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Corcept Therapeutics
Menlo Park, CA, United States
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercor
Job Source: Corcept TherapeuticsRevolution 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 MedicinesCorcept Therapeutics
Menlo Park, CA, United States
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hyperc
Job Source: Corcept TherapeuticsAlector
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: AlectorCytokinetics
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: Alector4D 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 abi
Job Source: 4D Molecular TherapeuticsMazetx
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 persp
Job Source: MazetxSouth San Francisco, CA, United States
Reporting to the Senior Director of Regulatory Affairs, the Senior Manager, Regulatory Affairs is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects.
Responsibilities
Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence
Collaborate with cross-functional project teams and external business partners to develop regulatory strategies, identify regulatory risks and provide regulatory advice
Serve as primary regulatory representative for clinical studies and/or as the regulatory program lead
Manage coordination, preparation, and timely submission of regulatory documents and filings
Review global regulatory submissions for consistency and quality across regions, ensuring conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments)
Coordinate preparation of responses to queries from regulatory authorities
Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
Participate in regulatory due diligence activities
Relationships
Build and maintain collaborative relationships with external business partners and vendors to achieve project regulatory goals
Develop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
Coordinate activities for meetings and conferences with FDA, EMA, and other regulatory authorities
Management
May supervise employees, consultants/contractors and interns in Regulatory Affairs
Develop and implement regulatory operating guidelines and standard operating procedures
Qualifications
Bachelor’s degree, preferably in a scientific discipline, with 8+ years of drug development and 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry
Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions
Solid working knowledge of core processes: discovery, development, and manufacturing of small molecules
Experience with eCTD requirements and electronic submissions
Experience with international regulatory submissions and processes is a strong plus
Ability to work effectively across teams, functions and with outside partners
Excellent oral and written communication skills
Excellent organizational skills and attention to detail
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Email Alert for Associate Director, Regulatory Affairs jobs in South San Francisco, CA, United States
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