Senior Manager, Regulatory Intelligence and Analytics

ERGOMED

. Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables .

Posted 5/2/2026full-timeRemote • 🇧🇦 Bosnia and HerzegovinaSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
Driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures.
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 to ensure smooth and efficient service delivery.
Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required.
Provide feedback on performance of vendors to aid their assessment.
Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.

Requirements

What you’ll need

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

Comp & perks

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

ATS Keywords

✓ Tailor your resume

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 GCPGVPbudget monitoringSOP designaudits preparationregulatory compliance

Soft Skills

leadershipproblem solvingcommunicationcoachingmentoringorganizational skillsrelationship buildingattention to detailrisk managementteam coordination