RemoteLeaf Logo
Log in Sign up

Regulatory and Site Start Up Specialist

3 hours ago
Australia
Full-time
Junior
Compliance Manager
Operations
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 65

Description

  • Deliver site activation readiness on time and with quality, while identifying and mitigating risks.
  • Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage interactions with Competent Authorities and Ethics Committees and handle their responses.
  • Provide regular updates on submission status and deliverables to startup, regulatory, project management, and project team stakeholders.
  • Maintain project plans, trackers, and regulatory intelligence tools for assigned responsibilities.
  • Support development of study start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to align communication and secure site review and essential document collection.
  • Customize patient information sheets and informed consent forms for country or site-specific requirements.
  • Coordinate translations of study documents and maintain compliance with local clinical trial laws and regulations.
  • Maintain audit and inspection readiness and file documents in the TMF according to study plans.
  • Support study budget negotiation, investigator contract execution, feasibility outreach, and pre-study site visits as needed.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, or RN, or equivalent education, training, and experience.
  • Pharmacy qualification or pharmacist work experience is highly beneficial.
  • 1+ year of experience as a Regulatory or Start Up specialist, or in a comparable role, within a CRO or pharmaceutical/biotech company.
  • Strong communication and organizational skills.
  • Experience with computerized information systems, electronic spreadsheets, word processing, 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 and meet deadlines is preferred.
  • Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or a Master’s in Regulatory Science is preferred.

Benefits

  • Opportunity to work on groundbreaking cancer therapies and other precision medicine research.
  • A collaborative environment where employees’ ideas are valued and nurtured.
  • Opportunity to provide input and help drive positive change within the company.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Carvana

Car Detailer

Carvana 10K-50K Automotive

Carvana is hiring a part-time entry-level Lot Attendant to maintain vehicle cleanliness and presentation at its Market Hubs while supporting timely deliveries and customer satisfaction.

United States Part-time Entry Level Operations Specialist
$35k-$37k
15 minutes ago
ABC Legal Services

Data Entry Specialist, Remote

ABC Legal Services 251-1K Specialized Consumer Services

ABC Legal Services is hiring a remote e-File Specialist in Wisconsin to review and file legal documents through internal online platforms and support the e-Fulfillment and e-Filing team’s daily operations.

United States Full-time Entry Level Operations Specialist
$31k-$31k
15 minutes ago
GoFasti

1068- Intake and QA expert (home health services)

GoFasti 51-250 Internet Software & Services

GoFasti is hiring an English-fluent Intake and QA Expert for home health services to work remotely from Latin America, ensuring clinical documentation, referrals, and patient intake processes are accurate, compliant, and timely.

Latin America Contract Junior Operations Specialist QA Engineer
$2k-$2k
30 minutes ago
Nebius

Compliance Due Diligence Specialist

Nebius 51-250 Internet Software & Services

Nebius is hiring a Compliance Due Diligence Specialist to support third-party risk management and due diligence assessments for a fast-growing AI cloud company.

Netherlands United States Full-time Mid Level Compliance Manager
45 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