ERGOMED

Associate, Regulatory Intelligence and Analytics

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: Croatia

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About the role

  • Provide intelligence on requirements and contribute to the development of the strategy and set up activities including Regulatory Management Plan, joint operating procedures, POAs and core documents.
  • Support identification of issues.
  • Perform regular screening of regulatory legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
  • Provide internal teams with 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 administrative support to BD activities.
  • 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.

Requirements

  • Degree in Chemistry or Life Sciences, Nursing or equivalent experience
  • Previous experience within the pharmaceutical/CRO industry not required, however preferred
  • 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
  • Proficiency in English, both written and verbal
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
Benefits
  • Diverse tasks - data mining, screenings, analysis, requirements review.
  • Chance to build a broad and comprehensive knowledge on PhV processes and requirements
  • Chance to expand knowledge on other areas covered by Regulatory department i.e. clinical trials, marketing authorisations, XEVMPD, PV Network
  • A role in development of RI processes in a motivating environment
  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Regulatory Management Planjoint operating proceduresregulatory intelligence databasecomplianceauditsinspectionsattention to detailplanningorganizational skillsproficiency in English
Soft Skills
communication skillsinterpersonal skillsself-motivationadministrative supportrelationship buildingproblem identificationrisk managementtime managementadaptabilityteam collaboration
Certifications
Degree in ChemistryDegree in Life SciencesDegree in Nursing