Principal Regulatory and Start Up Specialist
Precision For Medicine
full-time
Posted on:
Location Type: Remote
Location: Turkey
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Job Level
Tech Stack
About the role
- Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
- Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country.
- Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
- Interaction with CA/EC for study purposes and handling responses to the CA/EC.
- Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
Requirements
- Bachelors’ degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
- 5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Must demonstrate excellent computer skills.
Benefits
- Excellent communication and organizational skills are essential.
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
- Fluency in English and Turkish.
- Ability to prioritize workload to meet deadlines.
- Experience in driving cross-functional activities, coordination and oversight of a team.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Trial Application Formssubmission dossier preparationregulatory submissionsproject plans maintenanceproject trackersregulatory intelligence toolsrisk mitigationtimeliness managementquality assuranceGood Clinical Practice
Soft Skills
coordinationcommunicationinterpersonal skillsorganizational skillsproblem-solvingattention to detailteam collaborationupdates provisionresponsibilityleadership
Certifications
Bachelor's degree in life sciencesRegistered Nurse (RN)Regulatory Affairs Certification (RAC)Clinical Research Associate CertificationGood Clinical Practice CertificationClinical Research Coordinator CertificationCertified Clinical Research AssociateCertified Clinical Research CoordinatorISO 14155 CertificationICH-GCP Training