Experienced in Regulatory filings (Regulated Market)
Experience in India /ROW markets in Regulatory would be an added advantage
Experienced in Regulatory filings for Regulated Market- Generic applications, Query responses and variation applications.
Experience in India and / ROW market will be an added advantage Submission of Generic applications to regulated markets e.g. US, EU, Canada. UK etc.
Answering queries from Agency related to Generic/ variation applications Variation applications (Minor/ Major) Communication with the Agencies for any filing related matters
Co-ordination with cross functional teams to get the required information Support to regulatory related commercial activities
Have basic knowledge related to working on software and working on Agency portals (Regulatory markets and / Sugam - India)