Manager, Study Start Up and Regulatory Affairs

ERGOMED

. Develop regulatory strategy and coordinate and oversee study start-up deliverables from site selection through site initiation readiness .

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

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing regulatory strategies and managing study start-up processes within the pharmaceutical or CRO industry. Proven ability to lead global projects, negotiate clinical agreements, and mentor team members while ensuring compliance with regulatory requirements.

Highest-signal resume keywords

Regulatory Strategy DevelopmentStudy Start-Up ManagementClinical Site Agreement NegotiationRisk Assessment and MitigationProject Budget Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsProject ManagementClinical Trial ManagementBudget DevelopmentProposal WritingRisk ManagementDocument ReviewStudy Milestone TrackingEssential Document ManagementGlobal Project Management

Soft Skills

Team LeadershipMentoringClient Relationship BuildingCommunicationProblem Solving

Industry Keywords

Pharmaceutical IndustryCRO IndustryRegulatory RequirementsStudy Start-UpClinical TrialsAncillary AgreementsSite SelectionStakeholder CoordinationBusiness DevelopmentPerformance Feedback

About the role

Key responsibilities & impact

Develop regulatory strategy and coordinate and oversee study start-up deliverables from site selection through site initiation readiness
Lead study start-up and regulatory activities for medium- to high-complexity projects
Manage end-to-end study start-up and regulatory milestones
Collect, review, track, and resolve issues with essential study documents
Prepare study team reports and status updates
Negotiate and execute clinical site agreements, ancillary agreements, and amendments
Define and implement project-level study start-up and regulatory strategies
Identify, assess, and mitigate risks affecting timelines
Build relationships with clients, regulatory authorities, and internal stakeholders
Coordinate departmental deliverables, monitor 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, mentor, and provide performance feedback to team members
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 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 activities
Knowledge of regulatory requirements and country regulations
Ability to manage clinical site agreements, ancillary agreements, amendments, and essential documents
Ability to develop regulatory strategies, proposals, regulatory costing, and budgets
Ability to identify, assess, and mitigate study start-up and regulatory risks
Ability to monitor project budgets and escalate out-of-scope work

Benefits

Comp & perks

Collaborative, international team environment
Career growth opportunities
Flexible work culture
Work-life balance
Coaching, guidance, and performance feedback
Opportunity to contribute to meaningful work helping bring safe and effective pharmaceutical treatments to patients
Diverse and inclusive workplace where every voice counts