Manager, Study Start Up and Regulatory Affairs

ERGOMED

. Develop regulatory strategies based on regulatory requirements .

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

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing regulatory strategies and managing study start-up processes for medium- to high-complexity projects. Proven ability to build relationships with clients and regulatory authorities while providing strategic guidance and mentoring to team members.

Highest-signal resume keywords

Regulatory Strategy DevelopmentStudy Start-Up ManagementProject ManagementRegulatory Affairs ExpertiseClient Relationship Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Requirements KnowledgeProject Budget MonitoringRisk Assessment and MitigationClinical Site Agreement NegotiationStudy Document Review and Tracking

Soft Skills

Coaching and MentoringCommunicationTeam LeadershipStakeholder Engagement

Industry Keywords

Pharmaceutical IndustryCRO IndustryGlobal Project ManagementStudy Start-Up DeliverablesBusiness Development

About the role

Key responsibilities & impact

Develop regulatory strategies 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
Deliver study start-up and regulatory milestones end to end
Collect, review, and track essential study start-up documents
Investigate incomplete, inaccurate, or missing documents
Prepare study team reports and status updates
Negotiate and execute 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
Assign departmental deliverables, monitor project budgets and hours, and escalate out-of-scope work
Participate in business development meetings and contribute to proposals, regulatory costing, and budgets
Provide strategic input into bids and support new business opportunities
Coach, guide, and provide performance feedback to team members
May line manage staff and perform other assigned duties

Requirements

What you’ll need

Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience
6–8 years within the pharmaceutical or CRO industry or a regulatory body
At least 3 years in a leading/project management role
Proven ability to successfully manage global projects
Experience with study start-up and regulatory affairs
Knowledge of regulatory requirements and country regulations
Ability to manage projects of medium to high complexity
Ability to develop regulatory strategies and contribute to proposals, budgets, and bids
Ability to provide strategic regulatory guidance, training, coaching, and mentoring
Ability to monitor project budgets, hours spent versus budgeted, and identify out-of-scope work
Ability to build relationships with clients, regulatory authorities, and internal stakeholders

Benefits

Comp & perks

Collaborative, international team
Career growth opportunities
Flexible work environment
Work-life balance
Coaching, guidance, and performance feedback
Opportunity to work on meaningful clinical research supporting patients
Diverse and inclusive workplace
Supportive culture with shared ownership and trust