Executive Director, Regulatory Affairs
Confidential
Executive Director, Regulatory Affairs
About the Company
Innovative biotechnology (BioTech) company specializing in precision therapies for autoimmune & inflammatory diseases
Industry
Biotechnology
Type
Privately Held
Founded
2025
Employees
51-200
Specialties
- biotechnology
- pharmaceuticals
- drug development
- clinical development
- inflammatory diseases
- autoimmune diseases
- immune-mediated diseases
- immunology
- and precision therapies
About the Role
The Company is seeking an Executive Director for Regulatory Affairs to lead the global regulatory strategy and execution for its innovative therapeutic candidates. The successful candidate will be a seasoned professional with a minimum of 15 years' experience in regulatory affairs, including at least 5 years as a Global Regulatory Lead. The role involves direct and coordinated regulatory strategy for a range of submissions, from INDs to marketing applications, and requires a deep understanding of global regulatory requirements, particularly in the US and Europe. The Executive Director will be responsible for maintaining compliance, managing regulatory timelines, and overseeing a team to ensure the accuracy and completeness of all regulatory documents. Experience in immunology is highly preferred, and the ideal candidate will have a proven track record of leading global marketing applications and post-marketing activities. Applicants for the Executive Director position at the company should hold an advanced degree in a relevant life sciences discipline and have a strong background in regulatory affairs within the pharmaceutical or biotechnology industry. The role demands a proactive, execution-oriented individual with excellent leadership, communication, and interpersonal skills. The candidate must be adept at managing and mentoring a team, as well as being able to work independently and collaboratively to drive the regulatory process. A successful candidate will be able to balance strategic oversight with hands-on execution, demonstrate an entrepreneurial mindset, and have a history of effective negotiations with global health authorities. The position is pivotal in the company's mission to develop and deliver precision therapies that have the potential to transform the lives of patients with autoimmune and inflammatory diseases.
Hiring Manager Title
Senior Vice President, Regulatory Affairs & Quality
Functions
- Legal
- Operations
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