Senior Specialist, Regulatory Registration and Compliance

Company Description

Medicine moves forward here. So will you. 

At PrimeVigilance, patient safety is not one part of the job. It is why we exist. 

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on. 

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from. 

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

Job Description

Key Responsibilities:

• 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.

Qualifications

• 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

Additional Information

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. 

We look forward to welcoming your application.