Vice President, Regulatory Affairs

About the Company

Innovative biotechnology company specializing in Alzheimer's disease therapeutics & diagnostics

Industry
Biotechnology

Type
Public Company

Founded
1996

Employees
51-200

Categories

• Biotechnology
• Pharmaceuticals
• Academic Research
• Health Care
• Medical Care
• Medical Conditions
• Therapeutics
• Medical Diagnostics
• Medicines
• Life Sciences
• Medicine
• Manufacturing
• Chemical Products

Specialties

• Alzheimer's disease
• Neurodegenerative disease
• therapeutics
• amyloid-beta oligomers
• monoclonal anitbodies
• and immunotherapy

About the Role

The Company is in search of a Vice President, Regulatory Affairs to spearhead the development and execution of global regulatory strategies for its innovative therapies. The successful candidate will be at the forefront of shaping the regulatory roadmap, engaging with authorities such as the FDA and EMA, and driving the approval process for the company's portfolio, with a specific focus on CNS. This pivotal role demands a leader with an advanced degree in a relevant scientific discipline, a minimum of 10 years' experience in regulatory affairs within the biotech or pharmaceutical industry, and a proven track record in shepherding regulatory activities for novel treatments. Responsibilities include leading the preparation and submission of a range of regulatory documents, proactively identifying and addressing regulatory risks, and ensuring compliance with evolving guidelines and industry standards. The role also involves providing strategic guidance to cross-functional teams, advising on clinical study design, and overseeing the development of regulatory policies and best practices.The ideal candidate will have extensive experience in regulatory submissions, interactions, and approvals, and a strong ability to influence both internal and external stakeholders. While not mandatory, regulatory affairs certification (RAC) is desirable. The Vice President will also be expected to build and mentor a team of regulatory professionals, as well as engage with external partners to enhance regulatory strategy and execution. This is a unique opportunity to be part of a company at the forefront of Alzheimer's disease research, with a focus on a novel therapeutic approach.

Hiring Manager Title
Chief Development Officer

Travel Percent
Less than 10%

Functions

• Operations
• Strategy