- Primarily accountable for assigned global CMC projects and provide Global Regulatory strategy. - Responsible for Preparing and filing high-quality submissions to regulatory authorities, specifically EMEA USFDA, Health Canada and other global regulatory agencies for ‘Life Cycle management’ of Pfizer Brand products.- Managing daily delivery of regulatory and strategic activities, including post-approval changes of medium/high complexity or risk projects, and ongoing compliance of commercial products in the portfolio.- Renewal of the MA - Compilation and supports the assembly of CMC information for submission to global regulatory agencies for a wide range of dosage form i.e. solid Orals, Parenteral and semisolids for Life Cycle Management of Drug products. - Responsible for quick and adequate support for the Fast Track or high priority designated projects with accuracy and to deliver in the predefined timeline.- Liaise with Pfizer Global Supply and other support functions as needed.- Goal settings and appraisal of the team.- Manage day to day work activities of the team along with the regulatory activities associated with projects assigned to the team and self.- Provides review support and guidance to the team in the impact assessment of regulatory changes, preparation of regulatory strategy and supplement/variation authoring.Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, Trackwise, etc, as appropriate.- Supports Query and/or commitment management.- Communicating with people from a variety of backgrounds/cultures and at different hierarchy levels inside & outside the company.- Remains knowledgeable about current regulations and guidance interprets to implements in the assigned projects.

Preparation of Dossier for CIS and European countries,Efficiency in CTD submissions for different type of formulations,Review of all documents pertaining to product registration,Co-ordination in query response after regulatory submission of various agencies of various countries,Review of regulatory deficiencies and preparation of response to the queries.Visit various manufacturing sites in all over India.Co-ordinate with Q.C., Q.A. & Production department for preparation of Drug Dossiers of Pharmaceutical formulations.Check artworks / printed material / packaging materialProviding regulatory updates to the organization.To conduct reference study search in libraries / internet for accumulating comparative technical data of various Formulations.Review of specifications like RM, FP & stability for regulatory compliance