Senior Vice President, Regulatory and Product Strategy jobs in United States
cer-icon
Apply on Employer Site
company-logo

Premier Research ยท 5 hours ago

Senior Vice President, Regulatory and Product Strategy

Premier Research is looking for a Senior Vice President, Regulatory and Product Strategy to join our Regulatory Affairs team. In this role, you will lead integrated strategies across regulatory affairs and clinical development, ensuring client service excellence while driving organizational growth and collaboration.

BiopharmaBiotechnologyHealth CarePharmaceutical
check
H1B Sponsor Likelynote
Hiring Manager
Alyssa Byczek
linkedin

Responsibilities

Lead integrated Regulatory Strategy, Regulatory Affairs, Commercial Strategy, and Clinical Development Strategy services to meet client needs
Drive organizational design and development, including building a contractor network to complement in-house capabilities
Monitor industry trends and implement plans to achieve revenue and margin growth aligned with corporate goals
Foster strong collaboration across consulting and clinical development functions to ensure client service excellence
Oversee operational performance, budgets, and proposal templates to maintain consistency and profitability
Represent the organization with regulatory agencies and in the scientific community while maintaining compliance knowledge globally

Qualification

Regulatory submissions expertiseGlobal drug development regulationsLeadership experienceFinancial acumenStrategic decision-makingComplex reasoningRisk management

Required

Advanced degree in a science-related field (PharmD or PhD preferred)
20+ years in pharma, CRO, or biotech, including 10+ years of leadership experience
Proven expertise in regulatory submissions support for US and Europe, plus IND applications and product approvals
Strong financial acumen with experience managing budgets and driving business development
In-depth knowledge of global drug development regulations, including clinical, pre-clinical, and manufacturing requirements
Demonstrated ability in complex reasoning, risk management, and strategic decision-making

Preferred

PharmD or PhD
Remote based opportunity, however priority consideration for those physically located in San Francisco or Boston

Benefits

Health insurance
Retirement plans
Paid time off

Company

Premier Research

company-logo
Premier Research is a biotech startup that helps biopharmaceutical and medical device companies bring their developments.

H1B Sponsorship

Premier Research has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (10)
2023 (9)
2022 (19)
2021 (17)
2020 (6)

Funding

Current Stage
Late Stage
Total Funding
unknown
Key Investors
Metalmark Capital
2016-10-17Series Unknown
2008-03-20Acquired

Leadership Team

leader-logo
Ellen Teplitzky
Senior Vice President, Legal Affairs and Chief Compliance Officer
linkedin
Company data provided by crunchbase