Principal Regulatory and Start Up Specialist
Precision Medicine Group
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.
- Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
- Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
- Prepare, review and manage collection of essential documents required for site activation/IMP release.
- Customize country/site specific Patient Information Sheet and Informed Consent Forms.
- Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
- Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
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.
- 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.
Benefits
- We strive to ensure employees feel appreciated for the contributions they make every single day.
- You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
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 intelligence toolsstudy specific start-up plansIMP release requirementsessential document reviewPatient Information SheetInformed Consent Formstranslation coordinationICH-GCP
Soft Skills
communication skillsorganizational skillsability to prioritize workloadteam coordinationcross-functional activities oversight
Certifications
Bachelors’ degree in life sciencesRegistered Nurse (RN)