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BioSpace · 2 days ago
Senior Director, CMC Regulatory Affairs Biologics Project Lead
Foster City, CA
Full-time
Onsite
Senior Level, Director
$238K/yr - $308K/yr
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Responsibilities
Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions.
Implement global CMC regulatory strategies to enable life-cycle product/process development strategy while maintaining global licensure and right to operate of Gilead's operations.
Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
Guide the development of regulatory strategies and solutions for complex CMC challenges for Clinical through Growth (newly approved) products submission, commercial registration, including risk mitigation.
Exercise expertise in the interpretation and implementation of ICH guidelines with a goal of an approved/ harmonized regulatory control strategy.
Ensure regulatory conformance & consistency for assigned products globally in compliance with regulatory requirements and internal procedures.
Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead.
Promote the use of novel approaches within project teams to resolve issues and problems.
Develop meaningful and collaborative relationships with cross-functional teams and leaders.
Lead CMC strategies, assess risks, and develop contingency plans, including major, complex applications.
Demonstrate and model Gilead's Core Values, Leadership Commitments, and People Leader Accountabilities; Embrace and comply with global CMC principles of integrity.
Demonstrate success in influencing without positional authority within a highly matrixed organization.
Qualification
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Required
A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.
Demonstrated track record in defining innovative CMC regulatory strategies, and implementing at a platform level.
Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions.
Application of sound and accurate judgment to make timely decisions.
Demonstrated organizational leadership skills at a functional level.
Excellent strategic acumen, collaboration, and communication skills are required.
Demonstrated commitment to inclusion, developing talent and empowering teams.
Benefits
Company-sponsored medical
Dental
Vision
Life insurance plans
Company
BioSpace
BioSpace is the leading online community for industry news and careers for life science professionals.
Founded in 1988
11-50 employees
H1B Sponsorship
BioSpace has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$10M2000-08-24Series B· $10M
Leadership Team
J
Joshua Goodwin
CEO and President
K
Kristin Jones
Chief Revenue Officer
Recent News
2024-05-31
2024-05-05
2024-04-06
Company data provided by crunchbase
