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ALX Oncology Inc.
South San Francisco, CA, United States
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 informa
Job Source: ALX Oncology Inc.The Fountain Group
San Mateo, CA, United States
Overview: Prefers the candidate to be local in the Bay Area BUT will consider qualified candidates with Pharma Regulatory CMC experience in the Pacific time zone ONLY. Responsibilities Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for invest
Job Source: The Fountain GroupAdverum Biotechnologies
Redwood City, CA, United States
The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. This individual will be the key interface between the Regulatory and CMC functions, partner with Process Development, Manufacturing, Supply Chain, and Quality; and assist in ensuring regulatory compliance. The Director/Sr will be r
Job Source: Adverum BiotechnologiesAdverum Biotechnologies, Inc.
Redwood City, CA, United States
The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum's gene therapy program/s. This individual will be the key interface between the Regulatory and CMC functions, partner with Process Development, Manufacturing, Supply Chain, and Quality; and assist in ensuring regulatory compliance. The Director/Sr will be r
Job Source: Adverum Biotechnologies, Inc.Pliant Therapeutics, Inc.
South San Francisco, CA, United States
Description Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs – CMC will be responsible for leading, developing, and executing CMC regulatory strategies on programs ranging from early to late-stage development, including preparation and filing of IND and NDA/MAA submission. This position will sit on cros
Job Source: Pliant Therapeutics, Inc.Pliant Therapeutics
South San Francisco, CA, United States
Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As
Job Source: Pliant TherapeuticsAdverum Biotechnologies, Inc.
Redwood City, CA, United States
The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. This individual will be the key interface between the Regulatory and CMC functions, partner with Process Development, Manufacturing, Supply Chain, and Quality; and assist in ensuring regulatory compliance. The Director/Sr will be r
Job Source: Adverum Biotechnologies, Inc.Cargo Therapeutics
San Carlos, CA, United States
Description Reporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio. The successful candidate will have a strong background in regulatory CMC with deep expertise in biologic product development. They must have comprehensive knowle
Job Source: Cargo TherapeuticsSouth San Francisco, CA, United States
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 www.alxoncology.com.
We are expanding our existing group of exceptionally talented and well-motivated colleagues to develop and commercialize our lead candidate, evorpacept.
We are looking for an Associate Director/Director, Regulatory Affairs CMC to join our team.
This position will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development programs for evorpacept and others. In this hands-on role, s/he will provide dynamic leadership and direction to multi-disciplined project teams and will work collaboratively with cross-functional team members to achieve development milestones in an efficient and compliant manner. This position will also support and provide key contributions to department and company initiatives related to regulatory affairs operations and strategy. 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).
Responsibilities:
These include but are not limited to:
Providing dynamic regulatory leadership to project teams and working collaboratively with cross-functional team members and external contractors/vendors/consultants to identify optimum and workable regulatory strategies for assigned projects.
Lead teams in examining regulatory strategy options, provide relevant regulatory guidance / precedents and stay abreast of the regulatory and competitive landscape.
Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones/goals as assigned, including regulatory strategy development.
Identify and assess regulatory risks and critical-path activities associated with CMC development programs and work to identify regulatory strategies to mitigate risks.
Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on development programs and stay abreast of the regulatory landscape. Assume a global view of CMC regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.
Evaluate proposed CMC changes for global impact and provide sound regulatory strategies that support compliant change implementation.
Lead global CMC regulatory submission development - responsible for planning, coordinating, and developing high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, BLA/MAA, pre-meeting briefing documents, etc.).
Prepare and lead teams through successful regulatory meetings and interactions.
Lead assigned department initiatives and seek opportunities to improve interdepartmental collaboration.
Build positive professional relationships and trust with teammates and regulatory authority contacts.
Supervise or indirectly supervise other regulatory personnel, as assigned.
Qualifications: Minimum bachelor's degree; studies in science, and advanced degree highly desirable
Minimum 8-10+ years progressive Regulatory Affairs experience; 6+ years with an advanced science-related degree.
Prior regulatory experience and understanding of therapeutic development in the field of oncology is desired.
Good understanding and knowledge of large molecule biologics manufacturing and analytical methods is desired.
Successful track record of interacting with regulatory health authorities and moving products through the development process.
Extensive knowledge of regulatory requirements and experience with US, EU RoW regulatory submissions (IND/CTA/BLA/NDA, etc.) in eCTD format.
Extensive experience working on development programs and driving regulatory strategies specifically relating to the CMC aspects of the project.
Ability to create and manage detailed timelines and track regulatory activities across disciplines and territories.
Prior experience in other key functional areas, (e.g., research, toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics), is desired.
Strong interpersonal skills, as well as oral and written communication skills.
Highly responsible, self-motivated professional.
Strong leadership skills that include a desire for accountability.
Highly collaborative working style with the ability to influence others.
Superior work ethic that includes working autonomously with an appropriate sense of urgency and accuracy.
Entrepreneurial orientation with the ability to effectively operate in a dynamic environment.
Excellent organizational skills that enable the successful execution of multiple simultaneous projects.
High energy, enthusiasm, and passion for the work.
Salary:
Associate Director: $169,000-$190,000
Director: $230,000 -$240,000
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.
Email Alert for Associate Director, Regulatory Affairs CMC jobs in South San Francisco, CA, United States
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