Manager, Regulatory and PV Delivery

Job not on LinkedIn

🔥 0 minutes ago

🌐 New Zealand, Serbia – Remote

🇳🇿 New Zealand – Remote 🇷🇸 Serbia – 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.

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 strategy based on regulatory requirements • Drive regulatory and pharmacovigilance deliverables based on established plans • Lead and represent high-complexity 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 • Communicate project tasks and time allocations to team members • Monitor project budgets and escalate out-of-scope work • Participate in business development meetings and develop/review regulatory proposal sections, costings, and budgets • Prepare client invoices and review/approve vendor project invoices • Provide training, coaching, and mentoring to junior staff • Support client qualification activities • Ensure audit readiness and coordinate departmental audit/inspection representation • Prepare or contribute to the Regulatory Newsletter and update the regulatory database • Collect, quality-control review, and disseminate regulatory intelligence • Support legislation interpretation and impact analysis • Foster professional relationships with local and international contacts • Drive department/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 • Ability to provide strategic regulatory guidance • Ability to manage complex regulatory and pharmacovigilance deliverables • Ability to monitor project budgets, hours spent versus budgeted, and identify/escalate out-of-scope work • Ability to support audits, inspections, client qualification activities, and regulatory intelligence activities

🏖️ Benefits

• Remote work option • Flexible work environment • Growth opportunities • Collaborative team environment • Training, coaching and mentoring opportunities • Professional development through participation in company initiatives • Opportunity to contribute to patient safety and global pharmaceutical projects