ERGOMED

Senior Specialist/Manager, Regulatory Intelligence and Analytics

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: Bosnia and Herzegovina

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
  • Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database
  • Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk
  • Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
  • Ensure compliance with company procedures, processes, training records, systems and any other tools
  • Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated
  • Monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
  • Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
  • Provide training, coaching and mentoring to junior members of staff
  • Foster professional working relationships with internal and external contacts at the local and international levels

Requirements

  • Degree in Chemistry or Life Sciences, Nursing or equivalent experience
  • Strong previous experience within pharmaceutical or CRO industry or Regulatory body
  • Previous Project Management experience is desirable
  • Knowledge of Pharmacovigilance/Regulatory field
  • Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency
  • Fluent Proficiency in English, both written and verbal
  • Additional languages are desirable
  • Strong organization skills and detailed orientated approach to work
Benefits
  • 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
Project ManagementRegulatory IntelligenceQuality ControlPharmacovigilanceICH GCPGVPRegulatory ComplianceBudget MonitoringTrainingCoaching
Soft Skills
LeadershipProblem SolvingCommunicationOrganizational SkillsDetail OrientationRelationship BuildingMentoringStrategic InputRisk ManagementTeam Coordination