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About the Role

Premier Research is seeking a Vice President of Regulatory Strategy to lead efforts in transforming breakthrough science into new medicines, devices, and diagnostics. This role involves supervising teams, developing strategic regulatory plans, and advising clients on global clinical trial and marketing authorization requirements to drive innovation for patients.

Responsibilities

• Supervise, mentor, and motivate reporting associates while conducting performance reviews and participating in hiring.
• Develop and implement strategic plans aligned with corporate objectives and revenue targets.
• Manage project budgets, oversee staff productivity, and approve client invoices.
• Provide expert-level consultation on laws, regulations, and guidelines for clinical trials in the US, Europe, and globally.
• Maintain relationships with the FDA, EMA, and other regulatory agencies to execute international and regional strategies.
• Lead the preparation of regulatory strategies, clinical development plans, and submission materials.
• Provide strategic and tactical guidance to drive backlog and revenue growth.
• Partner with Business Development to cross-sell clinical CRO services and support Marketing-led campaigns.
• Present at industry engagements to project company expertise.

Requirements

• Minimum BS or MS degree in a science-related field; PharmD or PhD preferred.
• Minimum of 15 years of regulatory experience in pharmaceutical, CRO, biotechnology, or consulting industries.
• At least 7 years of experience in a management position within a regulatory affairs department.
• Minimum 10 years of experience managing a team.
• Experience in the preparation of regulatory submissions in the US and/or Europe.
• Experience with supervisory and financial management responsibilities.
• Experience working in multidisciplinary project teams.
• Demonstrated track record of successful FDA IND applications and product approvals.

Skills

• Complex reasoning
• Risk management
• Risk-benefit and cost-benefit assessments
• In-depth knowledge of ICH territory regulations
• Knowledge of pre-clinical, chemistry, manufacturing, and controls (CMC) regulations
• Written and verbal communication
• Presentation skills
• Persuasion and influence
• Interpersonal and team-building skills
• Scientific acumen

Location

• San Francisco, CA
• Boston, MA

Work Type

• Full-time

Experience Level

• 15+ years of regulatory experience
• 10+ years of management experience

Education Level

• BS or MS in a science-related field
• PharmD or PhD preferred

Salary/Compensations

• $200,000.00 USD minimum base pay

Benefits

• Health insurance
• Retirement plans
• Paid time off

About the Company

• Global clinical research, product development, and consulting company.
• Dedicated to helping biotech, specialty pharma, and MedTech innovators.
• Values include Aiming High, Working Together, Staying Agile, Getting It Done, and Caring.

Equal Opportunity

• Equal opportunity employer compliant with all federal guidelines.
• Equitable consideration provided without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.