Manager, Study Start Up and Regulatory Affairs

ERGOMED

. Develop study start-up and regulatory strategy based on regulatory requirements .

Posted 11/11/2026full-timeRemote • CroatiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing study start-up and regulatory strategies, managing complex projects, and ensuring compliance with regulatory requirements. Proven ability to lead teams, manage budgets, and contribute to business development within the pharmaceutical or CRO industry.

Highest-signal resume keywords

Study Start-Up ManagementRegulatory Affairs ExpertiseProject Management LeadershipRisk Assessment and MitigationBusiness Development Contribution

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory RequirementsStudy Start-Up ActivitiesClinical Site AgreementsProject Budget ManagementDocument Compliance ReviewGlobal Project ManagementRisk Mitigation StrategiesProposal DevelopmentPerformance FeedbackNegotiation Skills

Soft Skills

Relationship BuildingCoaching and GuidanceCommunication SkillsTeam LeadershipProblem-Solving

Industry Keywords

Pharmaceutical IndustryCRO IndustryLife SciencesClinical TrialsRegulatory BodyStudy Initiation ReadinessAncillary AgreementsBudget MonitoringStakeholder EngagementProject Milestones

About the role

Key responsibilities & impact

Develop study start-up and regulatory strategy based on regulatory requirements
Coordinate and oversee study start-up deliverables from site selection through site initiation readiness
Lead study start-up and regulatory activities for assigned medium- to high-complexity projects
Manage end-to-end study start-up and regulatory milestones
Collect, review for completeness and compliance, and track essential study start-up documents
Investigate incomplete, inaccurate, or missing documents
Prepare study team reports and status updates on essential document collection, review, and approval
Ensure negotiation and execution of clinical site agreements, ancillary agreements, and amendments
Identify, assess, and mitigate risks affecting study start-up and regulatory timelines
Build and maintain relationships with clients, regulatory authorities, and internal stakeholders
Monitor project tasks, allocated time, budgets, and hours spent versus budgeted hours; escalate out-of-scope issues
Support business development by participating in BDMs and contributing to proposals, regulatory sections, costing, and budgets
Provide strategic input into bids and support new business opportunities
Provide coaching, guidance, and performance feedback to team members
Assist senior management in securing new business
May line manage staff
Perform other assigned work-related duties

Requirements

What you’ll need

Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience
6–8 years of experience within the pharmaceutical or CRO industry or a regulatory body
At least 3 years of experience in a leading/project management role
Proven ability to successfully manage global projects
Experience with regulatory requirements and regulatory affairs
Experience in study start-up activities and regulatory activities
Ability to develop study start-up and regulatory strategies
Ability to manage projects of medium to high complexity
Knowledge of clinical site agreements, ancillary agreements, amendments, and country regulations
Ability to identify, assess, and mitigate risks affecting study start-up and regulatory timelines
Ability to manage project budgets and monitor hours against budgets
Ability to contribute to business development meetings, proposals, regulatory costing, and budgets

Benefits

Comp & perks

Collaborative, international team environment
Career growth opportunities
Flexible work culture
Work-life balance
Coaching, guidance, and mentoring opportunities
Opportunity to contribute to meaningful work bringing safe and effective pharmaceutical treatments to patients
Collaboration with experts in clinical research, pharmacovigilance, and quality consulting