Vice President, Regulatory Affairs

Miltenyi Biotec

Lead regulatory strategies for US Biomedicine efforts at Miltenyi Biotec. Oversee submissions and ensure compliance with regulations while managing cross-functional teams.

Posted 6/24/2026full-timeRemote • Maryland, Massachusetts • 🇺🇸 United StatesLead💰 $295,600 - $347,764 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Comp & perks

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

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory strategyregulatory submissionsclinical developmentCMC developmentNDA submissionsBLA submissionsdrug development process

Soft Skills

leadershipcommunicationproblem-solving

Certifications

B.S. degreehigher degree in sciences or health-related field