Aditi Selokar

- Development, review and compilation of regulatory documents resulting in the
submission of high-quality new dossier for agency filing/customer dossier audit,
dossier query response (agency/customer) and variation filing in eCTD format as per
regulatory guideline requirement (EMA, CMDH, ICH, MHRA) for Europe and UK market.
- Preparation, compilation and submission of MA renewals in Europe and UK.
- Preparation and reviewing SmPC, package leaflet and artworks as per QRD guideline.
- Hands on experience on the software's like Pharmaready, Lorenz eValidator,
Trackwise, DMS and submission portals-CESP & UK MHRA portal.
- Artwork review and development (Carton, Foil & Package Leaflet) registered product and commercial product launch.
- Calculation and review of fees for initial applications, renewal applications and
different type of variations.
- Product life cycle management of registered and commercial products.
- Provided summaries of complex communication and follow-up resulting in proper and timely regulatory action.
- Reviewed change controls on Trackwise and initiated change control for commercial
artworks.
- Reviewing all CMC documents like batch conversion form, PDR, BMR, BPR, AMV, PVR,
Stability data, Specifications/STP, etc. as per ICH and EMA requirements and identifying & rectifying errors in the documents for the submission.

I, worked as a Junior Officer in Regulatory Affairs (Europe & UK market) with Macleods Pharmaceuticals Limited for the last 2.2 years.

Bachelor of pharmacy 

Master of pharmacy in pharmaceutics