Regulatory Strategy, Vice President (Bay Area, Boston)

About the role

Premier Research is seeking a Regulatory Strategy, Vice President to lead the Regulatory Affairs team in the Bay Area or Boston. This role involves transforming life-changing ideas into new medicines, devices, and diagnostics, with a focus on regulatory compliance and strategic planning.

Responsibilities

• Supervises, mentors, and motivates reporting associates in tasks and activities
• Develops and implements strategic plans and objectives for Premier in alignment with corporate strategy and revenue targets
• Participates in the development of corporate methods, techniques, and evaluation criteria for projects, programs, and people
• Consults and advises on laws, regulations, and guidelines related to clinical trials and regulatory submissions
• Prepares regulatory strategies, review clinical development plans, and produce regulatory submission materials
• Provides strategic and tactical guidance to clients and project teams
• Supports business development efforts and cross-sells Premier's clinical CRO services
• Partners with Marketing to develop resources and presentations
• Manages regulatory submissions in the US and Europe
• Maintains relationships with FDA, EMA, and other regulatory agencies
• Ensures compliance with regulatory requirements and timelines

Requirements

• Minimum BS or MS degree in a science-related field, with a PharmD or PhD preferred
• At least 15 years of regulatory experience, including at least 7 years in a management position
• Experience in preparing regulatory submissions in the US and Europe
• Experience supervising and managing a team
• Expertise in complex reasoning, risk management, and regulatory compliance
• Demonstrated knowledge of relevant laws, regulations, and guidelines
• Track record of successful FDA IND applications and product approvals

Qualifications

• Excellent written and verbal communication skills
• Strong interpersonal and motivational skills
• Proven ability to work in a multidisciplinary team environment
• Strong scientific background in a designated functional or therapeutic domain

Skills

• Strategic planning and implementation
• Regulatory compliance and legal knowledge
• Team leadership and supervision
• Project management and coordination
• Effective communication and presentation skills

Benefits

The annualized minimum base pay for this role is $200,000.00 USD. Additional benefits include health insurance, retirement plans, and paid time off.

Pay

$200,000.00 USD annually

Schedule

N/A