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 • SerbiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy development and project management within the pharmaceutical or CRO industry, with a strong focus on study start-up processes and compliance. Proven ability to lead teams, manage complex projects, and maintain stakeholder relationships while ensuring timely delivery of regulatory milestones.

Highest-signal resume keywords

Regulatory Strategy DevelopmentProject ManagementStudy Start-Up CoordinationClient Relationship ManagementTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory GuidanceStudy Start-Up DeliverablesDocument Review and ComplianceRisk Assessment and MitigationClinical Site Agreement NegotiationBudget ManagementProposal DevelopmentPerformance FeedbackTraining and CoachingGlobal Project Management

Soft Skills

CommunicationMentoringCollaborationProblem-SolvingNegotiation

Industry Keywords

Pharmaceutical IndustryCRO IndustryRegulatory BodyStudy Initiation ReadinessBusiness DevelopmentCompliance StandardsClinical TrialsStakeholder EngagementProject BudgetsLife Sciences

About the role

Key responsibilities & impact

Develop regulatory strategy and coordinate and oversee study start-up deliverables from site selection through site initiation readiness
Assist senior management in securing new business by participating in BDMs and contributing to proposals and budgets
Provide strategic regulatory guidance, training, coaching, and mentoring to junior members
Lead study start-up and regulatory activities for assigned medium- to high-complexity projects
Manage end-to-end delivery of 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
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
Maintain relationships with clients, regulatory authorities, and internal stakeholders
Monitor assigned team tasks, project budgets, hours spent versus budgeted, and escalate out-of-scope work
Develop and review regulatory proposal sections, regulatory costing, and budgets
Provide strategic input into bids and contribute to winning new business
Provide coaching, guidance, and performance feedback to team members
Perform other work-related duties as assigned

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

Benefits

Comp & perks

Work-life balance
Collaborative, international team
Career growth opportunities
Trusted to take ownership early
Passionate and collaborative team of experts
Diverse and inclusive workplace where every voice counts