Manager, Regulatory Registration and Compliance

Location: Bucharest, Bucharest, ro, Remote

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

The Manager, Regulatory Registration and Compliance is responsible for developing the strategy based on regulatory requirements and for preparing/reviewing relevant Project Plans, joint operating procedures, and/or templates. They actively assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets. This role also provides strategic regulatory guidance, training, coaching, and mentoring to junior members; may be required to line manage members of staff.

• Lead and coordinate complex regulatory projects, ensuring timely, high-quality delivery and compliance with regulatory requirements.
• Develop regulatory strategies, 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, resolve project issues, and ensure adherence to company processes and standards.
• Manage project resources, budgets, and team performance to meet agreed timelines and objectives.
• Support business development through proposal development, budgeting, and client engagements.
• Mentor and coach junior team members to support their development.
• Build and maintain strong relationships with clients, partners, and internal stakeholders.
• Monitor regulatory intelligence and communicate relevant regulatory and legislative updates.
• Support client qualification, audit and inspection readiness, and responses to findings.
• Oversee vendor qualification and performance, ensuring compliance with company standards.
• Drive process improvements and lead departmental and organizational change initiatives.

Qualifications

• University education in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology
• Experience in the pharmaceutical, CRO, or regulatory sector, including experience in a leadership or project management role
• Knowledge of Regulatory (EU) area and applicable legal and other requirements, both local and global, within pharmaceutical industry (knowledge of ICH GCP/GVP and applicable regulatory requirements)
• 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.