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Narottam Shinde profile image

Narottam Shinde

Associate Vice President, Research & Development, Hyderabad at Hetero
Intro Book
Narottam Shinde, a seasoned pharmaceutical professional with expertise in regulatory affairs, formulation, and quality control, holds a Six Sigma Black Belt and various diplomas in quality auditing, patent law, and clinical research.
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Location
Greater Hyderabad Area, IN
Languages
  • English Full professional proficiency
  • Marathi Native or bilingual proficiency
  • Hindi Professional working proficiency
  • Gujarati Professional working proficiency
Skills
  • Hardworking And Dedicated To Anda Development
  • Regulatory Affairs
  • Generic Programming
  • Formulation
  • Pharmaceutical Research
  • Show all
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Bio

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Narottam Shinde, a seasoned executive with a strong background in pharmaceutical research and development, brings a wealth of experience in regulatory affairs, formulation, and quality control. As Associate Vice President, Research & Development at Hetero Labs, he successfully spearheaded the development of a dedicated USFDA-compliant facility, delivering five ANDA's within a 10-month span. Shinde holds various certifications, including a Post Graduate Diploma in Clinical Research and a Six Sigma Black Belt, demonstrating his expertise in clinical trials, quality control, and process improvement.

Credentials

  • PMP® Certification Training Course
    Simplilearn
    Nov, 2021
    - Apr, 2026
  • 14 Things to Do When You Lose Your Job
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • 15 Secrets Successful People Know about Time Management (getAbstract Summary)
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • 20 Questions to Improve Learning at Your Organization
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Asking for Feedback as an Employee
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Become a Project Management Entrepreneur
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Boosting Your Confidence, Public Speaking and Performance
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Building Self-Confidence
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Communicate to Influence (Blinkist Summary)
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Creating a Meeting Agenda
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Creating Flowcharts for Beginners
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Creating Great First Impressions
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Crunch Time: How to Be Your Best When It Matters Most (getAbstract Summary)
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Dealing with Difficult People in Your Office
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Demonstrating Accountability as a Leader
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Digital Body Language
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Enhance Your Productivity with Effective Note-Taking
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Excel: You Can Do This
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Getting into the Mind of the Hiring Manager
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Handling Outsourcing Issues
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Holding Your Team Accountable
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Holding Yourself Accountable
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • How Getting Curious Helps You Achieve Everything
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • How to Be Promotable
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • How to Build Rapport Quickly
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • How to Develop your Career Plan
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • How to Manage Your Manager
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • How to Present and Stay on Point
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • How to Stand Out
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • How to Succeed in an Internal Job Interview
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • How to Use LinkedIn Learning
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Humble Leadership: The Power of Relationships, Openness, and Trust (getAbstract Summary)
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Improving Your Thinking
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Lean Six Sigma Foundations
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Lean Six Sigma: Define and Measure Tools
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Lean Technology Strategy: Building High-Performing Teams
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Learning from Failure
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Learning to Say No
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Listen to Lead
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Making Quick Decisions
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Management Tips
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Managing Meetings
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Managing Stress
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Mistakes You Should Avoid at Work
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Organizational Culture
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Outlook: Automating Your Email with Mail Rules
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Preparing Yourself for Change
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Project Leadership
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Project Management Foundations: Requirements
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Recharge Your Energy for Peak Performance
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Rules for Rising Leaders
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Six Sigma: Green Belt
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Stepping Up: How Taking Responsibility Changes Everything (getAbstract Summary)
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Stop Stressing and Keep Moving Forward
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Strategic Thinking
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Succeeding as a First-Time Tech Manager
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Succeeding in a New Role By Managing Up
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • The Leader Habit (Blinkist Summary)
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • The Practices of High-Performing Employees
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • The Secret: What Great Leaders Know and Do (getAbstract Summary)
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • The Step-by-Step Guide to Building your Thought Leadership on LinkedIn
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Transitioning from Manager to Leader
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Ways to Build a Winning Team: Trust, Freedom, and Play
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • Word: Formatting and Styles in Depth (365/2019)
    LinkedIn
    Feb, 2021
    - Apr, 2026
  • 20 Questions to Help You Start a Business
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Becoming an Impactful and Influential Leader
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Building High-Performance Teams
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Business Etiquette: Phone, Email, and Text
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Communicating in the Language of Leadership
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Critical Thinking for Better Judgment and Decision-Making
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Decision-Making in High-Stress Situations
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Delegating Tasks
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Entrepreneurship Foundations
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Entrepreneurship: Finding and Testing Your Business Idea
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Gemba Kaizen: A Commonsense Approach to Continuous Improvement (Blinkist Summary)
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Getting Things Done
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • How to Organize Your Time and Your Life
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • How to Rock an Interview
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • How to Train Your Brain for Maximum Growth
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • How to Work Smarter, Not Harder: Save Time and Money and Increase Productivity
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Increase Visibility to Advance Your Career
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Lead Like a Boss
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Leadership Fundamentals
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Leading and Managing the Whole Self
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Leading in Crisis
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Managing Conflict: A Practical Guide to Resolution in the Workplace (getAbstract Summary)
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Meditations to Change Your Brain
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Motivating and Engaging Employees
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Operational Excellence Work-Out and Kaizen Facilitator
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Overcoming Your Fear of Public Speaking (2014)
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Speaking Up At Work
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Start with Why: How Great Leaders Inspire Everyone to Take Action (Blinkist Summary)
    LinkedIn
    Jan, 2021
    - Apr, 2026
  • Unconscious Bias
    LinkedIn
    Jan, 2021
    - Apr, 2026

Experience

  • Hetero
    • Hyderabad, Telangana, India
    • Associate Vice President, Research & Development, Hyderabad
      • Dec 2021 - Present
      • Hyderabad, Telangana, India

      Hormone Niche Portfolio "Womens Health Niche" _ Hetero Labs, Came Up with a Sparlking New Dedicated USFDA Compliant Facility with short period of 10 months, delivered 5 ANDA's within Span of 10 Months expecting FDA Audit hence, got enrolled & completed " DIploma in Quality Auditing"

  • Naari Pharma Pvt Ltd.
    • India
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Senior General Manager
      • Dec 2018 - Jun 2021

    • General Manager
      • Jan 2016 - Dec 2018

      Generic High Potent and 505(b)(2) Product development for regulated Market; US, EU, AUS & WHO. Looking ahead lean commercial manufacturing was need of market hence , enrolled for Lean Si Sigma Black belt and completed with distinction.

  • IPCA Laboratories Ltd.
    • Mumbai Area, India
    • Deputy General Manager
      • Jul 2014 - Jan 2016
      • Mumbai Area, India

      - Responsibility: Generic Drug Product Development for Regulated Mkt Like US, EU, AUS & WHO. - Development of High Potent Hormonal & Non Hormonal product. - New R&D, Hormone ANDA Lab Setup at Indore location. - Response provided to queries raised by regulatory authorities for products filed few years back. - Career Path: Looking at current FDA perspective towards packaging of hormonal products made me enroll for "diploma in packaging development and management, Grade - First Class" & gained in-depth knowledge and expertise in understanding the critical quality attribute involved in pharmaceutical packaging.

  • Famy Care Ltd.
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Senior Principal Scientist
      • Jul 2012 - Jul 2014

    • Manager (Group Leader), Level 07 - Formulation Deelopment
      • Jul 2010 - Jul 2014

      - Excellent opportunity of handling high potent hormonal formulations dose as low as 10mcg. - Key person involved in USFDA Audit & providing responses raised by auditors.- Acquired leadership qualities via handling a team of scientist. - Career Path: This was the phase when understood the importance of Quality Function (QA & QC) hence, got enrolled and acquired first class position in "Diploma in Quality Control & Quality Assurance"

    • Principal Scientist
      • Jul 2011 - Jun 2012

  • Rusan Pharma Ltd, Mumbai.
    • Kandivali, Mumbai, Maharashtra, INDIA
    • Manager - Formulation Dept.
      • Jan 2009 - Jul 2010
      • Kandivali, Mumbai, Maharashtra, INDIA

      A different segment of pharmaceutical where successfully proved my capabilities by developing a sub -cutaneous implant with a predefined release pattern for a month. Faced N-Numbers of challenges right from seeking local FDA license, Patent hurdles, followed by product development within stipulated time frame, and export into Russian market. The developed subcutaneous implant was subjected for clinical trials in Russia and was well appreciated by Russian doctors. In-addition had another great opportunity in developing number of generic injectable (PFS) dosage forms. Career Path: This was phase wherein understood importance of patents hence, got enrolled & acquired First Class grade in "Post Graduate Diploma in Patent Law & Practice" GNA Patent Gurukul under guidance of "Dr. Gopakumar Nair"

  • AUROBINDO PHARMA LTD
    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Research Associate IV
      • Oct 2007 - Jan 2009

    • Research Associate III - Formulation DeVELOPMENT
      • May 2006 - Sep 2007

      - Aurobindo Pharma, leaders in generic development and regulatory fillings for US & EU Mkt.- A company where the concept of "ANDA" got cleared, highly motivated towards making the career in "generics" wherein the goal was set with vision to be an subject matter expert in "ANDA" development.- Excellent support from colleagues and boss who handed over company's KRA products wherein, worked day in and out & formulated a "Bio-equivalent" Product - In hand experience of handling Solid & Liquid Dosage form, from pre-formulation to EB Mfg. - A company, where all working hands on project right from scientist, team leader use to have round table discussion on "Product Progress, Setting Specification, Exhibit Batch Results, IVIVC Co-relation & finally Bio-Equivalent Report" Felt lacking in Pk data interpretation hence, got enrolled & acquired First Class grade in "Post Graduate Diploma in Clinical Trials" (BABE Study) CREMA, Mumbai.

  • Emcure Pharma Ltd, Pune.
    • Hingewadi, ITBT Park, Pune,Maharashtra,INDIA
    • Research Associate - Formulation Development
      • Jan 2004 - May 2006
      • Hingewadi, ITBT Park, Pune,Maharashtra,INDIA

      Domestic experience for a year followed by shouldering the responsibility of ANDA Lab Setup and finally appointed as a first person to work on generic drug development, ANDA Submissions for US Mkt.

Education

  • 2020 - 2021
    Simplilearn
    Six Sigma Black Belt / Expert., Efficiency & Productivity Improvement
  • 2014 - 2015
    Institute of Pharmaceutical Education Research
    Diploma in Pharmaceutical Packaging and Management, First Class
  • 2013 - 2014
    Institute of Pharmaceutical Education Research.
    Diploma in Quality Control & Quality Assurance, First CLass.
  • 2009 - 2010
    GNA's Patent Gurukul.
    Post Graduate Diploma in Patent Law & Practice, Patent Law
  • 2007 - 2008
    Clinical Research Education and Management Academy
    Post Graduate Diploma in Clinical Research., Bioequivalence Study
  • 2000 - 2002
    Poona College of Parmacy
    Master of Pharmacy, Pharmaceutis & Quality Assurance.
  • 1996 - 2000
    MGV's College of Pharmacy,
    Bachelor's degree, Pharmaceutical scieces
  • 1994 - 1995
    KES'S PRATAP COLLEGE, AMALNER.
    Higher Secondary Certificate
  • 1992 - 1993
    Canossa Convent High School, Dhule
    Secondary School Certificate, Second Class
  • 2023 - 2023
    Insight Professional Academy
    Diploma in Quality GMP Auditing., Auditing Skills

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