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Bayside Solutions
Santa Clara, CA, United States
Director, CMC Regulatory Affairs Direct Hire Full-Time Role Salary Range: $208,000 - $235,000 per year Location: Redwood City, CA - Hybrid Role Job Summary: The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual mark
Job Source: Bayside SolutionsAdverum 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.Adverum 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.Meet Recruitment
San Jose, CA, United States
My client is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare diseases. They are currently seeking a skilled regulatory professional to join their growing team as Director/ Sr. Director CMC Regulatory Affairs. This role will involve hands-on development and implementation of regulatory strategies for CM
Job Source: Meet RecruitmentREVOLUTION Medicines
Redwood City, CA, United States
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment
Job Source: REVOLUTION MedicinesMeet
Redwood City, CA, United States
Senior Director, Regulatory Affairs (Generalist) Hybrid Role - 3 Days in Menlo Park, CA Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Reg
Job Source: MeetMeet Recruitment Limited
Redwood City, CA, United States
Senior Director, Regulatory Affairs (Generalist) Hybrid Role - 3 Days in Menlo Park, CA Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Reg
Job Source: Meet Recruitment LimitedSanta Clara, CA, United States
Director, CMC Regulatory Affairs
Direct Hire Full-Time Role
Salary Range: $208,000 - $235,000 per year
Location: Redwood City, CA - Hybrid Role
Job Summary:
The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of pipeline compounds/products.
Duties and Responsibilities:
Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products.
Lead the preparation and maintenance of the CMC/quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.
Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met.
Work with the corporate regulatory team, CMC SMEs, and CROs to identify regional/country-specific CMC requirements to support global applications and to drive the CMC submission timelines to meet business objectives.
Participate in the interactions with FDA and other global regulatory authorities as appropriate.
Provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product life cycle.
Participate in the regulatory process initiatives and improvement activities.
Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders.
Requirements and Qualifications:
An advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field is preferred.
15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules
Experience leading CMC-related global submissions (IND, IMPD/CTA, NDA, MAA, etc.)
Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues
Demonstrated experience in effective collaboration with internal and external stakeholders
Able to prioritize and manage multiple projects simultaneously in a dynamic company environment
Effective written and verbal communication skills and good interpersonal skills
Desired Skills and Experience
CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development
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Email Alert for Director, CMC Regulatory Affairs jobs in Santa Clara, CA, United States
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