Vice President, Regulatory Affairs

Location

Maryland + 1 moreAll locations: Maryland | Massachusetts

Posted

1 day ago

Salary

$295.6K - $347.8K / year

Seniority

Lead

Bachelor Degree15 yrs expEnglish

Job Description

Vice President, Regulatory Affairs

Miltenyi Biotec

• Lead regulatory strategy for US Biomedicine efforts • Oversee industry-specific practices and ensure compliance with regulations • Manage regulatory submissions for clinical and CMC development • Advise on CMC-related regulatory activities • Identify and communicate potential project challenges

Job Requirements

  • B.S. or higher degree in the sciences or health-related field
  • 15 years of pharmaceutical/biotechnology industry regulatory experience
  • Extensive experience providing regulatory leadership through clinical and CMC development
  • Proven track record of leading NDA/BLA submissions
  • Demonstrated knowledge of drug development process in the US
  • Maintain current knowledge of industry-specific regulations

Benefits

  • Health, vision, and dental insurance
  • 401(k) plan

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