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BeiGene
San Mateo, CA, United States
**General** **Description:** BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet t
Job Source: BeiGenePliant 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 TherapeuticsThe 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 GroupALX 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 PharmaceuticalALX 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 PharmaceuticalEmeryville, CA, United States
General Description:
BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the aggressive timelines for the assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics.
Essential Functions of the job:
· Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-approval applications.
· Develop regulatory strategy and execute in the preparation of timely responses to small molecule CMC regulatory questions, pre-meeting packages, and interactions with Heath Authorities as needed for the assigned project
· Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects.
· Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior management timely.
· Lead or contribute to development of internal small molecule CMC regulatory guidance and working instructions.
· Ensures proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project.
· Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project.
· Provide comments on new global guidance through company’s commenting process.
Computer Skills: Microsoft 360
Qualifications:
Bachelor's Degree with 7+ years, Master's Degree with 5+ years, or PharmD/MD/PhD with 3+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience.
Small molecule experience required.
A proven record of leading Health Authority interactions, CTA, NDA/MAA, post-approval preparation, submission, and subsequent response to HA queries.
In-depth knowledge of ICH requirements and US/EU regulatory requirements. Knowledge/experience with regulatory requirements for rest of world regions and GMP regulation is a plus.
Demonstrated leadership as a people manager.
Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management.
Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc.).
Excellent oral and written communications skills are a must-have.
The candidate should be detail-oriented, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
Familiarity with Veeva system is a plus.
Travel: As needed.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Email Alert for Senior Manager, Regulatory Affairs, CMC jobs in Emeryville, CA, United States
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