Chandra Sekhar Rotte

· Lead global team (4 associates) for a special project related to WHO-

Prequalification, and EU, US Extended Dossiers to Emerging markets.

· Preparation of original application dossiers for WHO, Brazil, Emerging

markets and India.

· Evaluating and preparing variation applications to Europe, WHO,

Emerging markets and India.

· Timely responding to HA queries.

· Review of Protocols, Specifications (FPP, API) which are received from

the Cross-functional team (CFTs) and providing inputs wherever

required. (inline to ICH, WHO-PQ, EMA requirements)

· Review and approval of artwork components (New submissions &

Commercial)

· Evaluating change controls (Review and provide regulatory impact

assessments for changes) via Track Wise.

· Preparation of requalification/renewal /product expansion dossiers

and tender documents for Agents Experienced in accessing the

electronic documentation-based GMP systems DCM & D2 (Uploading

and promoting)

· Engage with global business unit regulatory teams and regional

regulatory teams to ensure regulatory activities are in alignment with

business requirements.

· Submission of CEP in all applicable dossiers (WHO dossiers and

extended Emerging markets dossiers where applicable) and tracking

information from the extranet.edqm.EU/cep for a certificate of

suitability, extranet.who.int for WHO confirmation of WHO Active

pharmaceutical ingredient prequalification (CPQ) database.

· Proactively communicate CMC regulatory strategies, risks and key

issues throughout the life cycle promptly to project teams and other

stakeholders.

· Participating in the regulatory telecons for regulatory strategy.

· Preparation of product status and tracker updates i.e Pre-reg, Post

Reg. activities, marketing approvals, planning for submission as per

timelines.

· Preparing and submitting product dossiers for Brazil and Emerging

markets according to Country specific guidelines.

· Preparing and compilation of product dossiers in CTD formats for

Regulated and semi- regulated markets.

· Maintaining the product registration & Renewal status in different

countries.

· Assessing and providing regulations inputs to change controls raised

by various departments.

· Preparation of scientific justifications/declarations for regulatory

submissions.

· Legalization of registration documents from respective Embassy.

· Review and authorization of labelling artwork and their scientific

information for regulated markets.