Eugia Pharma - Regulatory Affairs Role - Canada Reference Product

Title : Regulatory Affairs - Canada

Location : Hyderabad ( Bachupally )

Job Role:

- Preparation and update Auros Product Monograph by referencing Canadian Reference Product (CRP) Monograph and also following with PM guidance / HC master template.

- Preparation of Auro's Label by referencing CRP label and in line with the HC labeling guidance.

- Preparation and review of Module 1 and Module 5 documents for ANDS, SANDS labeling and Level III Submissions in timely manner.

- Collaborate with the RA Canada team on safety-related submissions such as Advisement Letters and Level III changes.

- Co-Ordinating with artworks preparations team for development of label / cartons / package insert for ANDS / SANDS labeling submission purpose.