Regulatory Affairs Director for Small Molecule Development

Regulatory Affairs DirectorRetro is seeking a highly skilled Regulatory Affairs Director to lead our regulatory efforts and help get our therapeutics from pre-IND to first-in-human clinical trial. As a key member of our team, you will oversee and advance the lifecycle of all of Retro's therapeutics, acting as the bridge between our internal research and...

Job Title: Director, Small Molecule Analytical Development, Analytical Development and OperationsAt BioSpace, Inc., we are seeking a highly experienced and skilled Director to lead our Small Molecule Analytical Development team. As a key member of our Analytical Development and Operations department, you will be responsible for shaping the development...

Job SummaryGilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas...

Transformative Opportunity in Regulatory AffairsNuvig Therapeutics is seeking a highly experienced Director, Regulatory Affairs to join our dynamic team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing global regulatory strategies to support our investigational studies. This is an exciting...

Job OverviewWe are seeking a highly skilled Regulatory Affairs Manager III to join our team at ATR International. This role will be responsible for leading the preparation of quality sections of regulatory submissions, including INDs/IMPDs, new marketing authorization applications, and post-approval variations.Key Responsibilities:Prepare high-quality...

Arcellx, Inc. is a pioneering biotechnology company dedicated to revolutionizing cell therapy for patients with cancer and other incurable diseases.We are committed to advancing humanity by developing cell therapies that are safer, more effective, and more accessible.As our Senior Director, Clinical Regulatory Affairs, you will play a critical role in...

Revolution Medicines: A Leader in Precision OncologyWe are seeking a highly skilled Senior Manager of Regulatory Affairs to join our team at Revolution Medicines, a clinical-stage precision oncology company dedicated to developing novel targeted therapies for RAS-addicted cancers.The OpportunityAs a key member of our Regulatory Affairs team, you will provide...

Job SummaryCorcept Therapeutics is seeking a highly experienced Senior Director, Regulatory Affairs - Advertising, Promotion, and Labeling to support the commercialization of our late-stage programs. This role will involve operational and strategic responsibilities, including delineating regulatory strategies for commercial and corporate communications,...

At Revolution Medicines, we are committed to developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a Senior Associate, Regulatory Affairs, you will play a crucial role in supporting our team in day-to-day operational aspects of the department and interacting with global regulatory authorities.The Opportunity: This...

At Corcept Therapeutics, we are dedicated to advancing the possibilities of cortisol modulation as a way to treat serious diseases.This role is responsible for partnering with Regulatory Affairs leaders to obtain and maintain regulatory filings and registrations for domestic and international regions.The Sr. Manager will coordinate activities with internal...

At Revolution Medicines, we are committed to developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.The Senior Manager of Regulatory Affairs will play a crucial role in providing project teams with regulatory advice, managing and coordinating various Regulatory Affairs activities within and between departments, and obtaining...

About the RoleNuvig Therapeutics Inc. seeks a highly skilled Director, Regulatory Affairs to join our team. In this role, you will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical, and CMC disciplines in support of investigational studies.Key ResponsibilitiesLead program teams in preparing...

Key ResponsibilitiesThe Regulatory Affairs Director will play a critical role in supporting Shell Energy's wholesale/retail trading/origination businesses and Shell Renewable and Energy Solutions related businesses through external advocacy for competitive markets, communicating regulatory changes and impacts of regulatory changes to commercial teams,...

Job Title: Senior Manager, CMC Regulatory Affairs, BiologicsAs a key member of the Mindlance team, you will be responsible for preparing high-quality regulatory submissions for biologics products. This includes preparing the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency...

Job Description:As a Regulatory Affairs Assistant - II, you will be responsible for performing data entry using the Client RIM System to support key CMC RA stakeholders. You will work collaboratively with the team to execute routine data entry, such as inputting submission-related dates and regulatory assessment comments. Your tasks will include ensuring the...

Medical Strategy and Development in OncologyCorcept Therapeutics is a leading company in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). Our team has discovered more than 1,000 selective proprietary cortisol modulators, and we have received FDA approval of Korlym...

Job Title: CMC Regulatory Affairs Data Entry SpecialistJob Summary: We are seeking a highly detail-oriented and organized Regulatory Affairs Data Entry Specialist to join our team at LanceSoft. The successful candidate will be responsible for performing data entry using Gilead RIM System to enter relevant information to support key CMC RA stakeholders. The...

Job SummaryWe are seeking a highly skilled Senior Scientist II to lead our Analytical Development team in the development of novel targeted therapies for RAS-addicted cancers. As a key member of our team, you will be responsible for analytical method development, validation, and transfer, as well as managing release testing, reference standard qualification,...

Job Title: Medical Affairs ManagerJoin LanceSoft, Inc. as a Medical Affairs Manager and contribute to the development and execution of global strategies for products in the LIFE franchise.Key Responsibilities:Collaborate with internal and external stakeholders to develop and execute global strategic activities.Develop and present presentation materials for...

Revolution Medicines, Inc.We are seeking a highly skilled and experienced Medical Director to join our team at Revolution Medicines, Inc. As a key member of our Medical Affairs leadership team, you will play a critical role in executing our global medical strategy across our portfolio.Key Responsibilities:Develop and implement global medical strategies to...