Hamir Malia
Independent Consultant - 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬 and other industries at Independent | Greater Boston
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Hamir Malia is a seasoned Independent Consultant in the Life Sciences sector, leveraging his extensive background from McKinsey and BCG to deliver high-impact strategies and innovative solutions for Global 2000 clients, Private Equity firms, and established consulting companies. With over 20 years of experience, Hamir specializes in a diverse array of areas including business strategy, technology optimization, and enterprise transformation, making him a sought-after advisor for CxO-level executives across various industries. His current role involves spearheading key projects that focus on regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls) for biologics and pharmaceuticals.
Hamir's expertise encompasses a wide range of regulatory processes, including IND, BLA, NDA, and ANDA filings, as well as compliance with GMP, GCP, and GLP standards. He has successfully led nearly 200 projects, collaborating with cross-functional teams of former consultants from top-tier firms like Bain and Booz Allen Hamilton. His work often involves conducting due diligence, enterprise architecture assessments, and program management, ensuring that clients navigate complex regulatory landscapes while optimizing their supply chain and quality management systems.
In addition to his regulatory and strategic prowess, Hamir is proficient in data science and analytics, utilizing these skills to drive informed decision-making and enhance operational efficiencies. His comprehensive understanding of translational medicine, pharmacovigilance, and biostatistics further positions him as a valuable asset in the Life Sciences domain. As he continues to engage with clients, Hamir remains committed to fostering innovation and excellence, helping organizations achieve their strategic objectives in an ever-evolving marketplace.
Independent Consultant - 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬 and other industries at Independent in January 2004 to Present
Book Author at 𝗙𝗥𝗢𝗠 𝗔 𝗙𝗜𝗥𝗘𝗛𝗢𝗦𝗘 in January 2021 to Present
Founder and President at Best Expert InSight ( BEIS ) in January 2012 to Present
Senior Vice President at OpSec Security in January 2003 to January 2004
Vice President at Lavastorm Analytics in January 2000 to January 2003
Senior Principal at The Boston Consulting Group (BCG) in January 1998 to January 2000
Engagement Manager at McKinsey & Company in January 1995 to January 1998
Associate Director at Cambridge Technology Partners in January 1993 to January 1995
Client Partner at Gartner Group in January 1992 to January 1993
Project Manager at IBM in January 1989 to January 1990
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Cornell Johnson Graduate School of Management, MBA, January 1990 to January 1992
Cornell University, M. Eng., January 1990 to January 1991
Penn State, M.S., January 1984
University of Baroda, B.S., January 1980
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CMC Regulatory Affairs
API Development
Chemistry, Manufacturing, and Controls (CMC)
Regulatory Affairs
Regulatory Compliance
Regulatory Requirements
Medical Devices
Medical Affairs
Common Technical Document (CTD)
Electronic Common Technical Document (eCTD)
msat
Technical Operations
module 3
module 2
CMC | APIs | Sterile | MSAT | Formulation | Analytical | Module 3 | Regulatory Affairs | RA | GMP | GCP | GLP | BLA | Submission | Dossiers | FDA | CTD | eCTD | TMF | Technology Transfer | Quality | SCM | Supply Chain | Process Development | Translational Medicine | Pharmacovigilance | PV | PK | Protein Expression | Bioprocess | Downstream Processing | Biostatistics | Statistical analysis | Medical Affairs | Quality by Design | Biologics process | Analytical development | IND/BLA/PAS/NDA/ANDA Regulatory Filings | Assay development | Scale-up | Global Labelling | RIMS | Validation | CSV | ISO13485 | ISO14971 | 510(K) | Module 1 | Module 2 | QMS | Quality Assurance | CAPAs | CMO | Deviations | Remediations | Combination Products | CRO | CDMO | LIMS |
Project Planning
Management Consulting
Strategy
Pharmaceutics
Cross-functional Team Leadership
Business Transformation
Business Development
Program Management
Supply Chain
Project Management
Management
Business Strategy
Energy
Change Management
Leadership
E-commerce
Process Improvement
Professional Services
Business Process Improvement
Due Diligence
Business Intelligence
Start-ups
Analytics
Business Analysis
Business Analytics
Mergers & Acquisitions
Competitive Analysis
Product Management
Consulting
Strategic Planning
Financial Modeling
Business Planning
Analysis
IT Strategy
Expert Insight
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What is Hamir Malia email address?
Email Hamir Malia at [email protected] and [email protected]. This email is the most updated Hamir Malia's email found in 2024.
How to contact Hamir Malia?
To contact Hamir Malia send an email to [email protected] or [email protected].
What company does Hamir Malia work for?
Hamir Malia works for Independent
What is Hamir Malia's role at Independent?
Hamir Malia is Independent Consultant - 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬 and other industries
What is Hamir Malia's Phone Number?
Hamir Malia's phone (**) *** *** 255
What industry does Hamir Malia work in?
Hamir Malia works in the Management Consulting industry.
Hamir Malia Email Addresses
Hamir Malia Phone Numbers
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