), small‑molecule drugs, including global submission strategy for investigational applications, clinical trial support, marketing application strategy, and CMC change management. The expectation is to be onsite at our South San Francisco, CA office at least three days per week.
Kezar is focused on small-molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, zetomipzomib, is being evaluated in clinical trials for the treatment of lupus nephritis and autoimmune hepatitis. Kezar is also conducting an oncology clinical trial of KZR-261, the first candidate from its novel platform targeting the protein secretion pathway. This research platform has the potential to generate additional small molecule compounds with therapeutic potential in cancer and inflammation.
Key Responsibilities include:
- Oversee and direct all regulatory CMC strategies in compliance with global regulatory requirements for the development of our products.
- Provide CMC regulatory support for new and ongoing clinical trials (e.g., clinical trial applications and import licenses, provide input for clinical protocols, labels, and other study-related materials).
- Work collaboratively with Pharmaceutical Development, Drug Substance, and GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
- Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans.
- Planning, oversight, and management of all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs, etc.
- Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).
- Provide support for cGMP activities as they relate to regulatory affairs (e.g., regulatory impact assessments for change management, regulatory inspection support).
- Drive a culture of continuous improvement to ensure compliance with Kezar standards, procedures, regulatory requirements, and expectations.
- Lead responses to CMC-related queries from health authorities.
- Lead preparation for CMC-related meetings with regulatory agencies.
Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.
Preferred Qualifications Include:
- BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
- 10+ years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. Candidates at the Director level would be expected to have significant years of additional experience.
- Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally sterile parenteral and solid-oral dose formulations, manufacturing, and regulatory writing.
- Experience in addressing CMC-related regulatory queries from global health authorities.
- Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies.
- Experience with lyophilized products and injectable drug-device combination products, preferred.
- Demonstrated success driving drug product development and managing all aspects of CMC documentation.
- Excellent working knowledge and understanding of applicable global regulations required – cGMP, global regulatory guidances, compendial requirements, including FDA, EMA, ICH, WHO, USP-NF.
- Prior experience as primary author of CMC sections of M2 and M3 of IND and NDA, and IMPD.
- Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents (e.g., Veeva Vault, StartingPoint templates, etc.).
- Excellent attention to detail, and strong computer and organizational skills required.
- Must be a strong team player who is fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
- Must have a quality mindset and deliver results in an ethical and positive manner.
- Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
- Proven ability to manage multiple tasks and associated deadlines.
Compensation and Benefits
The salary range for this position as Associate Director at our South San Francisco, CA corporate office is $190,000 - $200,000. The salary range for candidates at the Director level is $210,000 - $225,000. Factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, Kezar Life Sciences offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information about our total rewards program can be found here: Join Our Team - Kezar Life Sciences Inc.
About Kezar Life Sciences
We are developing first-in-class, small molecule therapies designed to inhibit multiple disease-driving cellular pathways by targeting key intracellular proteins. Since inception, our mission has been to deliver unique treatments that can better the lives of patients fighting difficult-to-treat chronic diseases. Our team is passionate about discovering promising targets that were previously unidentified or undruggable and have the potential to change the treatment paradigm for a range of conditions.
Here at Kezar, our employees are our greatest asset and are the drivers of the Company’s success. Every day, our team of passionate professionals are converting scientific ideas to first-in-class assets that have the potential for significant clinical impact in the most difficult-to-treat diseases. Together, we are focused on the common mission of helping patients overcome their chronic conditions and live a better life.
We believe in fostering a culture of trust and respect for all team members at all levels. Our employees are encouraged to question, exchange views and discover new ways to address issues and solve problems. We welcome differences in ideas, styles and practices to accomplish our goals. Hard working, innovative and compassionate are qualities every Kezar employee should possess and we’re always looking for equally dynamic and motivated individuals to join our team.
Information for Recruitment Agencies
Kezar Life Sciences does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Kezar Life Sciences employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.
4000 Shoreline Ct
South San Francisco
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