Manager, Study Start Up and Regulatory Affairs

🔥 9 minutes ago

🇵🇱 Poland – 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 agreements, ancillary agreements, and amendments • 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 • Coordinate departmental deliverables, monitor 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, mentor, and provide performance feedback to team members • May line manage staff • Perform other assigned work-related 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 activities • Knowledge of regulatory requirements and country regulations • Ability to manage clinical site agreements, ancillary agreements, amendments, and essential documents • Ability to develop regulatory strategies, proposals, regulatory costing, and budgets • Ability to identify, assess, and mitigate study start-up and regulatory risks • Ability to monitor project budgets and escalate out-of-scope work

🏖️ Benefits

• Collaborative, international team environment • Career growth opportunities • Flexible work culture • Work-life balance • Coaching, guidance, and performance feedback • Opportunity to contribute to meaningful work helping bring safe and effective pharmaceutical treatments to patients • Diverse and inclusive workplace where every voice counts

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