Regulatory Affairs Director

Associate Director / Director Regulatory AffairsHybrid - 3 days onsite6 month initial contract (likely exetnsion and convert to FTE)Responsibilities:Develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior concerning risks.Plan, prepare, and coordinate regulatory submissions, ensuring...

Job Title: Director Regulatory AffairsLocation: Weston, FL (near Miami and Fort Lauderdale, Florida (FL))Function: Regulatory AffairsReports to: Chief Regulatory Affairs Officer Job Summary:The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre-...

Invenia is working with a growing manufacturer of scientific instrumentation to hire a Director of Regulatory Affairs.The company manufactures cell biology tools to advance workflows in the cell & gene therapy and bioproduction markets. They have an has an excellent culture and truly value their employees.The role:The Director of Regulatory Affairs will be...

Director, Regulatory Affairs CMC Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...

Director, Regulatory Affairs CMC - Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...

Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...

Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...

Beacon Hill Staffing Group, LLC - Director of Regulatory Affairs - Strategy Summary of Position The Director of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. Responsibilities include defining and/or authoring compliant content for new and existing dossiers,...

The Talent Acquisition / HR team manages the recruiting for all positions at Adverum. We only accept resumes from search agencies or recruiters if the Talent Acquisition / HR team has formally requested your help and have a signed agreement in place. Unsolicited resumes sent to Adverum will be considered property of Adverum. The company will not be...

Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be...

Our premier client is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs. Reporting to the Chief Medical Officer, this position will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives. This position offers the opportunity for you to further develop a career in the...

Director of Pharmacovigilance & Regulatory Affairs About the Company Our client is a market leader in diagnostic imaging agents, a global company with under 1000 employees, with HQ in Boston. The person hired will direct all global pharmacovigilance activities and safety reporting for all marketed products, and oversee internal work team activities, and...

Associate Director / Director Regulatory AffairsHybrid - 3 days onsite6 month initial contract (likely exetnsion and convert to FTE)Responsibilities:Develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior concerning risks.Plan, prepare, and coordinate regulatory submissions, ensuring...

Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs, you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications;...

Sumitomo Pharma Director, Regulatory Affairs Saint Paul, Minnesota Apply Now Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology,...

Job Title: Regulatory Affairs Director for Pharmaceutical Product DevelopmentAbout Stirling Q&R:We are a leading pharmaceutical company in the San Francisco Bay Area, committed to developing and commercializing innovative therapeutic products. Our dynamic environment offers excellent opportunities for growth and professional development.Job Description:This...

The opportunity Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. You should bring both a track record of successful regulatory submissions that demonstrates...

Director/Sr. Director, Regulatory Affairs Calcilytix San Francisco, CA/Hybrid Regulatory Affairs Calcilytix Therapeutics , an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of...

JOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned...

Title: Senior Director of Regulatory Affairs Ad/Promo Summary: A global biopharmaceutical company, dedicated to pursing novel therapeutics to aid those with chronic illnesses is looking to grow their Regulatory Affairs team and bring on a Senior Director of Regulatory Affairs Ad/Promo to join their team! The team is growing rapidly as they have had great...