Job Description
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...