Director, CMC Regulatory Affairs

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...

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...

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 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 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...

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...

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...

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...

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...

About the ClientOur client is a pioneering company in the field of robotic systems for medical diagnosis and treatment, with a focus on advanced surgical interventions for complex conditions.Job SummaryWe are seeking a highly qualified Director of Regulatory Affairs to join our dynamic R&D team. This role is critical in driving the development of innovative...

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...

About the RoleWe are seeking a highly qualified Director of Regulatory Affairs to join our dynamic R&D team. This role is critical in driving the development of innovative imaging agents, ensuring their successful navigation through regulatory pathways.Key ResponsibilitiesLead NDA Preparation: Oversee all New Drug Application (NDA) preparation activities,...

Revolution Medicines: A Leader in Precision OncologyWe are seeking an experienced Associate Director 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...

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 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 support the commercialization of our late-stage programs.Key Responsibilities:Develop and implement regulatory...

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...

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...

About Arcellx, Inc.Arcellx, Inc. is a pioneering biotechnology company dedicated to revolutionizing cell therapy for patients with cancer and other incurable diseases. Our mission is to develop innovative immunotherapies that are safer, more effective, and more accessible.Job Title: Senior Director, Clinical Regulatory AffairsWe are seeking an exceptional...

About ArcellxArcellx is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.Job SummaryWe are seeking a Senior...

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...