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.
• 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.

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.
• 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.

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 &.
• 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.
• 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.
• 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.

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.

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.
• 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.

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.
• 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.

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