Manager, Study Start Up and Regulatory Affairs

ERGOMED

. Develop regulatory strategies based on regulatory requirements .

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

Core Competencies

Role fit

Core Competencies

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

Highest-signal resume keywords

Regulatory Strategy DevelopmentStudy Start-Up ManagementProject ManagementClinical Site Agreement NegotiationRisk Assessment and Mitigation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory RequirementsStudy Start-Up ActivitiesProject Budget MonitoringDocument Collection and ReviewGlobal Project Management

Soft Skills

Coaching and MentoringRelationship BuildingCommunication Skills

Industry Keywords

Pharmaceutical IndustryCRO IndustryClinical TrialsStudy DocumentsBusiness 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
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 updates on document collection, review, and approval status
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
Monitor departmental deliverables, project budgets, and hours against budget
Participate in business development meetings and develop or review regulatory proposal sections
Provide coaching, guidance, training, mentoring, and performance feedback to junior team members
Line manage staff 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 of experience 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 regulatory requirements and study start-up activities
Ability to manage projects of medium to high complexity
Ability to develop regulatory strategies and oversee study start-up deliverables
Ability to manage clinical site agreements, ancillary agreements, and amendments
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 provide strategic input into bids, proposals, regulatory costing, and budgets

Benefits

Comp & perks

Collaborative, international team environment
Flexible work-life balance
Career growth opportunities
Coaching, guidance, and mentoring opportunities
Opportunity to work on meaningful rare disease and oncology clinical research
Opportunity to contribute to new business proposals and business development
Diverse and inclusive workplace where every voice counts