Vice President, Regulatory Strategy

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Oversees, guides, and inspires team members who report directly to them

• Creates and executes strategic plans and objectives

• Engages in the formulation of corporate methodologies, techniques, and assessment criteria

• Provides consultation and advice regarding laws, regulations, and guidelines pertaining to clinical trials

• Establishes and nurtures a strong working relationship with the FDA, EMA, and other regulatory bodies

• Takes a leadership role in crafting regulatory strategies

• Offers strategic and tactical direction to clients

• Collaborates with Business Development to promote Premier’s clinical CRO services

• Delivers presentations at relevant industry events

• Undertakes additional responsibilities and tasks as assigned

⛳️ Requirements

• A minimum of a BS or MS degree in a science-related discipline

• A PharmD or PhD degree is highly desirable

• At least fifteen years of regulatory experience within the pharmaceutical, CRO, biotechnology, or consulting sectors

• A minimum of seven years in a leadership role within a regulatory affairs department

• At least ten years of experience in team management

• Experience in preparing regulatory submissions in the US and/or Europe

• Background in supervisory and financial management duties

• Experience collaborating in multidisciplinary project teams

• Proven ability in complex reasoning and risk management

• Exceptional written and verbal communication along with presentation skills

• Strong interpersonal, motivational, and team-building capabilities

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off