Manager, Regulatory and PV Delivery

Job not on LinkedIn

🔥 1 minute ago

🌐 New Zealand, Croatia – Remote

🇳🇿 New Zealand – Remote 🇭🇷 Croatia – 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 regulatory strategy based on regulatory requirements • Drive regulatory and pharmacovigilance deliverables according to established plans • Lead and represent complex projects and deliverables • Coordinate and manage regulatory tasks and drive teams to meet targets and procedures • Provide strategic input to internal and external customers • Identify and mitigate risks and resolve performance or delivery issues • Advise clients on complex queries and changes in local regulations and guidance • Monitor project budgets, hours spent, and out-of-scope work • Participate in business development meetings and prepare proposals, regulatory costing, and budgets • Prepare client invoices and review or approve vendor project invoices • Provide training, coaching, and mentoring to junior staff • Support client qualification activities and audit readiness • Prepare regulatory newsletters and update regulatory databases • Collect, quality-check, and disseminate regulatory intelligence • Support interpretation and impact analysis of legislation • Foster professional relationships with internal and external contacts • Drive department and company initiatives and manage change implementation

🎯 Requirements

• Minimum 3 years within pharmaceutical or CRO industry or 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 option • Flexible work environment • Growth opportunities • Collaborative and supportive team culture • Training, coaching and mentoring opportunities • Global exposure and purpose-driven work • Belonging-focused workplace culture