Senior Regulatory Officer

We are looking for a Senior Regulatory Officer to strengthen our team!

While our preference is for the ideal candidate to be based in Slovakia, we are open to considering candidates from Czech Republic, too.

The Senior Regulatory Officer will provide regulatory guidance, regulatory-scientific advice and strategic input for clinical trials and authorization of medicinal products and medical devices.

Job Responsibilities:

• Operates in accordance with local and international regulations, SanaClis/Sponsor SOPs (as applicable), and study protocol.
• Maintains the most up-to-date regulatory intelligence on all locations where SanaClis operates and laws SanaClis needs to comply with.
• Regularly reviews status of regulatory requirements on an international and country level.
• Utilizes relevant IT global systems used in pharmaceutical-regulatory environment and formats (e.g., eCTD, EudraCT, EudraGMP, CESP, CTIS, OMS)
• Coordinates collection of core scientific documentation needed for submission to RA/EC and provides feedback gap analysis to customers.
• Provides regulatory-scientific advice and expertise in clinical trials, medical device trials, and registration of pharmaceutical products.
• Ensures submission of all relevant information and documents via CTIS portal, as well as transitioning of ongoing studies as required by Regulation.
• Prepares and delivers regulatory-scientific trainings and advice to SanaClis employees and other parties if applicable (e.g., vendors, clients).
• Ensures that SanaClis Regulatory SOP/WIs/SFs are in line with international and local regulatory requirements and standards.
• Performs quality check of Clinical Trial Application Dossier in terms of regulatory requirements and obtained CA & EC approvals.
• Helps with creation/revision of country specific working instructions on the area of regulatory requirements.
• Prepares IMP/NIMP labels and/or coordinates regulatory review of IMP/NIMP labels.
• Maintains regulatory activity’s KPIs.

• Competitive salary.
• Flexible working hours and home-based working option.
• Great work-life balance.
  
• Career growth and development opportunities in a continuous learning culture.
• Friendly environment in a privately owned international company.
• Additional paid day off on your birthday.