Manager, Study Start Up and Regulatory Affairs

🔥 2 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• 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

• 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

• 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

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