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About the Role

This role supports biotech, medtech, and specialty pharma companies in developing new medical treatments. It is crucial for delivering medical innovation and improving lives, offering growth opportunities, flexibility, and a platform for team members' ideas to influence work.

Responsibilities

• Develop and execute regulatory program strategies and contingencies for assigned projects
• Lead US and ex-US regulatory teams on assigned projects
• Develop and implement creative approaches to ensure regulatory success
• Provide efficient and effective regulatory representation with clients and across the organization
• Act as a key player in interactions with the Food and Drug Administration (FDA) and other regulatory agencies
• Serve as the primary point of contact and interface for FDA/EMA/national agencies on assigned projects
• Lead the preparation of submissions, including INDs, briefing documents, orphan drug applications, breakthrough designations, and NDAs/BLAs/MAAs

Requirements

• Bachelor’s degree, or international equivalent from an accredited institution, in science or health related field
• 12+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry
• 8-9 years progressive regulatory affairs experience (US and/or ex-US) for a CRO/biotech/pharma
• 4+ years as a consultant within regulatory affairs experience
• Demonstrated experience interacting with the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies
• Demonstrated leadership experience in the opening of INDs and submission and approvals of NDAs/BLAs/MAAs
• Expert in the drug development process with experience in multiple phases (early and late stage, post-approval) in various therapeutic areas and product types (drugs, biologics, drug-drug combinations, drug-device combination products)

Location

• Bay Area
• Boston
• San Francisco

Experience Level

• 12+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry
• 8-9 years progressive regulatory affairs experience (US and/or ex-US)
• 4+ years as a consultant

Education Level

• Bachelor’s degree, or international equivalent from an accredited institution, in science or health related field
• Master’s Degree or PhD preferred

Salary/Compensations

• Annualized minimum base pay: $150,000.00 USD

Benefits

• Comprehensive benefits package
• Health insurance
• Retirement plans
• Paid time off

About the Company

• Premier Research is a community furthering research to improve the lives of patients in critical need.
• We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.
• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust our team embodies.
• Team members have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unique.
• We provide staff with innovative technologies and continuous learning.
• Premier Research is a global clinical research, product development, and consulting company.
• We help biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments.
• Our team is inspired by this common purpose.
• Premier is a place where you can change lives, and feel rewarded and celebrated.
• We aim high and will not stop until we reach our goals.
• We care about each other, our customers and partners, and all the patients we touch with our work.

Equal Opportunity

• Premier Research is an equal opportunity employer compliant with all federal guidelines.
• All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.