Manager, Study Start Up and Regulatory Affairs

ERGOMED

. Develop regulatory strategies based on regulatory requirements .

Posted 11/11/2026full-timeRemote • BulgariaMid-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 global projects. Proven ability to lead teams, negotiate clinical agreements, and ensure compliance with regulatory requirements.

Highest-signal resume keywords

Regulatory Strategy DevelopmentStudy Start-Up ManagementProject ManagementNegotiation of Clinical AgreementsRisk Assessment and Mitigation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Requirements KnowledgeStudy Start-Up DocumentationProposal DevelopmentRegulatory CostingBudget ManagementClinical Site Agreement ExecutionRisk Mitigation StrategiesGlobal Project ManagementPerformance FeedbackTeam Leadership

Soft Skills

CoachingMentoringRelationship BuildingCommunicationCollaboration

Industry Keywords

Pharmaceutical IndustryCRO IndustryRegulatory AffairsClinical TrialsStudy InitiationComplianceStakeholder ManagementBusiness DevelopmentProposal ContributionsProject Budgets

About the role

Key responsibilities & impact

Develop regulatory strategies based on regulatory requirements
Coordinate and oversee all study start-up deliverables from site selection through site initiation readiness
Assist senior management in securing new business through BDM participation and proposal/budget contributions
Provide strategic regulatory guidance, training, coaching, and mentoring to junior team members
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 updates on essential document collection, review, and approval status
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 study start-up and regulatory timelines
Build and maintain relationships with clients, regulatory authorities, and internal stakeholders
Monitor assigned departmental deliverables, project budgets, hours spent versus budgeted, and out-of-scope work
Develop and review regulatory sections of proposals, regulatory costing, and budgets
Provide strategic input into bids and contribute to winning new business
Coach, guide, and provide performance feedback to team members
Line manage staff members when required
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
Knowledge of regulatory requirements and country regulations
Ability to manage medium- to high-complexity global projects
Ability to develop regulatory strategies, proposals, regulatory costing, and budgets
Ability to negotiate and execute clinical site agreements, ancillary agreements, and amendments
Ability to identify, assess, and mitigate study start-up and regulatory risks

Benefits

Comp & perks

Collaborative, international team environment
Career growth opportunities
Flexible work environment
Work-life balance
Coaching, guidance, and mentoring opportunities
Opportunity to contribute to meaningful clinical research that brings safe and effective pharmaceutical treatments to patients