Vice President of Regulatory Affairs

About the Company

Leading biopharmaceutical firm specializing in oncology therapeutics

Industry
Biotechnology

Type
Public Company

Founded
2014

Employees
11-50

Funding
$101-$200 million

Categories

• Biopharma
• Biotechnology
• Therapeutics
• Healthcare
• Pharmaceuticals

Specialties

• Drug Discovery and Development
• Biologics
• Oncology
• and Immuno-Oncology

About the Role

The Company is a pioneering biopharmaceutical firm dedicated to developing innovative antibody-based therapeutics for a variety of human diseases, with a particular focus on oncology. The successful candidate for the VP of Regulatory Affairs role will be a key leader in shaping the company's future, driving the regulatory function, and providing strategic insights for successful product approvals. This executive will be responsible for leading the regulatory team, building regulatory strategy, and ensuring operational support across all clinical programs while maintaining compliance with US and international regulatory standards. The role involves delivering successful submissions and outcomes with health authorities, developing timelines and budgets for each clinical program, and coordinating with internal and external stakeholders to drive regulatory strategy.Applicants must have an advanced degree in a life/health sciences or healthcare-related field with significant industry experience, or a PhD/MD with a proven track record in an executive role within the life sciences sector. Experience in leading major regulatory submissions, particularly in oncology, and a deep understanding of the US regulatory framework are essential. The ideal candidate will be adept at cross-functional liaison, preparing executive-level presentations, and mentoring teams. They should be solution-oriented, with strong interpersonal and organizational skills, and the ability to manage multiple project objectives within set timelines. A comprehensive knowledge of the oncology drug development and regulatory landscape is required, as is the ability to work effectively in a diverse, collaborative team.

Hiring Manager Title
CEO

Travel Percent
Less than 10%

Functions

• Business Development