Manager, Study Start Up and Regulatory Affairs

🔥 9 minutes ago

🇭🇷 Croatia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

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• No salary listed.

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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 study start-up and regulatory strategy 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 for completeness and compliance, and track essential study start-up documents • Investigate incomplete, inaccurate, or missing documents • Prepare study team reports and status updates on essential document collection, review, and approval • Ensure negotiation and execution of 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 project tasks, allocated time, budgets, and hours spent versus budgeted hours; escalate out-of-scope issues • Support business development by participating in BDMs and contributing to proposals, regulatory sections, costing, and budgets • Provide strategic input into bids and support new business opportunities • Provide coaching, guidance, and performance feedback to team members • Assist senior management in securing new business • 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 of experience within the pharmaceutical or CRO industry or a regulatory body • At least 3 years of experience in a leading/project management role • Proven ability to successfully manage global projects • Experience with regulatory requirements and regulatory affairs • Experience in study start-up activities and regulatory activities • Ability to develop study start-up and regulatory strategies • Ability to manage projects of medium to high complexity • Knowledge of clinical site agreements, ancillary agreements, amendments, and country regulations • Ability to identify, assess, and mitigate risks affecting study start-up and regulatory timelines • Ability to manage project budgets and monitor hours against budgets • Ability to contribute to business development meetings, proposals, regulatory costing, and budgets

🏖️ Benefits

• Collaborative, international team environment • Career growth opportunities • Flexible work culture • Work-life balance • Coaching, guidance, and mentoring opportunities • Opportunity to contribute to meaningful work bringing safe and effective pharmaceutical treatments to patients • Collaboration with experts in clinical research, pharmacovigilance, and quality consulting

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