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Director, US Regulatory Affairs
Life Sciences
Baskin Ridge, United States
250,000 USD
6 Mar 2025
Job Description
Director, Regulatory Affairs (US)
About the Company:
Our client is a leading global pharmaceutical company dedicated to advancing innovative therapies that address critical and underserved medical needs. With a long-standing history of scientific excellence and a presence across multiple continents, their passionate team is focused on developing transformative treatments in areas such as oncology, rare diseases, and immune disorders. Their mission is to improve patient outcomes through cutting-edge research and the delivery of impactful healthcare solutions.
About the Role:
This role will drive the development and execution of regulatory plans, ensuring alignment with organizational goals and effective collaboration with health authorities. The ideal candidate will have a strong background in US regulatory affairs, with expertise in guiding submissions from IND through NDA/BLA. This position also involves mentoring team members and fostering innovative approaches to regulatory challenges.
Key Responsibilities:
Qualifications:
Equal Opportunity Employer:
We are committed to creating a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
About the Company:
Our client is a leading global pharmaceutical company dedicated to advancing innovative therapies that address critical and underserved medical needs. With a long-standing history of scientific excellence and a presence across multiple continents, their passionate team is focused on developing transformative treatments in areas such as oncology, rare diseases, and immune disorders. Their mission is to improve patient outcomes through cutting-edge research and the delivery of impactful healthcare solutions.
About the Role:
This role will drive the development and execution of regulatory plans, ensuring alignment with organizational goals and effective collaboration with health authorities. The ideal candidate will have a strong background in US regulatory affairs, with expertise in guiding submissions from IND through NDA/BLA. This position also involves mentoring team members and fostering innovative approaches to regulatory challenges.
Key Responsibilities:
- Design and implement US regulatory strategies for assigned projects, ensuring alignment with organizational objectives.
- Lead the preparation and submission of regulatory filings, including briefing documents, breakthrough therapy requests, orphan drug applications, and BLA annual reports.
- Plan and execute FDA interactions, including meeting preparation, negotiation, and documentation of outcomes.
- Serve as a regulatory subject matter expert, providing guidance and mentorship to team members to develop cohesive and innovative strategies.
- Identify and address risks or misalignments, escalating issues to senior leadership with actionable solutions.
- Represent US regulatory affairs in global product team meetings, providing strategic input and managing day-to-day activities.
- Stay informed on evolving regulatory guidelines and industry trends through continuous learning and professional development.
Qualifications:
- Bachelor’s degree in chemistry, biology, or a related field (required).
- Advanced degree (PharmD, PhD, or Master’s) in a relevant discipline (preferred).
- 10+ years of experience in the pharmaceutical industry, with 8+ years in US regulatory affairs.
- Proven experience leading regulatory submissions and managing FDA interactions.
- Strong leadership, communication, and collaboration skills.
- Ability to travel up to 20% as needed.
Equal Opportunity Employer:
We are committed to creating a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Skills
FDA (Food and Drug Administration)
Job Reference
155690
Date Posted
6 Mar 2025
Industry
Pharmaceuticals
Category
Regulatory
Role
Regulatory Affairs Specialist
Level
Senior Leadership
Employment
Permanent
Working Location
Hybrid
Salary/Rate
250,000 USD
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