Regulatory Intelligence and Analytics Specialist
ERGOMED
full-time
Posted on:
Location Type: Remote
Location: Serbia
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Tech Stack
About the role
- Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
- Provide internal teams and Clients with expertise and guidance on national requirements.
- Ensure compliance with company procedures, processes, training records, systems and any other tools· Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
- Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
- Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
- Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
- Provide feedback on performance of vendors to aid their assessment.
- Communicate suggestions for changes to departmental/company processes/procedures and contribute to department initiatives.
Requirements
- Degree in Chemistry or Life Sciences, Nursing or equivalent experience
- Minimal previous experience within the pharmaceutical/CRO industry
- Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency
- Good planning and organizational skills
- Good written and verbal communication skills to clearly and concisely present information
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Good attention to detail
- Excellent self-motivation skills
- Basic understanding of ICH GCP across all areas
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory intelligencequality controlbudgetingproposal developmentauditsinspectionsattention to detailplanningorganizational skillscommunication
Soft Skills
interpersonal skillsself-motivationadaptabilityteam collaborationproblem-solvingrisk identificationfeedback provisionprocess improvementrelationship buildingtime management
Certifications
degree in Chemistrydegree in Life Sciencesdegree in NursingICH GCP knowledgeGVP knowledge