Senior Manager, Regulatory Affairs Specialist

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...

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 DescriptionInnova Solutions is seeking a highly skilled Regulatory Affairs Assistant - II to join our team. As a key member of our Regulatory Affairs team, you will be responsible for performing data entry using our Client RIM System to support key CMC RA stakeholders.Key Responsibilities:Perform data entry using Client RIM System to enter relevant...

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...

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...

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 Title: Senior Director Regulatory AffairsCorcept Therapeutics is a leading biopharmaceutical company dedicated to the research and development of cortisol modulators. We are seeking a highly experienced Senior Director Regulatory Affairs to join our team and support the commercialization of our late-stage programs.Key Responsibilities:Develop and...

Job DescriptionGilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need.We are seeking a highly skilled Director, CMC Regulatory Affairs to lead our Biologics portfolio. As a key member of our team, you will be responsible for defining regulatory...

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...

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...

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...

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...

Job Title: Associate Director, Regulatory AffairsBiomea Fusion, Inc. is seeking an experienced Associate Director, Regulatory Affairs to support the company's regulatory affairs strategies for IND/CTA/BLA/NDA filings and approvals.Key Responsibilities:Lead interactions and act as Subject Matter Expert on regulatory pharmaceutical and/or biotechnology...

We are seeking a highly skilled Public Affairs Project Manager to lead and oversee all aspects of public affairs project management for Acl Digital.The ideal candidate will have a strong background in project management and a passion for Public Affairs, Communications, and the Pharmaceutical industry.Key responsibilities include:Develop and implement project...

Job Title:Public Affairs Project ManagerJob Summary:We are seeking a highly skilled Public Affairs Project Manager to lead and oversee all aspects of public affairs project management for ACL Digital. The ideal candidate will have a strong background in project management and a passion for Public Affairs, Communications, and the Pharmaceutical industry.Key...

Transformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...

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 SummaryWe are seeking a highly skilled Medical Affairs Manager to join our team at ATR International. This role will be responsible for developing and executing global strategies for products in the LIFE franchise.Key Responsibilities:Collaborate with internal and external stakeholders to develop and execute global strategies for products in the LIFE...

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 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,...