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Regulatory and Start Up Specialist / Senior Regulatory and Start Up Specialist

5 hours, 38 minutes ago
Turkey
Full-time
Senior
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 88

Description

  • Deliver site activation readiness for assigned country/sites on time and with high quality, while identifying and mitigating risks.
  • Drive country-level submissions and site activation processes when multiple Regulatory and Start Up Specialists are assigned.
  • Prepare Clinical Trial Application forms and submission dossiers, including initial submissions, amendments, and notifications to competent authorities, ethics committees, and other local bodies.
  • Interact with competent authorities and ethics committees, respond to questions, and provide submission status updates to study leadership and project teams.
  • Maintain project plans, trackers, regulatory intelligence tools, and study documentation to support leadership visibility and audit/inspection readiness.
  • Develop and support study-specific start-up plans, investigational product release requirements, and essential document review criteria.
  • Partner with site CRAs and cross-functional teams to ensure communication alignment, site collaboration, and coordinated start-up execution.
  • Prepare, review, and manage essential documents for site activation and investigational product release.
  • Customize patient information sheets and informed consent forms for country/site requirements and coordinate document translations.
  • Support budget negotiation, investigator contract execution, pre-study site visits, feasibility outreach, training sessions, mentoring, and process improvement initiatives as needed.

Requirements

  • Bachelor’s degree in life sciences or a related scientific/healthcare field, or Registered Nurse (RN), or an equivalent combination of education, training, and experience.
  • 5+ years of experience as a Regulatory or Start-Up Specialist in a CRO, pharmaceutical, or 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 regulatory and site start-up experience for the specific country, including feasibility, contract negotiations, and CA/EC/IRB submissions.
  • Experience with country start-up and milestone tracking tools/systems.
  • Ability to assist junior start-up specialists in problem resolution.
  • 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 applicable regulatory requirements.
  • Strong attention to detail, accuracy, computer skills, and the ability to work independently in a fast-paced environment.
  • Excellent presentation, interpersonal, written, and spoken communication skills with the ability to influence and persuade.
  • Flexible attitude toward work assignments and new learning; occasional travel may be required.

Benefits

  • Remote work flexibility, as indicated by the #LI-Remote posting.
  • Opportunity to work on groundbreaking cancer and rare disease therapies.
  • A culture that values employee input and nurtures ideas.
  • Equal opportunity employment with protections against discrimination.
  • Reasonable accommodation support for applicants with disabilities.
  • Access to a growing organization with cross-functional exposure and professional development opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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