Senior Manager/Associate Director, Regulatory Operations
Location
South San Francisco, CA | United States
Job description
ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit
We are expanding our Regulatory Affairs team to include a Regulatory Operations function that will support development and commercialization activities of our therapeutic candidates. We are looking for a Senior Manager/Associate Director, Regulatory Operations to join our team. The successful candidate will be required to reside within a commutable distance of our South San Francisco office. ALX Oncology Inc. follows a hybrid work model (i.e., part-time in South San Francisco office with flexibility to work part-time remotely).
The
Senior Manager/Associate Director, Regulatory Operations will report to VP, Regulatory Affairs and Quality. In this hands-on role, the successful candidate will work with a diverse team of professionals providing regulatory operations support to various regulatory filings and projects. This position will also support and provide key contributions to the Regulatory Affairs department and company-wide initiatives.
The successful candidate for this role will have demonstrated experience and a clear understanding of electronic Common Technical Document (CTD) content and format requirements and will be experienced in the creation of high-quality pharmaceutical regulatory submission packages. They will have overall responsibility for planning, formatting, publishing, QC and dispatch of FDA regulatory submissions according to project timelines, as well as, submission archival and tracking of global regulatory submissions and health authority correspondence. They will address technical editing (i.e., references, internal linking, definitions, acronyms, etc.) and document formatting for submission readiness and will provide final approved documents and submission preparation guidance to our publishing vendor. They will also be responsible for vendor oversight and management of publishing activities to ensure compliance with electronic submission standards. They will have responsibility for systems related to submission management and preparation, including oversight and planning for new system implementation.
Responsibilities: - Collaborating with regulatory and cross-functional team members and external contractors/vendors/consultants to support the planning, preparation, formatting, publishing, QC, submission and archival of US and international regulatory applications (i.e., investigational new drug applications [INDs] and amendments, clinical trial applications [CTAs] and amendments, responses to health authority requests for information, biologic license applications [BLAs], etc).
- Collaborating with our external publishing vendor on e-submission publishing activities to assure on time regulatory submissions in accordance with project goals and timelines.
- Maintaining regulatory submission and correspondence archive, including updating submission trackers.
- Managing the projected regulatory submissions spreadsheet and assuring alignment of resources and timelines with the external publishing vendor.
- Maintaining templates and style guides for regulatory submissions and providing internal regulatory document preparation technical support.*
- Contributing to process improvements, which have a positive impact on the working of the Regulatory Affairs function and other departments such as participating in the development of standard operating procedures and work instructions.
- Lead the implementation, set-up and ongoing maintenance of a regulatory information management system (RIMS), liaising with cross-functional partners as required.
Requirements: - BA/BS degree in a scientific discipline.
- 6-8+ years' experience in the pharmaceutical industry or life sciences with a minimum of 5 years of regulatory operations experience.
- Track record of successful IND/CTA/BLA/MAA e-submissions to regulatory agencies and the ability to contribute to the submission of global regulatory applications, as needed.
- Thorough understanding of ICH/US/EMA regulations and guidelines related to electronic records and signatures and eCTD standards.
- Experience with implementing / maintaining / utilizing Veeva Vault RIMS, is preferable.
- Knowledge of Microsoft Office including Teams, Adobe Acrobat, electronic document management systems, Egnyte, Toolbox, submission authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools.
- Ability to interact with team members using a collaborative working style.
- Ability to multi-task and prioritize in a fast-paced environment.
- Ability to work independently with minimal supervision or direction.
- Strong organizational and time-management skills.
- Attention to detail with accuracy and quality and ability to problem-solve.
- Excellent oral, written communication and interpersonal skills.
- Highly responsible, self-motivated professional.
- Prior regulatory operations experience in oncology is preferred.
Salary: $160,000-$190,000
ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.
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