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Maze Therapeutics
South San Francisco, CA, United States
The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you
Job Source: Maze TherapeuticsBioSpace
South San Francisco, CA, United States
The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you
Job Source: BioSpaceMazetx
South San Francisco, CA, United States
Become a genetic navigator. Our mission is to discover new genetic insights and translate them into new precision medicines. With an unparalleled commitment to changing the way people with severe diseases are treated, our team is at the forefront of accelerating our understanding of the genetic drivers of disease. We celebrate a diversity of pers
Job Source: MazetxExelixis
Alameda, CA, United States
SUMMARY/JOB PURPOSE: Responsible for primary regulatory review of promotional materials and scientific exchange communications. This role demonstrates proficiency in understanding and interpreting Federal regulations and guidances and company standard operating procedures (SOPs) to support the advertising and promotions of Exelixis' FDA (Food and
Job Source: ExelixisCytokinetics
South San Francisco, CA, United States
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mecha
Job Source: CytokineticsAlector
South San Francisco, CA, United States
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare in
Job Source: AlectorConfidential
San Francisco, CA, United States
Executive Director, Regulatory Affairs About the Company Pioneering developer & manufacturer of innovative therapeutic medicines Industry Biotechnology Type Public Company Founded 1980 Employees 10,001+ Categories Biotechnology Biotechnology and Pharmaceuticals Biotech Health Care Pharmaceutical Pharmaceuticals Academic Research Manufacturing Geno
Job Source: Confidential4D Molecular Therapeutics
Emeryville, CA, United States
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your a
Job Source: 4D Molecular TherapeuticsSan Francisco, CA, United States
Company Location: Bay Area
Comp: 150K-220K
Position Reports to: VP of Regulatory and Quality
Director of Regulatory Affairs -San Francisco
We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop & execute regulatory strategy. The person in this role manages a team over RA and QMS.
Responsibilities
This person will represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, review and approve protocols, reports, and other product development and manufacturing documentation to ensure compliance with regulatory requirements.
Manage the EUMDR transition to ensure continued business with existing products and timely new product CE marking.
Work closely with research and development, clinical, quality and marketing teams to ensure regulatory considerations are integrated into product development and launch plans.
Develop and plan strategies and contingency plans for projects related to NPD.
Provide direction and guidance to project teams to execute complex regulatory affairs projects & initiatives.
Will include preparation of documentation packages for submission to regulatory agencies globally.
Interact with regulatory agencies as part of submission review and on-site audit support.
Oversee team members in RA and QMS, to execute business plans and strategies for RA success.
Qualifications Education/Experience Requirements
Bachelor’s degree required with a concentration in life sciences, technical, engineering or related field
Advanced degree strong preferred
10+ years of experience in Regulatory Affairs submissions in a Senior/Principal/Program leadership function.
3+ years in a management capacity
3+ years of experience in medical device, drugs, biologics, and/or combination products, preferred
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Email Alert for Regulatory Affairs Director jobs in San Francisco, CA, United States
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