Senior Specialist, Regulatory Registration and Compliance

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Prepare and manage marketing authorization (MA) submissions, including the preparation of local administrative documents, quality control (QC), and compilation. • Provide ad hoc regulatory advice on submission packages in the post-authorization stage of the medicinal product lifecycle. • Review and provide linguistic input for local Product Information and Mock-ups. • Serve as the primary contact point for regulatory affairs (RA) matters with national competent authorities (NCAs) and/or clients. • Involvement in project management of the network of local contact persons for Regulatory affairs. • Collect, process, and manage regulatory intelligence to keep the organization informed of key updates and changes. • Propose marketing authorization strategies tailored to client needs. • Act as a deputy for the line manager when required, ensuring seamless continuity in leadership and operations.

🎯 Requirements

• University education in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology • Previous industry experience is essential • Knowledge of Regulatory (EU) area and applicable legal and other requirements (both local and global) within pharmaceutical industry • Excellent organizational skills with the ability to manage multiple projects and deadlines. • A collaborative mindset, coupled with excellent communication skills to liaise with clients and regulatory bodies effectively. • Advanced knowledge of English (both written and verbal) • Experience with centralised procedures advantageous • Experience with regulatory databases and dossier management software advantageous

🏖️ Benefits

• When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. • You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting. • We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. • Quality: we hold ourselves to the standard patients deserve. • Integrity and trust: we do the right thing, especially when it is hard. • Drive and passion: we care about the outcome, because someone is waiting on it. • Agility and responsiveness: we move quickly, because patients cannot wait. • Belonging: everyone is welcome, and every voice counts. • Collaborative partnerships: we go further by going together.