Head of Regulatory Affairs Oncology - Military veterans preferred

Head of Regulatory Affairs Oncology

About the Company Expanding oncology company Industry Hospital & Health Care Type Public Company

About the Role The Company is seeking a Head of Regulatory Affairs with a focus on Oncology. This pivotal role involves providing strategic regulatory expertise and leadership to ensure the company's objectives are met. The successful candidate will be responsible for global regulatory activities, including the planning, management, and execution of regulatory strategies. Building and maintaining strong relationships with internal and external stakeholders, including global health authorities, is a key aspect of the position. The Head of Regulatory Affairs will also be involved in the preparation and coordination of regulatory submissions, such as INDs, NDAs, and equivalent international filings, and will serve as the primary liaison to key market Health Authorities.Applicants must have a Bachelor’s degree in a scientific discipline, with an advanced degree being a plus, and a minimum of 10 years of experience in a pharmaceutical or biotechnology organization, including a significant tenure in a Regulatory Affairs leadership role. Oncology experience is a mandatory requirement, and experience in regulatory CMC and CDx is preferred. The ideal candidate will have a deep understanding of US and EU regulatory guidelines and a proven track record of success in gaining regulatory approvals through effective relationship building with global health authorities. Experience with INDs, NDAs, CTAs, and post-marketing/life cycle management is also essential. The role is open to remote candidates on the East Coast, with the expectation of travel to New Jersey 1-3 times per month. Travel Percent Less than 10% Functions Medical Care/Hospital Administration

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