Manager Development

Name: SACHIN S. SHELKE

Address: ARK Towers, Flat No. 727, ‘D’ Block, Mayuri Nagar, Miyapur Hyderabad-500049

Mobile : +91-958-***-****

Email: **************@*****.**.** / ******.*******@*****.***

SUMMARY

Fifteen years documented success record and recognized expertise in ‘Analytical Research and Development’ at Innovator and Generic companies.

Gaining vital experience within Pharmaceutical Regulatory Affairs now. Demonstrating exceptional analysis, leading projects, strategic problem solving and good communication ability.

Diligent & result-oriented professional, with more than 15 years of experience across pharmaceutical industry; with exceptional academic credentials, currently spearheading as Manager Regulatory CMC in one of the world leading brand Novartis Pharmaceuticals Ltd.

All-round competencies in Pharmaceutical Research domain including a wide range of all fine aspects covering Regulatory submissions in US, EU and Row countries. Handling HAQ’s

Responsible for mentoring and managing a team for regulatory 505 (j) Para 1-IV, 505 b(2)submissions (Compilation, review of CMC part-Module 1-3 inclusive of labelling as per eCTD and Evaluation of BE study reports for adequacy), time based query management, timely approval and Lifecycle management of products amendments, Prior Approval Supplements, annual reports, PADER submissions, USDA Letters, Controlled correspondences, Bio correspondences, Suitability petitions, Citizen Petitions, Reposition of regulatory database and compliance to procedures.

Review and Evaluation of QA and QC documents (Product development reports as per QbD requirements, process validation protocols/Reports, Exhibit, master, intended batch manufacturing and packaging records, specifications, test procedures, stability data protocols/reports, etc.)

Expertise in Analytical Method development, Compatibility Studies, Impurity Profiling, Dissolution development, Documentation including preparation of protocols and standard operating procedures, Data Review. Expertise in managing third parties (Contract Research Organizations) for execution of outsourced projects Good knowledge across various Health Regulatory authority Guidelines.

Ability to conceptualize the processing for Project management & sophisticated quality assurance measures in compliance to specified standards while performing root-cause analysis to prevent any reoccurrences & defects.

Possessing the confidence and more enthusiasm to acquire necessary skills in new areas and the self-motivation to work reliably with independence or as a respected team member, highly self-motivated with the ability and focus to follow regulatory compliance and pursue thoroughness and accuracy in preparation.

EXPERIENCE

Novartis Pharmaceutical, INDIA Manager - Regulatory CMC October 2015 – Till date

Features:

Hand on experience in negotiating development data and filling strategies with the FDA’s in Pre-IND, Pre NDA, and general meetings.

Experience with various immediate and modified release dosage forms e.g. Solid orals, Suspensions, Solutions and Sterile formulations.

Filled NDA’s, IND’s, multiple Amendments / Supplement’s and Annual Reports.

Managing post approval lifecycles for Pharmaceutical products.

Compilation, review and submission of various CMC activities (creation of module 2.3, module 3, quality variations, renewals, RFI, query responses etc.) to the health authorities in regulated market.

Co-ordinate with various departments of stake holders (regional team, production, quality assurance, packaging, etc.) for documents requirement and review it for submission.

Review of all technical documents received from stake holders (from R & D, production, quality control, quality assurance, packaging, etc.).

Checking compliance of SOPs is followed properly, creating and reviewing of new SOP’s,

Management, training and development of all regulatory personnel within team.

Provide strategic advice on relevant regulatory issues.

Maintaining and developing awareness of current regulatory legislation and guidelines.

Prioritising, planning and monitoring allocated projects against defined timelines.

Novartis Pharmaceutical, INDIA Principal Scientist- Analytical R & D Sept 2010 – Sept 2015

Features:

Worked as a Principal Scientist in Analytical Development Laboratory for New Chemical Entities (NCE’s) molecules.

Participated in project meetings and focused on analytical activities with cross site and cross functional department for project deliverables.

Responsible for conducting project meeting through TC’s and VC’s across the sub-continents (US, Switzerland, and Germany) for project follow-ups and activity updates.

Responsible for the quality and output of projects outsourced to third party (CRO’s) across the sub-continents.

Responsible for troubleshooting and project related issues in the laboratories within Novartis as well as for the projects running with third parties.

Working with global partners (US and EU) with excellent communication skills and understanding of project deliverables including DP as well as DS.

Development of analytical methods for finished drug products for regulated markets, Analytical method transfer. Validation of analytical method as per ICH as well as internal guidelines including preparation of Validation protocols, planning of laboratory activities, trouble shooting during validation and drafting of final report.

As a project responsible analytical expert, ensures alignment with stakeholders during early to late development phases.

Expertise in forced degradation studies, impurity profiling, excipient compatibility studies, QbD and DoE testing’s including Bergum approach for lab scale as well as Pilot phase DOE

Interaction with Analytical development, Formulation development, PHAD sub team, Regulatory affairs, Quality Control and DSM to ensure smooth deliverables and demand of needs across all line functions.

Planning stability (Technical, Clinical and Registration) for of drug products targeted for regulated market as per ICH guidelines as well as Novartis internal guidelines.

Review of analytical raw data with goal of producing First Time Right document to enhance quality.

Review of analytical raw data.

Key contributor during all internal as well as health authority audits. Faced USFDA auditors, Canadian HA auditors, Polish HA auditors to explain raw data of assigned projects as well as explaining features, data and setup of Chromatography software as a system owner. Coordination with QA to ensure document initiation and closure related to relate to qualification, SOP’s, Protocols and deviation document complies.

Providing trainings to new recruits in regard to preparation of protocols, SOP’s and ensure the compliance in accordance with GLP.

Preparing product specifications and test procedures, preparation/Review of SOP’s for operation and calibration of various instruments.

Handling of Change Controls, Laboratory Investigations and Lab deviations.

Dr. Reddy’s Laboratories Ltd., INDIA Assistant Manager – Analytical R & D Mar 2009–Aug 2010

Features:

Leading a team of associates in Analytical research and development at IPDO (Integrated Product Development Organisation)

Development, Validation and Method transfer of analytical methods for drug products as per ICH guidelines. (Assay, Degradation products, Dissolution etc…)

Stability studies of drug product’s as per guidelines.

Responsible for review of analytical raw data, Periodic calibration of analytical instruments. Handling of documentation of results, preparing SOP’s and development History Reports. Exposure of handling OOT, OOS and deviations at laboratory.

To ensure the compliance of laboratory functions with international regulatory guidelines, Co-ordinate with production and QA for related activities.

To ensure that written procedures are followed in the execution of the various laboratory functions and are documented at the time pf performance. Any deviation from the written procedure recorded and justified.

Excellent interpersonal, communication and organizational skills to expedite deliverables for assigned projects DP activities in different phases.

Have a zest to perform al analytical activities in complete GMP environment in compliance with GLP guidelines.

Sandoz Pharmaceutical, INDIA. Scientist III – Analytical R & D Dec 2005 – Feb 2009

Features:

Development, Validation and Method transfer of analytical methods for drug products as per ICH guidelines. (Assay, Degradation products, Dissolution etc…)

Stability studies of drug product’s as per guidelines.

To ensure the compliance of laboratory functions with international regulatory guidelines, Co-ordinate with production and QA for related activities.

Responsible for troubleshooting and project related issues in the laboratories as well as for the projects running with third parties.

Expertise in forced degradation studies, impurity profiling, excipient compatibility studies, QbD and DoE testing’s for lab scale as well as Pilot phase DOE

Emcure Pharmaceutical, India Research Associate Jul 2004 – Nov 2005

Features:

Analytical method development and validation. Performing stability analysis as per guidelines.

Okasa Pharmaceutical, India Technical Trainee June 2003–June 2004

Features:

Analytical method development and validation. Performing stability analysis as per guidelines.

Performing qualifications and calibration of analytical instruments.

Evaluations of working standards.

Bharat Serums and Vaccines Ltd, India Trainee July 2002–May 2003

Features:

Analytical method development and validation for vaccines (Injectable).

Performing qualifications and calibration of analytical instruments.

EDUCATION

2002 Masters in Analytical Chemistry Shivaji University Kolhapur

1999 Bachelor’s of Science in Chemistry Shivaji University Kolhapur

1996 H.S.C. Kolhapur Board

1994 S.S.C. Kolhapur Board

AWARDS AND RECOGNISITIONS

2012 Received a team award for participation in internal Audits as well as Health Authority Audits.

2012 Received multiple awards for successful completion and submission of assigned projects.

2013 Received global award (Above and Beyond) from Novartis Global Development Head for chromatographic solutions.

2013 Recognised as a team player for the setting up of new laboratory in compliance with global as well as regulatory requirements.

2016 Recognised with the Star award for the integration of Oncology Portfolio from GlaxoSmithKline to Novartis Pharmaceuticals

PERSONAL

DOB: 1st June 1979

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