Strategic Regulatory Lead: Submissions & Compliance

Ergomed; Województwo mazowieckie; On-site; PLN 180,000 - 240,000; Full time

Job summary

Ergomed is seeking a Manager, Regulatory Registration and Compliance to lead regulatory projects and shape strategies across FDA, EMA, and other authorities. You will mentor juniors, manage budgets, and liaise with clients to ensure compliant submissions.

The role requires leadership, EU regulatory knowledge, and excellent English communication, with a focus on delivering high-quality results in a fast-paced environment. Join a team committed to patient safety and scientific excellence.

Qualifications

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

Responsibilities

• Lead and coordinate complex regulatory projects to ensure timely, high-quality delivery and compliance.
• Develop regulatory strategies and manage project setup activities.
• Prepare, review, and oversee regulatory submissions for FDA, EMA and other health authorities.
• Identify and mitigate risks and ensure adherence to company processes and standards.
• Manage project resources, budgets, and team performance to meet timelines.
• Support business development through proposals, budgeting, and client engagements.
• Mentor and coach junior team members to support development.
• Build and maintain strong relationships with clients, partners and internal stakeholders.
• Monitor regulatory intelligence and communicate relevant updates.
• Support client qualification, audit readiness, and responses to findings.
• Oversee vendor qualification and performance.

Skills

Regulatory knowledge

Leadership experience

Project management

Professional English

Communication skills

Regulatory intelligence

Education

Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology degree

Tools

Regulatory databases

Dossier management software

Job description

Ergomed is seeking a Manager, Regulatory Registration and Compliance to lead regulatory projects and shape strategies across FDA, EMA, and other authorities. You will mentor juniors, manage budgets, and liaise with clients to ensure compliant submissions.

The role requires leadership, EU regulatory knowledge, and excellent English communication, with a focus on delivering high-quality results in a fast-paced environment. Join a team committed to patient safety and scientific excellence.