Manager, Regulatory and PV Delivery

Job not on LinkedIn

🔥 1 minute ago

🌐 New Zealand, United Kingdom – Remote

🇳🇿 New Zealand – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 16%

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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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, manage and execute regulatory tasks • Drive teams to meet agreed targets and comply with procedures, trackers and templates • Provide strategic input to internal and external customers • Identify and mitigate risks through preventive measures • Resolve performance issues and delivery failures • 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 • Ensure audit readiness and coordinate departmental audit participation and responses • 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 internal and external contacts globally • 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 available • Kindness, flexibility, growth and belonging culture • Training, coaching and mentoring opportunities • Collaborative team environment • Global reach and professional growth opportunities