VP Regulatory Affairs Oncology NDA Strategy

A leading global pharmaceutical company is seeking a Vice President for Regulatory Affairs in Oncology. The candidate will be responsible for overseeing all regulatory strategies, leading IND and NDA submissions, and ensuring compliance across all programs. The role demands extensive experience in Oncology regulatory affairs and strong leadership skills....

A global pharmaceutical company is seeking an Associate Director, Regulatory Affairs (Oncology) to lead regulatory activities for oncology products. The role involves managing US and global submissions, developing regulatory strategy, and mentoring team members. Ideal candidates possess strong communication skills, with at least 7 years in the...

Associate Director Regulatory AffairsSumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early-...

A leading management advisory firm is seeking a VP of Market Access Consulting to develop solutions in value and access strategies. The role requires extensive experience in market access within the biopharma space and strategic consulting. Candidates should also have strong skills in payer account management and trade distribution. This position offers a...

Position Summary Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of...

A leading public accounting and consulting firm is seeking an Assistant General Counsel for Litigation and Regulatory Affairs in Hartford, Connecticut. This role involves managing litigation responses, providing legal counsel on risks, and supporting overall legal strategy. The ideal candidate must have a Juris Doctor and at least 10 years of relevant...

As a senior leader within Medical Affairs, the Executive Director will serve as a strategic thought partner and Chief of Staff to the Vice President of Medical Affairs, providing high-level guidance and operational leadership across the organization. Leveraging a deep understanding of industry trends and internal priorities, this individual will shape the...

A leading pharmaceutical company is seeking a US Director of Medical Affairs for Gynecologic Malignancies, responsible for developing strategies and executing plans in oncology. The ideal candidate will have an advanced degree and a minimum of five years experience in medical affairs within the pharmaceutical industry. Strong leadership and communication...

Global Regulatory Affairs Leader This individual will have accountability for the global regulatory department and will lead a team of highly qualified regulatory professionals in oversight and management of key regulatory functions including global regulatory operations, strategy, labeling, and medical writing. Essential Duties and Responsibilities...

Senior Manager, Compliance and Regulatory Affairs Hartford, CT, Chicago, IL, Exton, PA, Philadelphia, PA or NYC As a Senior Manager, you will be a senior member of the Americas Compliance and Regulatory Affairs team and will play an integral role in AXA XL’s US Insurance Compliance and Regulatory operations within the Americas.This team is part of AXA...