Manager, Study Start Up and Regulatory Affairs

🔥 15 minutes ago

🇨🇿 Czechia – 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 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 • Deliver study start-up and regulatory milestones end to end • Collect, review, 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 • Identify, assess, and mitigate risks affecting study start-up and regulatory timelines • Build and maintain relationships with clients, regulatory authorities, and internal stakeholders • Assign departmental deliverables, monitor project budgets and hours, and escalate out-of-scope work • Participate in business development meetings and contribute to proposals, regulatory costing, and budgets • Provide strategic input into bids and support new business opportunities • Coach, guide, and provide 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 with study start-up and regulatory affairs • Knowledge of regulatory requirements and country regulations • Ability to manage projects of medium to high complexity • Ability to develop regulatory strategies and contribute to proposals, budgets, and bids • Ability to provide strategic regulatory guidance, training, coaching, and mentoring • Ability to monitor project budgets, hours spent versus budgeted, and identify out-of-scope work • Ability to build relationships with clients, regulatory authorities, and internal stakeholders

🏖️ Benefits

• Collaborative, international team • Career growth opportunities • Flexible work environment • Work-life balance • Coaching, guidance, and performance feedback • Opportunity to work on meaningful clinical research supporting patients • Diverse and inclusive workplace • Supportive culture with shared ownership and trust

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