Senior Regulatory Affairs and Quality Consultant

Accomplished pharmaceutical regulatory consultant with over 18 years of experience across NDA, ANDA, OTC, medical device, and cosmetic product sectors. Known for expertise in FDA submissions, data integrity audits, and regulatory strategy, with a strong focus on Chemistry, Manufacturing, and Controls (CMC). Proven ability to establish effective communication with the FDA, manage complex regulatory projects, and support product launches. Skilled in managing cross-functional teams and developing quality and regulatory processes to enhance compliance and efficiency.

Key Areas of Expertise

  • Regulatory Submissions (NDA, ANDA, DMF)
  • CMC and Labeling Submissions
  • Data Integrity and Quality Compliance Audits
  • FDA Communication and Regulatory Strategy
  • eCTD Submissions and Post-Approval Changes
  • Project Management and Process Improvement

Professional Experience

Consultant – Global Pharma Consultants, LLC / Senior Manager, Regulatory Affairs - Professional Disposables International, Inc. (PDI)
Various Locations | 2015-Present

  • Conducts quality and data integrity audits for client companies in compliance with FDA ALCOA principles, supporting data accuracy and compliance for critical regulatory filings.
  • Provides regulatory strategy and prepares submissions, including CMC sections for DMFs, NDAs, and ANDAs.
  • Acts as primary FDA contact for clients, managing all communications, coordinating pre-IND meetings, and advising on regulatory strategy for products in pharmaceutical, OTC, medical device, and cosmetic categories.
  • Drafted CTD modules, managed post-approval supplements, and coordinated IND submissions and amendments.

Manager/Senior Manager, Regulatory Affairs – Professional Disposables International, Inc. (PDI) / Nice-Pak Products
Orangeburg, NY | 2012-2015

  • Managed Regulatory Affairs team overseeing Pharma, OTC, medical device, and cosmetic products, including responsibilities for NDA, OTC drug, and 510(k) medical device submissions.
  • Supported product compliance, including label supplements, IND submissions, NDA Annual Reports, and stability program implementation in compliance with ICH guidelines.
  • Led quality team initiatives, filed an sNDA for new claims, and submitted PDI’s first 510(k) premarket notification, estimated to increase sales by $20 million.
  • Spearheaded the creation of regulatory databases, including Master Lists and ingredient and claims databases, to improve process efficiency.

Senior Regulatory Analyst – Roxane Laboratories, Inc.
Columbus, OH | 2007-2012

  • Managed, authored, and filed approximately 20 ANDAs, multiple supplements, and annual reports, leading efforts for all international third-party projects.
  • Provided regulatory guidance for products from development through approval, managed CMC deficiency meetings, and supported new product launches.
  • Led initiatives to implement eCTD submissions and regulatory documentation, resulting in cost and time efficiencies.

Chemist, QC Launch – Boehringer-Ingelheim Roxane, Inc.
Columbus, OH | 2003-2007

  • Led analytical transfer projects, supporting nasal and solid powder inhalation products. Conducted gap analyses and implemented right-first-time initiatives, ensuring accuracy in testing.

Scientist, Analytical Development Laboratory, R&D – Torrent Pharmaceutical Ltd.
Ahmedabad, India | 1994-1996

  • Supported testing for development lots in Formulation Development, gaining expertise in HPLC, GC, FTIR, and other laboratory techniques across various dosage forms.

Education
Master’s in Chemistry
Banaras Hindu University, India

Honors Diploma in Systems Management
NIIT, India

Certifications and Training

  • Project Management Certificate – Xavier University of Cincinnati
  • Basic Drug Development Certificate – Temple University
  • Management Level Coaching – BI/Roxane Laboratories

Professional Accomplishments

  • Filed over 20 ANDAs and more than 50 annual reports, including in eCTD format.
  • Developed regulatory strategies that facilitated first FDA approvals for internationally developed products.
  • Supported and launched over 20 generic products, managed large-scale international projects, and implemented significant process improvements in change management and documentation.

Skills

  • Proficient in Microsoft Office, Trackwise, Documentum, and eCTD submissions.
  • Strong communication, negotiation, and project management abilities.

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