Narendra Vutla
San Diego,CA
Summary
To obtain a position that enables me to contribute towards growth of the organization by using my diverse experience, proven leadership style and entrepreneurial skills.
Global techno-commercial research leader and entrepreneur with a experience in leading global R&D teams responsible for developing differentiated products for pharmaceutical and biotechnology sectors. Managed various functions of R&D including clinical development, regulatory affairs, product and portfolio management. Partnered with commercial and development teams across the globe to deliver patient centric innovations that address unmet medical needs. Demonstrated success in bringing pharmaceutical and biotherapeutic products to the market. Established new sites and facilities. Familiar with ISO standards, Quality Systems, and FDA/EMA regulations. Specialized training in biotechnology, biotherapeutics, clinical pharmacy and pharmaceutics. Professional consultant with track record of providing valuable insights and strategic solutions to diverse clients. Adept at leveraging analytical skills and industry knowledge to drive impactful outcomes. Known for fostering team collaboration and adapting to dynamic environments, ensuring project success and client satisfaction.
Overview
29
29
years of professional experience
1
1
Certification
Work History
Freelance Consultant
(Transistional Role)
02.2025 - Current
- Providing intermittent consulting services to clients on new products and regulatory strategy for 2 different clients.
- Connecting clients with CDMOs for outsourcing development activities and sourcing commercial supplies
President/CEO
Ritsa Pharma Pvt Ltd.
07.2023 - 01.2025
- Company Overview: A small CDMO catering for US Market
- Lead operation of Ritsa Pharma organization
- Responsible for overseeing not only enterprise P&L but also lead development and commercial manufacturing of RX products for clients and manage relationships
- Mentor and lead teams, fostering a culture of excellence and continuous improvement
- Manage leadership team members including business development and finance functions
- Manage the entire life cycle management of from ideation through commercial manufacturing with minimal support from client
- A small CDMO catering for US Market
- Successful USFDA inspection of manufacturing plant with zero observations, which paved the way for 6 ANDA approvals
- Established contracts with reputable clients like Abbott, Novartis, Rising, Aries Pharma, SKG Pharma, GALT, Azurity etc
- And improved revenue stream to reach breakeven stage within a brief period
- Signed contracts involve product development, manufacture of clinical supplies and 3P manufacturing of commercial supplies dedicatedly for US market
- Six products are already in the US market
- B2B services included facilitation of biosimilars deals with a third-party company from gene to clinical stage
Sr. Director & Site Head, Innovation and Development
Abbott Pharmaceuticals
07.2020 - 04.2023
- Company Overview: Member of global leadership team of Abbott
- Accountable for delivery of growth portfolio in collaboration with commercial teams as part of category growth leadership team for global as well as regional markets
- Oversaw development of differentiated innovations to address unmet medical needs
- Portfolio included drug device combination products to improve adherence and outcomes
- Evaluated external innovation and patent landscape to identify potential in-licensing opportunities
- Part of global R&D leadership core team member, advising product portfolio innovation across continents
- Supported building external partnerships to deliver products in oncology, women’s health, and respiratory diseases in emerging markets
- Accountable or co-accountable for identifying external CDMO and CRO networks to award projects where internal capabilities were not sufficient or did not exist
- As a site lead and member of regional leadership team, accountable for managing functional teams including product development, site operations, clinical development, medical affairs, quality Assurance, project management, portfolio innovation and regulatory etc
- Provided guidance and allocated budgets for clinical development programs
- Conducted ideation workshops across the globe in target geographies to identify emerging trends, market gaps and product opportunities (Brazil, Switzerland, Italy, Vietnam, Thailand, etc.)
- Successfully navigated the organization entering new areas of opportunities in oncology and Women’s health therapeutic areas and biology as new classes of medications
- Supported sustained innovation focusing on top 20 brands for Indian market
- Extensively involved in the clinical development of Women’s Health hormone portfolio and devices
- Member of global leadership team of Abbott
- Delivered innovation sales of 1.6% to support sales of $1182 mn for India market in 2021
- Ideated a risk adjusted portfolio to deliver an increase in portfolio value from 1.5% in 2020 to and to 3% in 2023 April (to deliver target sale growth of 3% by 2025)
- Some of the global brands supported; Vertin, Brufen, Kenacort, Follihair, Melaglow, LibriumTM, ThyronormTM, DuphastonTM, CreonTM, DigeneTM and AbvidaTM
- Key contributor of a strategy to introduce biosimilar portfolio to Abbott EPD worldwide and resulted in 300mm sales growth opportunity by 2030 @20% market capture (Indian market size was 360mn in 2020 and forecasted to reach 1.5bn by 2030)
- The first successful biosimilar mAb launch in 2023 was Bevacizumab (Avastin) in LATAM
- Managed R&D budget of 63mn for 2022 toward pipeline development and third-party launches
- Innovation resulted in first in the world product launch in India Ivabid OD and simple packaging innovation for levothyroxine bottle cap resulted in huge improvement in patient adherence
- Conceptualized and delivered rapid acting product portfolio as drug device combination products
Sr. Director & Site Lead, Global R&D Center
GSK CH
01.2012 - 06.2020
- Company Overview: Global Category Lead for topical pain relief
- Accountable for development of innovation pipeline and localization of global products with needed reformulation to support GSK Asia
- Accountable for product remediation to protect sales and improve cost savings by reformulating existing products
- Site Head for R&D Technical Excellence center and Pilot Plant Operations
- Managed teams across regions
- Implement QBD and dtv principles into design of new formulations and processes
- As a site leader and member of leadership team, accountable for managing functional teams including product development, site operations, clinical, medical affairs, quality and regulatory etc
- Oversee scaleup and technology transfer of products to various global sites
- Lead the global ENO CoE and supported GI category with development of products and claims for global markets (Brazil, Spain, Africa, Asia, etc.)
- Ideated and oversaw successful development of AI and digital based system to automate product related query response
- Global Category Lead for topical pain relief
- Delivered NPD initiatives for wellness and oral health worth £29.3M in 2013 to support a £102M portfolio within ISC, and worth £60M in 2014/2015 to support a £500M portfolio globally
- Delivered aspirational target of 15% innovation to sales ratio while supporting top line growth of 20% for three years in a row
- Supported delivery of record 22 NPD initiatives worth £74m in 2014
- As a Board Director of GSK Asia Pvt
- Ltd., oversaw P&L for revenues of £125m in 2014
- As an interim global topical pain relief category lead based out of Singapore, collaborated with category commercial to build a pipeline which was worth of £100m sales for emerging markets
- Delivered Savings of £16m during last two years by reformulating the existing products in various global markets including India
Vice-President and Partner
Newburgh Chemists, Inc
01.2009 - 12.2011
- Oversaw business development and Operational Management of a three-location compounding, clinical & retail pharmacy group, which was struggling financially
- Championed the turnaround strategy and increased the gross profit to 25% and delivered a net profit to sales ratio of 12% by improving top line growth and maximizing operational efficiency
- Accomplished top line growth of 20 percent 3 years in a row
Sr. Manager/Associate Director, Product Development
J&J and Pfizer Consumer Healthcare
08.2001 - 12.2008
- Company Overview: Acquired by J&J group
- Supported innovation pipeline, provided strategic directions, oversaw budgets, and assured timely launch of new products for US as well as global markets
- Commercialized products based on innovative technology platforms; modified solid oral dosage forms, quick dissolve films (filmstrip), micro-gels (seamless capsules), soft chews, topical rubs, and fast melt (orally disintegrating tablet) dosage forms
- Acquired by J&J group
- Part of Listerine pocketpaks (blockbuster innovation in CH business)
- Launched two additional variants plus two OTC products first time in film strips (first in the world innovation)
- Developed formulations to support new indications (sNDAs) and switches for Rx products including Zantac 150, Cetirizine, etc
Scientist/Manager, New Product Development
Elan Pharma and Ranbaxy Pharma
01.1996 - 07.2001
- Applied innovative electrostatic deposition technology to develop a controlled release pulsatile delivery system using Accudep technology and successfully completed early-stage trials
- Developed and commercialized generic solid oral dosage products (ANDAs) for the US market
First ANDA filed from a new site and got approval without any observations
Education
PharmD - Clinical Pharmacotherapeutics
MCPHS University
Boston, MAMS - Pharmaceutics (Biotherapeutics)
Auburn University
Auburn, ALSkills
- Problem-solving
- Product Ideation
- Team leadership
- Talent development
- Client relationships
- Product Development
- Enterprise Management
- Budget management
- Networking Capability
- Clinical Development
- Pharmacotherapy
- Excel under Ambiguity
Accomplishments
- Resolved product issue through consumer testing.
- Collaborated with team of [Number] in the development of [Project name].
- Documented and resolved [Issue] which led to [Results].
Awards Recognitions
- Earned Abbott Divisional excellence award for delivering patient centric innovation.
- Earned GSK R&D Excellence award for delivering Panadol transformation program.
- Earned gold award from LT for leading the operational systems simplification and digitalization of formulation query process.
- Additional recognition included CEOs/SLTs excellence awards for leadership, innovation, and exceptional performance with various organizations throughout career.
- Selected for global TOP 50 talent team of GSK in 2013.
Desired Job Locations
California, other locations if the job is hybrid with flexible work schedules., Willing to travel across the region or globe (up to 30%), No Relocation support needed
Board Certifications
Registered Pharmacist, New York
Personal Information
Citizenship: U.S. Citizen
Affiliations
- American Association of Pharmaceutical Scientist
Certification
New York State Registered Pharmacist
Timeline
Freelance Consultant
(Transistional Role)
02.2025 - Current
President/CEO
Ritsa Pharma Pvt Ltd.
07.2023 - 01.2025
Sr. Director & Site Head, Innovation and Development
Abbott Pharmaceuticals
07.2020 - 04.2023
Sr. Director & Site Lead, Global R&D Center
GSK CH
01.2012 - 06.2020
Vice-President and Partner
Newburgh Chemists, Inc
01.2009 - 12.2011
Sr. Manager/Associate Director, Product Development
J&J and Pfizer Consumer Healthcare
08.2001 - 12.2008
Scientist/Manager, New Product Development
Elan Pharma and Ranbaxy Pharma
01.1996 - 07.2001
PharmD - Clinical Pharmacotherapeutics
MCPHS University
MS - Pharmaceutics (Biotherapeutics)
Auburn University
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