Manager, Regulatory and PV Delivery

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🌐 New Zealand, Romania – Remote

🇳🇿 New Zealand – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 strategy based on regulatory requirements • Drive regulatory and pharmacovigilance deliverables based on established PV and regulatory plans • Assist senior management in securing new business through BDM participation and proposal/budget contributions • Provide strategic regulatory guidance, training, coaching and mentoring to junior staff • Lead and represent complex projects and deliverables • Coordinate, manage and execute regulatory tasks while driving teams to meet targets and procedures • Provide strategic input to internal and external customers • Identify and address risks through preventive measures • Resolve performance issues and delivery failures • Advise clients on complex queries and changes in local regulations and guidance • Monitor project tasks, budgets and hours against budget; identify and escalate out-of-scope work • Develop and review regulatory sections of proposals, regulatory costing and budgets • Prepare client invoices and review or approve vendor project invoices • Support client qualification activities • Ensure audit readiness and coordinate departmental participation in audits and inspections • Prepare or contribute to the Regulatory Newsletter and update the regulatory database • Collect, quality-control review and disseminate regulatory intelligence • Support interpretation and impact analysis of legislation • Foster professional relationships with local and international contacts • Drive department and company initiatives and manage change implementation

🎯 Requirements

• Minimum 3 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 • Expert knowledge of ICH GCP and/or GVP • Expert knowledge of relevant legislation and local requirements for territories of competency

🏖️ Benefits

• Remote work availability • Flexible work environment • Growth opportunities • Collaborative team culture • Training, coaching and mentoring opportunities • Global and international work exposure • Opportunity to contribute to meaningful patient-safety work