Vice President, Regulatory Operational Excellence

About the Company

Clinical-stage biopharmaceutical company for auto-immune diseases

Industry
Biotechnology

Type
Privately Held

Founded
2018

Employees
51-200

Categories

• Biotechnology
• Manufacturing
• Pharmaceuticals
• Medicine
• Chemical Products
• Academic Research
• Laboratory Services

Specialties

• Autoimmune disease

About the Role

The Company is seeking a Vice President of Regulatory Operational Excellence to lead and optimize multiple groups within the Regulatory Affairs department. This role is pivotal in driving operational transformation to align with the company's objectives of developing high-value therapies for patients with autoimmune diseases. The successful candidate will be responsible for overseeing regulatory operations, regulatory business operations, and medical writing, ensuring compliance with regulations, GxP standards, internal, and external guidelines. Key responsibilities include managing a team of regulatory personnel, managing department budgets, developing and implementing document templates and writing standards, and fostering the growth and development of the regulatory affairs team.Applicants must have a Bachelor's degree in a scientific discipline, with an advanced degree highly desired, and a minimum of 12-15 years' of regulatory industry experience in biopharmaceuticals. Experience with Veeva and the implementation of new processes within Veeva is essential, as is a strong background in regulatory support of clinical trials, including hands-on or oversight experience in regulatory operations, submission management, and regulatory writing. The role requires a candidate with a proven track record of managing multiple functions and people, strong communication skills, and the ability to lead in a dynamic, fast-paced environment. Experience with clinical stage assets is mandatory, with experience in BLA and post-marketing activities strongly preferred. The candidate should also have a strong understanding of drug development, FDA, EMA, and other regulatory guidelines and regulations.

Hiring Manager Title
Senior Vice President of Regulatory Affairs

Team Size
6

Travel Percent
20%

Functions

• Operations
• General Management