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Regulatory and Start Up Specialist at Precision Medicine Group - ApplyBlast

Regulatory and Start Up Specialist

Precision Medicine Group

2 months ago

2.9 on Glassdoor

Remote

Full Time

Medior

0 applicants

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About this role

The Regulatory and Start Up Specialist is responsible for ensuring timely and quality site activation readiness across assigned countries and sites. The role manages preparation and submission of clinical trial applications, interacts with competent authorities and ethics committees, and coordinates essential documentation and translations. It also supports study budget negotiations, site contracts, and maintains regulatory intelligence and audit readiness.

Responsibilities

Prepare and submit clinical trial applications to authorities
Coordinate site activation and manage essential documents
Maintain project plans and regulatory intelligence tools

Skills

Qualifications

Bachelor’s degree in life sciencesRegistered Nurse (RN)Pharmacy qualification / PharmacistMD/PhD/PharmDRAC certification

About Precision Medicine Group

precisionmedicinegrp.com

Headquarters

Bethesda, Maryland, United States

Company Size

1001-5000 employees

Founded

2012

View Profile

Precision Medicine Group (PMG) is a consulting and solutions firm that helps pharmaceutical and life‑science companies accelerate drug development and improve patient outcomes by applying the discipline of precision medicine. PMG brings together specialized expertise in data and evidence generation, manufacturing, market access, and stakeholder engagement to unlock insights and speed commercialization. Focused on delivering measurable value, the company partners with innovators to advance development, strengthen access, and "move science closer to health."