Vice President of Regulatory Affairs

Vice President of Regulatory Affairs

About the Company

Join a dynamic and innovative T-cell receptor biotechnology company making strides in the industry.

Industry
Biotechnology

Company Type
Public Company

Founded
2008

Employee Count
201-500

Categories

• Biotechnology
• B2B
• Health Care
• Medical
• Pharmaceutical
• Manufacturing
• Pharmaceuticals
• Medicine
• Chemical Products
• Academic Research
• Laboratory Services

Specialties

• Biotechnology
• Pharmaceuticals
• Immunooncology
• T-Cells
• Infectious Disease
• Oncology
• Immtacs
• Immune System
• Biologics
• Autoimmune Diseases
• Regulatory Affairs
• CMC
• Cancer
• Immunotherapy

About the Role

We are seeking a passionate and experienced Vice President of Regulatory Affairs to spearhead our regulatory strategy and compliance initiatives throughout the drug development lifecycle. This is an exciting opportunity to lead a dedicated team and influence the trajectory of innovative therapeutic solutions.

Your primary responsibilities will include:

• Developing and executing comprehensive regulatory strategies in collaboration with global regulatory leads.
• Ensuring timely and consistent document development and regulatory submissions.
• Overseeing interactions with regulatory agencies and aligning regulatory goals with business objectives.
• Providing strategic insights on labeling, risk management, and post-marketing obligations.

The ideal candidate will bring 15-20
years of regulatory experience in a biopharmaceutical setting, particularly in biologics drug development. Experience in oncology, anti-infectives, or autoimmune disease is highly desirable. You should have successfully led the preparation and submission of at least one New Molecular Entity (NME) and possess a strong educational background in a scientific discipline, with an advanced degree preferred.

To excel in this role, you must demonstrate:

• Exceptional communication skills with an ability to influence and build credibility.
• A strong track record of success in regulatory affairs.
• Leadership capabilities and a collaborative spirit.
• Adaptability in a fast-paced, innovative environment.

Join us in our mission to transform patient care through cutting-edge biotechnology solutions.

Hiring Manager Title
Senior Vice President of Regulatory Sciences

Travel Percentage
Less than 10%