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 • RomaniaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in developing regulatory strategies and managing study start-up processes within the pharmaceutical or CRO industry. Proven ability to lead global projects, manage clinical site agreements, and contribute to business development efforts.

Highest-signal resume keywords

Regulatory Strategy DevelopmentStudy Start-Up ManagementProject ManagementRisk Assessment and MitigationClinical Site Agreement Management

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

Regulatory Requirements KnowledgeStudy Document ManagementBudget MonitoringProposal DevelopmentGlobal Project Management

Soft Skills

Relationship BuildingCoaching and GuidancePerformance Feedback

Industry Keywords

Pharmaceutical IndustryCRO IndustryClinical TrialsStudy Start-Up DeliverablesBusiness Development

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, ancillary, and amended agreements
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
Assign departmental tasks, monitor budgets and hours, and escalate out-of-scope work
Support business development through BDM participation, proposals, regulatory costing, and budgets
Provide coaching, guidance, and 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 developing regulatory strategies and coordinating study start-up deliverables
Knowledge of regulatory requirements and country regulations
Ability to manage clinical site agreements, ancillary agreements, amendments, and essential study documents
Ability to identify, assess, and mitigate study start-up and regulatory risks
Ability to monitor project budgets and escalate out-of-scope work
Ability to contribute to business development meetings, proposals, regulatory costing, and budgets

Benefits

Comp & perks

Collaborative, international team environment
Flexible work culture
Work-life balance
Career growth opportunities
Coaching, guidance, and mentoring
Opportunity to contribute to meaningful clinical research that brings treatments to patients
Supportive workplace where everyone is welcome and every voice counts