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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.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.Ultragenyx Pharmaceutical
Brisbane, CA, United States
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies w
Job Source: Ultragenyx PharmaceuticalAdverum 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.Adverum 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 BiotechnologiesPliant 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.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 investigational products for US, Asia and LATAM and marketed products for US in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Responsible for routine clinical and commercial labeling approvals and changes, protocol reviews, drug listing review and ensure ensuring product packaging and associated information is updated and maintained in accordance with the product license.
Develop and maintain knowledge of regulatory requirements independently and with line manager.
Assess change controls for regional regulatory impact and record assessment using a variety of internal systems.
Contribute to local process improvements, which have an impact on the working of the RA CMC function or other departments.
Primarily plans, schedules and arranges own activities in alignment with project goals and deadlines.
Must be capable of leading a small team in preparation of regional submissions.
Education & Experience
Required Bachelor's Degree with a minimum of 6+ years of relevant training or industry experience preferably in a GMP environment, OR a Master's Degree with a minimum of 4+ years of relevant training or industry experience preferably in a GMP environment.
Preferred Degree in a relevant scientific field.
Relevant Regulatory CMC submission experience.
Regulatory Affairs Certification (RAC).
Pay Range: $50 - $70/Hour
Duration: 12+ months
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Email Alert for Regulatory Affairs CMC Associate jobs in San Mateo, CA, United States
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