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Premier Research

We’re Built for Biotech℠, dedicated to helping today’s top innovators turn big ideas into life-changing treatments.

Vice President, Regulatory Strategy

ComplianceComplianceFull TimeRemoteLeadTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

Location

California + 1 moreAll locations: California | Massachusetts

Posted

2 days ago

Salary

$200K / year

Seniority

Lead

Postgraduate Degree15 yrs expEnglish

Job Description

Vice President, Regulatory Strategy

Premier Research

• 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

Job 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

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