RemoteLeaf Logo
Log in Sign up

Regulatory and Start Up Specialist

1 hour, 39 minutes ago
France
Full-time
Mid Level
Program Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 48

Description

  • Ensure site activation readiness within assigned countries and sites by delivering work on time and with quality while identifying and mitigating risks.
  • Prepare Clinical Trial Application forms and submission dossiers for initial submissions, amendments, and notifications to Competent Authorities, Ethics Committees, and other local bodies.
  • Manage interactions with Competent Authorities and Ethics Committees, including handling questions and responses related to study submissions.
  • Provide regular status updates on submissions and start-up progress to Regulatory Leadership, the Start Up Lead, Project Manager, and project team.
  • Maintain project plans, trackers, and regulatory intelligence tools tied to assigned responsibilities.
  • Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs and other functions to align communication and secure review and collection of essential documents for site activation and IMP release.
  • Customize country- or site-specific Patient Information Sheets and Informed Consent Forms and coordinate document translations.
  • Act as a subject matter expert on site activation timelines, site contracts, budget negotiation requirements, and other critical path data points.
  • Support study budget negotiations, investigator contract execution, feasibility outreach, and pre-study site visits as needed.
  • Maintain audit and inspection readiness and file documents in the TMF according to TMF plans and study-specific requirements.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, or Registered Nurse (RN), or equivalent education, training, and experience.
  • Pharmacy qualification or pharmacist work experience is highly beneficial.
  • Demonstrated experience as a Regulatory or Start Up specialist, or in a comparable role, within a CRO, pharmaceutical, or biotech environment.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing software, and email.
  • Fluency in English.
  • Relevant regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions, is preferred.
  • Experience using milestone tracking tools or systems is preferred.
  • Ability to prioritize workload to meet deadlines is preferred.
  • Advanced degree in medical or life sciences (MD, PhD, or PharmD), RAC certification, or a Master’s in Regulatory Science is preferred.

Benefits

  • Remote work designation (#LI-Remote).
  • Equal Opportunity Employer protections across race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other protected characteristics.
  • Reasonable accommodation available for applicants with disabilities during the application process.
  • Privacy policy and California applicant privacy notice provided for applicant data protection.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Attain Partners

ERP Finance Manager - Higher Education

Attain Partners 251-1K Media

Attain Partners is hiring a seasoned manager to support a Workday Finance ERP implementation for higher education clients, helping universities replace legacy finance systems while coordinating leadership and project execution.

United States Full-time Senior Accounting Manager Program Manager
$160k-$190k
9 minutes ago
Precision Medicine Group

Associate Start up Lead

Precision Medicine Group 251-1K Pharmaceuticals

Precision for Medicine is hiring a remote Associate Start Up Lead to oversee country and regional site start-up activities and drive timely site activation across assigned studies.

Poland Romania Serbia Slovakia Hungary Full-time Junior Program Manager
$4k-$6k
9 minutes ago
Airbnb

Senior Programs & Business Operations Lead, Airbnb Services

Airbnb 5K-10K Hotels, Restaurants & Leisure

Airbnb is hiring a Sr. Programs & Business Operations Lead to drive the global expansion of its Services business by taking new travel-adjacent categories from concept to launch and scale.

United States Full-time Lead Operations Analyst Program Manager
$204k-$249k
SQL
24 minutes ago
Puck

PACS Program Administrator

Puck 1-10 Internet Software & Services

Prenuvo is hiring a PACS Program Administrator to own and optimize imaging system operations and clinical workflows that support radiology performance, diagnostic quality, and patient care across a multi-site healthcare environment.

Canada Full-time Senior Program Manager
$105k-$120k
HIPAA
24 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers