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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 MedicinesAscendis Pharma
Palo Alto, CA, United States
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core
Job Source: Ascendis PharmaCytokinetics
South 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 reg
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: AlectorAbbott
Santa Clara, CA, United States
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Job Source: AbbottCytokinetics
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: CytokineticsAbbott Laboratories company
Santa Clara, CA, United States
Working at Abbott. At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youll also have access to:Career development with an international company where you can grow the care Regulatory Affairs, Director, Regulatory, Associate, Product Development, Healthcare, Business Servi
Job Source: Abbott Laboratories companyMenlo 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 hypercortisolism (Cushing's syndrome).
Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
This role's primary responsibility is to partner with Regulatory therapy area leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions. This Associate Director will coordinate activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants) to maintain up-to-date information on regulatory requirements and product submissions.
Responsibilities:
Provide team and department leadership
Manages most aspects of company regulatory interface with domestic and international health authorities
Manages the development and deployment of the regulatory program that ensures aggressive product approval
Manages and may generate regulatory submission documents for new products or changes to existing health authorities' filings, including domestic and international submissions and registration
Manages and/or oversees project-related nonclinical and clinical submissions
Maintain up-to-date knowledge of regulatory requirements. Disseminates information regarding governmental regulations and guidances that may affect company processes. Provide expertise in translating regulatory requirements into practicable, workable plans and follows up, as applicable, to assure awareness for company compliance
Partners with various teams throughout organization (Clinical Operations, R&D, Quality, etc.) on projects
Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations
Determines international regulatory requirements and develops plans to comply with national laws in each country
Provides guidance with localization and labeling requirements
Manages regulatory reporting requirements for investigational products
Provide support for meetings with FDA/health authorities
Help maintain regulatory files
Support the timely preparation of organized and scientifically valid applications to Health authorities
Contribute to the development and implementation of standard operating procedures (SOPs) and policies
Preferred Skills, Qualifications and Technical Proficiencies: Strong analytical and problem-solving skills.
Strong written and verbal communication skills, including the ability to interact effectively and to influence.
Strong attention to detail.
Customer focused and adaptable, with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations.
Preferred Education and Experience: Bachelors or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline.
Minimum of 5 years of relevant regulatory experience.
The pay range that the Company reasonably expects to pay for this headquarters-based position is $204,000-$240,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
Email Alert for Associate Director, Regulatory Affairs jobs in Menlo Park, CA, United States
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Please refresh the page and try again.
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