Mandatory technical skill and experience
1. Atleast 8 years in Regulatory Affairs
2. Hands on experience in Europe & Australia region.
3. Experience in other regions like, US, South Africa, GCC and ROW is considered as add on experience
4. Exposure to direct filing with the regulatory authorities for registration, variation and maintenance of product dossier
5. Major experience in solid dosage forms and liquid orals
6. e-CTD software management
7. End to end registration from reference product assessment till marketing authorization approval
8. Able to work independently where required and cooperatively in team setting
Cross functional interaction
1. Excellent verbal and written communication skills
2. Able to effectively communicate with internal and external customers
3. Interaction with development team, analytical team, clinical team and providing guidance where required through the development
4. Effective communication with the cross functions for the input document for dossier compilation
5. Understanding and conveying of RFI to the cross functions and timely closure of the RFI
6. Must be able to meet deadline with a positive attitude and atmosphere
Managerial skills
1. Good relationship with the team, keeping the organizational goal as the primary motive
2. Able adopt to the culture and norms of the organization and enforce the same to the team
3. Training the team in technical and other soft skills as required