Manager, Regulatory Registration and Compliance

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🔥 0 minutes ago

🌐 Serbia, Bulgaria – Remote

🇷🇸 Serbia – Remote 🇧🇬 Bulgaria – 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.

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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 strategies based on regulatory requirements • Prepare and review project plans, joint operating procedures, and templates • Assist senior management with new business development through BDM participation and proposal/budget contributions • Provide strategic regulatory guidance, training, coaching, and mentoring to junior members • Line manage staff members when required • Lead and coordinate complex regulatory projects, ensuring timely, high-quality delivery and compliance • Manage project setup activities and provide expert guidance to internal and external stakeholders • Prepare, review, and oversee regulatory submissions and documentation for FDA, EMA, and other health authorities • Identify and mitigate risks and resolve project issues • Ensure adherence to company processes and standards • Manage project resources, budgets, and team performance • Support proposal development, budgeting, and client engagements • Build and maintain relationships with clients, partners, and internal stakeholders • Monitor regulatory intelligence and communicate regulatory and legislative updates • Support client qualification, audit and inspection readiness, and responses to findings • Oversee vendor qualification and performance • Drive process improvements and lead departmental and organizational change initiatives

🎯 Requirements

• University education in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology • Experience in the pharmaceutical, CRO, or regulatory sector • Experience in a leadership or project management role • Knowledge of the EU Regulatory area and applicable legal and other requirements, both local and global, within the pharmaceutical industry • Knowledge of ICH GCP/GVP and applicable regulatory requirements • Excellent organizational skills with the ability to manage multiple projects and deadlines • Collaborative mindset and excellent communication skills for liaising with clients and regulatory bodies • Advanced knowledge of English, both written and verbal • Experience with centralised procedures advantageous • Experience with regulatory databases and dossier management software advantageous

🏖️ Benefits

• Remote work options • Flexible work environment • Growth and development opportunities • Training, coaching, and mentoring • Collaborative and supportive team culture • Opportunity to contribute to global patient safety and pharmaceutical treatment • Diverse and inclusive workplace • Professional development through exposure to clinical research, pharmacovigilance, and quality consulting