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Arcus Biosciences
Hayward, CA, United States
Description The Senior Director of Regulatory Affairs provides regulatory leadership and develops regulatory strategies for products in development to support clinical trial application and marketing approvals in the US and internationally. Acts as a resource to the broader regulatory function, including mentorship of less experienced staff. Resp
Job Source: Arcus BiosciencesArcus Biosciences
Hayward, CA, United States
Description Senior Manager, Regulatory Affairs CMC Summary: The Senior Manager, Regulatory Affairs CMC will provide support on a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. The individual must have the ability to work independently and as an effective and engaged team member in a fast
Job Source: Arcus BiosciencesBD
Milpitas, CA, United States
Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of
Job Source: BDBayside Solutions
Fremont, 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 SolutionsZEISS
Dublin, CA, United States
Employer: Carl Zeiss Meditec, Inc. Position: Senior Regulatory Affairs Specialist Duties: Works collaboratively with Global Regulatory Affairs, Product Development Teams and Product Marketing to register products in the United States. Additionally, this person supports and as appropriate develops pre-launch regulatory strategies, and facilitates
Job Source: ZEISSStryker
Fremont
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (loudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits
Job Source: StrykerAlameda Health System
Concord, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemAlameda Health System
Dublin, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemHayward, CA, United States
The Senior Director of Regulatory Affairs provides regulatory leadership and develops regulatory strategies for products in development to support clinical trial application and marketing approvals in the US and internationally. Acts as a resource to the broader regulatory function, including mentorship of less experienced staff. Responsibilities Provides strong regulatory and scientific leadership to the overall development team to ensure that the development plan provides for optimal scientific positioning and highest regulatory probability of success
Interprets and applies regulations in the creation of timely and innovative regulatory strategies for US and international markets
Represents the regulatory function on cross-functional development teams
Plans, prepares, and reviews submissions to regulatory authorities including FDA, EMA and other global health authorities to support the conduct of clinical trials and approval of marketing applications (including but not limited to Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA)/Biologic Licensure Application (BLA), and Marketing Authorization Application (MAA).
Works with regulatory submissions coordinator to develop submission timelines and work with cross-functional teams to planned objectives
Serves as the primary point of contact with FDA and other health authorities as applicable
Interacts with regulatory agencies, coordinating the preparation and supporting documentation as well as leading meetings and other interactions; maintains correspondence and other records of interaction
Manages all maintenance plans for regulatory investigative and marketing applications for assigned projects
Manage and provide guidance/training for regulatory staff members, including regular feedback and coaching for professional development
Develop relationships with external partners
Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development programs
Provides regulatory guidance and/or training to external departments
Prepares and revises internal procedures for continuous improvement
Manages activities performed by regulatory
Education/Experience/Skills Bachelor’s degree in a life science required, PhD, PharmD or Master's degree preferred
A minimum of 10+ years in regulatory affairs with 15+ years in the biotech/pharma industry relevant to the respective regulatory function with a minimum of 5 years in a leadership role preferred.
Experience in oncology drug development a must.
Thorough knowledge of US and international regulations as they apply to pharmaceutical and biologic drug development
Previous experience managing development of INDs and other global clinical trial applications
Experience leading regulatory agency interactions, meetings
Ability to work in a cross-functional team environment and a flexible team-oriented perspective
Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills
Demonstrated problem solving abilities and conflict resolution skills
Proficiency in MS Office applications and internet researching
Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization
Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals
Other duties as assigned
This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $215,000 - $296,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers. EOE Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets #LI-EW1 #LI-Remote
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Email Alert for Senior Director, Regulatory Affairs (Office or Remote) jobs in Hayward, CA, United States
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