Sachin Chede Email & Phone Number

Andheri (Mumbai), India

•Regulatory management of several New pipeline products within Europe market in support of ADVANZ PHARMA’s strategic initiatives and objectives.•Prepare Regulatory submission strategies, conduct dossier due diligence and identify timelines for all new projects that have been identified by the BD&L team and which are to be reviewed and approved by senior management.•Work with external partners throughout the project lifecycle to ensure all parties have all the necessary elements in place to successfully secure timely Marketing Authorizations.•Timely preparation and submission of regulatory applications for new pipeline products, including in-licensing, product developments and registering existing products into new markets.• Direct communication with regulatory authorities to facilitate productive dialogue on all new product submissions and other relevant issues.•Escalate risks / issues appropriately to remove barriers to success or advise of delays and other changes which may impact the regulatory approval timeline.•Propose improvements or alternative approaches to obtain improved project deliverables.

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

•Responsible for leading a team of 6 Regulatory Associates with focus on compilation & submission of New Registration dossier as well as maintenance of Life Cycle Management of marketed products within the Europe market.•Accountable to manage team resources to achieve completion of timely submissions, right first time, high quality applications; complete and accurate responses to Requests for Information (RFI) and effective communication of submissions and approvals.•To provide adequate regulatory inputs right from initial development stage of new developmental projects for in-house development as well as the products being developed at CROs.•Regulatory oversight and due diligence review for third-party dossiers as well as in-house developed products. To perform Online Audit/ Desktop Audit of third party dossier for In-licensing business.•Running MR/DC & National procedures in close contact with the European Health Authorities for Bristol Laboratories Limited. Manage National Phase Submissions (Post-DCP /Post-MRP) of registration dossier.•Making strategies & handle execution of the Quality variations based on the business cases like New Launches, Regular Commercials & Planned MRPs/ RUPs.•Handled numerous Site Transfer Projects of Bristol Labs, in collaboration with other cross-functional teams (Tech transfer, F&D, ADL) & CMOs (Contract Manufacturing Organizations). In parallel perform the variation submission activities for site transfer projects.•Provide support and training to ensure the balanced growth of teams and the development of the department as whole. Conduct regulatory knowledge sharing sessions within a team as and when required.•Close cooperation with Business Development and Supply Chain Management team. Ensuring compliance and continuity of product supply and support to the Commercial team(s) in achieving the set objective.

Mumbai, Maharashtra, India

•Responsible for leading a team of 10 Regulatory Associates with focus on compilation & submission of New Registration as well as Life Cycle Management of marketed products within the Europe, GCC & MENA (Middle East & North Africa) markets; with respect to all the business formats of Apotex (Own-registration, Out-licensing as well as In-licensing). •Planning & prioritization of regulatory activities (New Registration & PLCM) for Europe, GCC & MENA (Middle East & North Africa) markets, in co-ordination with stakeholders located across multiple time zones like Leiden (Netherland), Toronto (Canada) & Riyadh (Saudi Arab) as well as in collaboration with the development sites in Toronto (Canada) and Bangalore (India). •Regulatory oversight and due diligence reviews for third-parties dossiers as well as for dossiers in-house developed products.•To support all required processes at various stages leading up to right first time PLCM submissions resulting in timely closure of the procedure and national approvals to ensure product supply continuity and quality for Europe. •Making strategies of the EU variations based on the business cases like New Launches, Regular Commercials & Planned MRPs/ RUPs. •Running MR/DC procedures in close contact with the European Health Authorities.•Close cooperation with Portfolio, Supply Chain, and Business Development & Global Project Management of Apotex. •Provide support and training to ensure the balanced growth of teams and the development of the department as whole. Conduct regulatory knowledge sharing sessions within a team as and when required.

Mumbai, Maharashtra, India

•Responsible for mentoring a team of regulatory associates for New Registration as well as Post Approval Life Cycle•Management (Quality/ Safety variations& Renewal applications) of the marketing authorizations for Europe market.•Successfully executed the role of “Subject Matter Expert for CMC Review” within a team, to conduct the peer review of• New registration dossiers as well as PLCM dossiers before final dispatch to EU health authorities; with respect to all thenbusiness formats of Apotex (Own-registration, Out-licensing as well as In-licensing).• Independently responsible to handle the preparation, compilation, review and submission of high quality regulatory dossiers to•Health Authorities, in support of new marketing authorization applications and the maintenance of existing licenses via National, MRP/ DCP and Centralized Procedures.•To liaise & make frequent interactions with Competent Health Authorities and if required other applicable departments within the organization to discuss and provide right solutions to regulatory issues or problems.•To perform Online Audit/ Desktop Audit of third party dossier for In-licensing business, performed due diligence for more than Six third party dossiers for Apotex.•To prepare/ maintain product data sheet or product offer sheets as required for out-licensing business for Europe Market.•To maintain XEVMPD - Eudravigilance Database to meet EMA compliance, wherever applicable.•Well versed with handling e-CTD software like Lorenz DocuBridge, EURS validator, Lorenze validator & BfArM Validator.•To update Regulatory Information Management System (RIMS/ Track-Wise) and distribution of notifications to Business.

Mumbai (Vikhroli)

Responsibilities handled with respect to Post Approval Life Cycle Management (PLCM) for PAN Europe Market:•Accountable for handling the PLCM (Module I to V) of the marketing authorizations for the PAN Europe market; chiefly accountable for the CMC variations for own registration business as well as for the customer-based business in PAN Europe market.•Compilation, review and filling of CMC variation application into ICH and country specific formats (CTD/NeeS/eCTD) for assigned projects for PAN Europe Market.•Highly proficient in handling the National Portals of Health Authorities of EU member states particularly UK (MHRA) & Portugal (INFARMED) for submission of National variation application. •Proficient in preparation and delivery of e-submissions of MR Variation applications via Common European Submission Platform (CESP) for various health authorities as applicable; for PAN European Market.•Active involvement in the making the strategies of the EU variations based on the business cases like New Launches, Regular Commercials & Planned MRPs/ RUPs.•Maintenance of variation submission tracking and approval database to enable timely and compliant implantation of license updates. Responsibilities handed with respect to product registration in PAN Europe Market:•Compilation, collation & submission of registration dossier (Module I to V) as per EU requirements for Generic Product application into ICH and country specific formats (CTD/NeeS/eCTD) for own registration as well as for the customer-based business in PAN Europe market via key registration procedures i.e. DCPs, MRPs & National Procedures.•Handling receipt and responding to queries raised by Regulatory authorities and Customer on time.•Execute the weekly and monthly plans to ensure annual targets are achieved for both submissions and approvals.•Preparing and sending out project progress reports and raising early alarms on issues that might delay approvals

Thane (West), Maharashtra, India.

•Worked in numerous development trials of various types of Pharmaceutical Dosage forms•Performed various formulation operations of the development trials of solid & liquid dosage forms like Sifting, Granulation, Milling, Lubrication, Compression, Coating operations, Drug layering & coating of pellets and Extrusion- spheronization.•Worked on various instruments like Rapid mixer granulator, Tablet compression machine, Conventional pan coater, Perforated pan coater, Fluid bed dryer, Wruster coater, Roto processor (Tangential spray coater)•Actively involved in compilation work and updating day to day activities into product development records.•Also assisted team members in executing scale-up batches.•Worked on development of various dosage forms:-Development of Coated tablets (Conventional tablets, film coated tablets, Enteric coated tablets & modified release tablets.-Development of Pellets (Controlled release pellets & Enteric coated pellets)-Development of Extrudates.-Dry suspension for reconstitution.-Taste masked pellets for oral suspensions.-Oral solutions (Multivitamin syrup)

Post Graduate Diploma In Drug Regulatory Affairs (Formulation), Pharmaceutical Sciences, A Grade

Master In Pharmacy (Quality Assurance), Pharmaceutical Sciences, First Class

Bachelor Of Pharmacy (B.Pharm.), Pharmaceutical Sciences, First Class

Syjc Science, Science, First Class