ERGOMED

Associate, Regulatory Intelligence and Analytics

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇭🇷 Croatia

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Job Level

JuniorMid-Level

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
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