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Principal Regulatory and Start Up Specialist

1 hour, 32 minutes ago
Turkey
Full-time
Senior
Operations Specialist
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 129

Description

  • Deliver timely, high-quality site activation readiness for assigned countries and sites while identifying and mitigating risks.
  • Drive country-level submissions and site activation processes when multiple RSSs are assigned within a country.
  • 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 and responses with competent authorities and ethics committees for study submissions.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership informed of status and risks.
  • Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs and cross-functional teams, including Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts.
  • Prepare, review, and manage essential documents needed for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country- and site-specific requirements.
  • Coordinate translations for submission documents and support local regulatory compliance and audit/inspection readiness.
  • Serve as a subject matter expert for country start-up timelines, site activation critical path items, and local regulatory requirements.
  • Support study budget and investigator contract negotiations when required and help drive start-up activities for smaller or regional studies.
  • Mentor staff on local regulations, submission processes, internal procedures, and start-up tools.
  • Contribute to process improvements, training development, and client-facing status updates or presentations as needed.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare discipline, or Registered Nurse (RN), or equivalent education, training, and experience.
  • 5 or more years of experience as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech environment, or equivalent relevant experience.
  • Excellent communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English and Turkish.
  • Ability to prioritize workload and meet deadlines.
  • Experience driving cross-functional activities, coordination, and team oversight.
  • Relevant country-specific regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions, preferred.
  • Experience in country set-up, preferred.
  • Experience using milestone tracking tools and systems, preferred.
  • Ability to assist junior Start Up specialists in problem resolution, preferred.
  • Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or a Master’s in Regulatory Science, preferred.
  • Knowledge of Good Clinical Practice, ICH guidelines, and other applicable regulatory requirements, preferred.
  • Strong attention to detail and accuracy, and ability to work independently in a fast-paced environment, preferred.
  • Excellent computer, presentation, interpersonal, written, and spoken communication skills, preferred.
  • Flexibility with work assignments, new learning, and occasional travel, preferred.

Benefits

  • Remote work designation (#LI-Remote).
  • Opportunity to work on groundbreaking cancer therapies and other precision medicine studies.
  • Employee contributions are appreciated and ideas are valued and nurtured.
  • Equal Opportunity Employer environment.
  • Reasonable accommodation available for applicants with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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