Head Regulatory Affairs, strategizing and supporting global regulatory filings across various regions on New Development Programs and Life Cycle Management of Complex Parenteral Formulations.

To manage/facilitate global regulatory affairs activities and Strategic Consulting, including business continutiy plan & regulatory strategy development.

Reg CMC - Global Regulatory Manager

To articulate regulatory strategy for DMF changes for Business Continuity.To articulate regulatory strategy for Post approval changes.To facilitated and formalize responses to regulatory queries.To facilitate/formalize regulatory process optimization.To conduct regulatory audits of API, Formulation, RnD and CRO facility.To review and approve Labelling relevant information.To assess, evaluate and approve incidents, deviations and change controls.

Started career with strides in January 2006, when Strides was in initial stages of filing ANDA's to FDA.Key Accomplishments:First product to be commercialized from Strides to USA was filed by me and was one of the complex molecules where in there very limited players in USA.Designed and formalized Type V DMF submission to US FDA.Obtained 13 US FDA approvals in year 2008 for parenteral products.Profile:To formulate regulatory strategy and tactics for all appropriate regulatory submissions (e.g., ANDA’s, dossiers, amendments, and supplements) for international, and/or contract projects. primary regulatory liaison representative on project teams, providing team members with regulatory input for post-approval changes requiring regulatory submissions, for international regulatory applicationsDirectly Co-ordinate/Interact with various customers on regulatory front to finalize/firm up regulatory strategies and to also to resolve any regulatory issuesTo Review and analyze regulatory and related publications to assure compliance and anticipate future regulatory actions both internally and externally (Manufacturing records, Process validation protocols, Specifications, Development reports.)Provides project management support to Labeling Specialist in development and review of draft and final product labeling.Guiding and providing Regulatory advise to Formulation development for selection of RLD and validation approachPrimary Outcomes:On time submission and approval of applications, amendments, and supplements. Maintain approved applications in compliance with appropriate statutes, regulations, and guidance’s. Provides sound regulatory advice/guidance to business, research, and operations professional staff. Provides training and coaching to junior RA professional staff members. .

Regulatory Affairs and Regulatory compliance formulations and API from Lupin Mandideep facility catering Global filing requirements.Job Profile:Mainly worked on ANDA’S (sterile and non sterile formulations), DMF’S (sterile and non sterile) and supported registrations in Europe.To articulate regulatory strategy for formalization of supplemental filings and also to facilitate process development team for improvsations in API processes.Reviewing of BPR’S, Validation protocols, Stability protocols, Specifications.Guiding R&D in designing specifications and stability protocols prior to Exhibit batches initiation regarding various regulatory concerns.Evaluation & approval of change controls keeping in consideration of various regulatory commitments.Review & approval of packing materials.Supporting corporate regulatory for their requirements on: Standards, samples, packing materials, Specs, STP’s , COA’S, stability data, & Legal documents (GMP certificate, FSC & Product license), & Supporting them to address queries received from Various authorities.Handled and timely responded to Queries of various customers & Regulatory authorities in Co ordination with QA – QC team.Updating QC/QA & Operations with respect to Various Regulatory commitments.

Started Career as Trainee in Sterile Bilogical manufacturing facility, handling Operations as well as Quality assurance.Job Profile:Mainly associated with Manufacturing / IPQA activities of Sterile Preparations (i.e. Hormones, Vaccines and regular sterile preparations)Preparation & execution of departmental SOP’S. Training the workers & chemists for proper behaviour & educate them about the product.Coordinated with Formulation Development for new product launch & assisting them for execution of developmental batches. Monitoring & supervising various production related activities such as vial washing, rubber stopper washing, aseptic filling, Lyophilization operation, cap sealing, visual inspection, labeling and Packaging..Hands on experience in Aseptic manufacturing of bulk & as well as aseptic filtration & filling, Lyophilization.Hands on experience in manufacturing iof prefilled syringe products. Handled various critical instruments associated with production such as Tunnel, DHS Oven, Vial Washing, Lyophilizer, Prefill Syringe equipment and etc.Maintenance & upkeepment of production area as per CGMP & FDA requirement.Actively involved in validation of various critical instruments along with Engineering & Validation personnel.Successfully commissioned pharmaceutical freeze drier (make Usifroid model CL 410).Facilitated various GMP Audits.