Your Role

You will be responsible for the regulatory management of a diverse pharmaceutical portfolio (OTC & Rx, generics, multiple dosage forms), covering national, MRP and DCP procedures (no centralized procedures).

Key responsibilities include:

• Defining and advising on regulatory strategy for new and existing products


• Managing regulatory submissions (new MAs, variations, renewals) in eCTD format


• Handling publishing activities and responses to Health Authorities


• Providing scientific and technical regulatory expertise, including Module 3 compliance


• Monitoring regulatory changes and advising stakeholders accordingly


• Acting as an RA expert within cross‑functional project teams

No people management is required in th...