Vice President, Regulatory Strategy

🔥 0 minutes ago

🏄 California, Massachusetts – Remote

🏄 California – Remote 🍂 Massachusetts – Remote

💵 $200k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Premier Research

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Venture Round on 2016-10

Biotechnology • Healthcare Insurance • Pharmaceuticals

Premier Research is a company dedicated to helping biotech companies transform groundbreaking scientific ideas into life-changing medical treatments. They specialize in clinical research and development, product development and regulatory consulting, and offer expertise in areas such as oncology, hematology, rare diseases, cell and gene therapy, and pediatrics, among others. Premier Research is committed to boosting clinical development strategies and guiding innovations from molecule to market. They provide a range of services that support biotech firms in navigating the complex path to medical approval, with a focus on rare diseases and innovative therapies.

📋 Description

• Supervises, mentors, and motivates reporting associates • Develops and implements strategic plans and objectives • Participates in the development of corporate methods, techniques and evaluation criteria • Consults and advises on laws, regulations, and guidelines on clinical trials • Develop and maintain an excellent working relationship with the FDA, EMA and other regulators • Provides leadership in the preparation of regulatory strategies • Provides strategic and tactical guidance to clients • Partners with Business Development to cross-sell Premier’s clinical CRO services • Presents at applicable industry engagements • Performs additional duties and assignments as requested

🎯 Requirements

• Minimum BS or MS degree in a science-related field • A PharmD or PhD degree is preferred • Minimum of fifteen years regulatory experience in the pharmaceutical, CRO, biotechnology or consulting industry • At least seven years in a management position in a regulatory affairs department • Minimum ten years of experience managing a team • Experience in preparation of regulatory submissions in the US and/or Europe • Experience with supervisory and financial management responsibilities • Experience working in multidisciplinary project teams • Demonstrated skills in complex reasoning, risk management • Excellent written/verbal communication and presentation skills • Excellent interpersonal, motivational and team building skills

🏖️ Benefits

• health insurance • retirement plans • paid time off