Summary
Overview
Work History
Education
Skills
Professional Highlights
Publications And Awards
Timeline
Generic

Devendra Mali

Delhi

Summary

Results-driven corporate affairs leader with an Executive MBA from FMS, University of Delhi, and 13+ years of expertise in pharmaceuticals, healthcare, and nutraceuticals. Proven ability in government relations, advising leadership, regulatory consulting, and securing critical approvals. Strong track record of success in influencing policy decisions and driving business impact through strategic partnerships with 60+ bureaucrats and policymakers.

Overview

15
15
years of professional experience

Work History

Manager, Corporate Affairs and Government Relations

Zydus Life Sciences Ltd.
Delhi
09.2023 - Current
  • Developed and maintained credible relationships with key stakeholders in ministries including, Commerce, Environment, Agriculture, IPC, and, other departments
  • Secured over 30 input-output norms product approvals and import authorizations for restricted items from DGFT, facilitating seamless export and R&D operations
  • Successfully obtained crucial approvals from DGFT, Animal Husbandry, and DBT, reducing approval timelines by 30%
  • Led cross-functional collaboration with commercial, strategy, regulatory, R&D, and EXIM teams to identify key business challenges, influence policymaking, and drive strategic regulatory solutions
  • Conducted in-depth policy analysis on research and innovation, compliance, ease of business, and industry best practices, compiling impact assessments for the Zydus portfolio to guide strategic decision-making
  • Monitored trade policies, customs, and tariffs, ensuring compliance and facilitating seamless business operations
  • Represent the company in key industry committees, meetings, and events, fostering stakeholder relationships and positioning the organization as a thought leader

Sr. Manager, Regulatory Affairs and Government Relations

Dr. Willmar Schwabe India
Noida
02.2022 - 08.2023
  • Built strong relationships with central and state government bodies to drive product adoption in public markets
  • Secured 20+ product registrations with FSSAI, State FDAs, and Ayurveda authorities, enabling market expansion
  • Led 5+ regulatory audits and inspections, securing GMP, organic (NPOP, NOP), food safety, and Export Inspection Agency certifications
  • Enabled a facility to achieve US-FDA recognition by implementing 21 CFR 117 and HACCP
  • Ensured product labels and marketing materials met all regulatory requirements
  • Project Management: Spearheaded 3+ clinical and nutraceutical studies in India, overseeing CRO selection, budget negotiation, and study initiation
  • Tracked patient enrollment and monitored study progress for timely execution
  • Directed EU-GMP and US-FDA site preparedness projects by selecting and collaborating with expert consultants

Manager, Corporate Relations

Sun Pharmaceutical Industries Ltd.
Delhi
11.2016 - 01.2022
  • Developed and maintained relationships with key stakeholders, including CDSCO, Ministry of Ayush, Department of Biotechnology
  • Managed multi-level stakeholder engagement to resolve operational challenges in regulatory, manufacturing, imports, exports, NSQ, and product complaints
  • Led critical regulatory projects, securing over 25+ clinical trial and bio-study waivers, 5+ first-to-file approvals, 30+ market authorizations, and 2 COVID-19 drug clearances
  • Attended and participated in SEC in CDSCO and RCGM in DBT meeting for regulatory clearance
  • Policy Advocacy: Advised on phyto-pharma drug regulations in collaboration with the Ministry of Ayush, CCRAS, and CDSCO, facilitated seamless regulatory submission
  • Successfully advocated for policy changes, including clarity on pharmaceutical storage labeling | Simplified import/export procedures for GE organisms (DBT notification, Jan 17, 2020)
  • Facilitated Ease of Doing Business reforms, including shifting Oxytocin API from the prohibited to the restricted import list | Reducing BA/BE study protocol fees for exports

Technical Associate

National Institute of Biologicals, Government of India
Noida
11.2012 - 11.2016
  • Reviewed 30+ product dossiers to ensure strict regulatory compliance
  • Conducted data-driven assessments to address queries from ministries and regulatory agencies effectively
  • Collaborated on a national drug survey (47K+ samples, 654 districts, 224 molecules) identifying 3.16% NSQ and 0.2% spurious drugs, reinforcing quality assurance

Business Executive

Wockhardt Ltd.
Indore
04.2011 - 11.2012
  • Achieved 100% revenue target (INR 80 lakh) in Madhya Pradesh with 10% growth in 18 months through B2B & B2C sales initiatives
  • Expanded market reach by engaging 80+ doctors, 200+ pharmacies, and 10+ stockists, driving territory development
  • Led B2B sales in Jabalpur, defence (Army) hospitals, 100+ clinics, and 6+ corporate accounts, including Apollo & medical colleges

Business Development Executive

Resilient Cosmeceuticals Pvt. Ltd.
Indore
02.2010 - 04.2011
  • Expanded territories in Madhya Pradesh driving revenue growth from zero to INR 29L
  • Boosted brand presence through 10+ CMEs in hospitals, successfully launching products across key verticals
  • Improved maternal health by introducing an anemia prevention product and implementing the 'Iron Deficiency Program' in hospitals

Education

MBA - Marketing

Faculty of Management Studies (FMS), University of Delhi
Delhi
01.2021

Post Graduate Program - Clinical Research and Drug Development

Focus Educare of Clinical Research
Indore
01.2012

M.Sc. - Biotechnology

Punjab Technical University
Indore
01.2009

Skills

  • Regulatory and Policy Acumen
  • FSSAI Regulations
  • Drugs & Cosmetics Act
  • Project management
  • Analytical thinking
  • Strategic thinking
  • Problem-solving
  • Networking and relationship-building
  • Negotiation and Influence
  • Crisis management
  • Presentations
  • Budgeting

Professional Highlights

  • Consulting and Advising: 8+ years of delivering strategic insights and customized solutions for business growth
  • Stakeholder Management: 10+ years of successfully aligning stakeholders to drive strategy, achieving a 20% boost in project efficiency
  • Sales Strategy: 3 years of B2B and B2C sales strategy experience, maximized conversions, and sales growth

Publications And Awards

  • International Journal of Current Research, 07/01/15, Describe how various diagnostic centers are shifting away from COLORIMETRIC IMMUNOASSAYS and toward CHEMILUMINESCENT IMMUNOASSAYS for the diagnosis of HBV, HCV, and HIV., http://www.journalcra.com/article/inclination-towards-chemiluminescent-immunoassays-comparison-colorimetric-immunoassays
  • 125% achievement of sales target, Wockhardt Ltd (Dermatology)

Timeline

Manager, Corporate Affairs and Government Relations

Zydus Life Sciences Ltd.
09.2023 - Current

Sr. Manager, Regulatory Affairs and Government Relations

Dr. Willmar Schwabe India
02.2022 - 08.2023

Manager, Corporate Relations

Sun Pharmaceutical Industries Ltd.
11.2016 - 01.2022

Technical Associate

National Institute of Biologicals, Government of India
11.2012 - 11.2016

Business Executive

Wockhardt Ltd.
04.2011 - 11.2012

Business Development Executive

Resilient Cosmeceuticals Pvt. Ltd.
02.2010 - 04.2011

MBA - Marketing

Faculty of Management Studies (FMS), University of Delhi

Post Graduate Program - Clinical Research and Drug Development

Focus Educare of Clinical Research

M.Sc. - Biotechnology

Punjab Technical University

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Devendra Mali