Sachin Chede
Manager Regulatory Affairs (New Products) at ADVANZ PHARMA
- Role
- Manager Regulatory Affairs (New Products) at ADVANZ PHARMA
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Sachin Chede
Masters in Pharmacy (Quality Assurance Technique) with research specialization in…
Experience
Manager Regulatory Affairs (New Products)
Nov 2021 — Present · Andheri (Mumbai), IN
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.
Education
STCOP Shirur
Bachelor of Pharmacy (B.Pharm.)
2003 — 2007
Maharashtra Institute of Technology
Master in Pharmacy (Quality Assurance)
2007 — 2009
Saraswati Vidhyaprasark Trust's Rabodi (Thane)
SYJC Science
2000 — 2003
Institute of Pharmaceutical Management.
Post Graduate Diploma in Drug Regulatory Affairs (Formulation)
2010 — 2011
Skills
- Validation
- Ectd
- Regulatory Affairs
- Pharmaceutics
- Regulatory Requirements
- Pharmaceutical Industry
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