Experience
Over 18 years of experience in the pharmaceutical industry with more than 12 years of experience in regulatory affairs and pharmaceutical development with primary focus on Chemistry, Manufacturing and Controls (CMC).
- Worked with renowned consulting groups to identify gaps and help remediate quality and regulatory processes.
- Worked with Quantic Group on a data integrity and remediation project with a major pharmaceutical company in India.
- Regulatory submissions including but not limited to providing regulatory strategy, writing CMC sections for DMFs (Section 2.3 and Module 3), NDA (505b2) and ANDA (505j) submissions.
- Quality and data integrity audit for clients per ALCOA principles.
- Negotiated and established cross-functional planning and timelines, writing, reviewing, and filing IND, ANDA, NDA (505b2) and DMF submissions.
- Led, managed and collaborated within and across internal and external teams from multiple countries.
- Mentored, motivated and developed direct reports and peers facilitating individual growth and team success.
- Provided regulatory strategy for NDA/ ANDA products, OTC Drug products, Medical Devices and Cosmetics.
- Established communication and develop rapport with FDA to gain approvals, support product launches to meet business requirements.
- Led pre-IND meeting with the FDA. Have been the primary point of contact for all FDA communications for the companies I worked with.
- Managed international projects with third party partnerships with tight deadlines.
- Initiated process improvements across organization including but not limited to Regulatory Affairs, Product Development, Quality Control, and Analytical Research & Development.
- Have authored, managed and filed over 20 ANDAs out of which 6 ANDAs were in eCTD format. Filed over 50 Annual reports out of which about 25 were filed in eCTD format. Have filed numerous supplements/ amendments to the FDA.
- Have worked on a variety of dosage forms including solid oral dosage, topical and nasal products.
- Various regulatory activities including but not limited to project management, deficiency responses, communicating with FDA, providing regulatory strategies to the business, extending support to the R&D, Quality and Operations, setting Release and Stability specifications for submission, Stability Protocol Design, Review Documents prior to submission, etc. for DMFs, NDA (505b2) and ANDAs (505j).
Skills
- Strategic regulatory guidance and planning leading up to development, FDA submissions and post-approval changes.
- Work efficiently with extremely tight timelines to meet stringent deadlines.
- Subject matter expert in analytical chemistry and cGMP/ ICH regulations.
- Ability to assess and convey regulatory risk and influence opportunities with both internal and external customers.
- Conversant with eCTD submissions.
- Excellent communication and negotiation skills.
Achievements
- Provided innovative regulatory solutions to project teams reach challenging goals during various stages of development leading up to filing and post approval.
- Filed over 20 ANDAs out of which 6 ANDAs are in eCTD format. Filed over 50 Annual reports out of which about 25 were filed in eCTD format. Have filed numerous supplements/ amendments to the FDA in eCTD format.
- Provided regulatory/ quality guidance to help the company achieve cGMP compliance.
- Regulatory responsibility from pre-approval through lifecycle.
- Regulatory submissions for ANDAs, NDAs, and INDs in eCTD format.
- Management of CMC and labeling submissions throughout the lifecycle of the project.
- Providing regulatory and analytical guidance to R&D and Quality per cGMP and ICH.
- Initiating and establishing procedures for international partnerships.
- Supporting Product Launch by providing regulatory expertise and guidance.
Core Expertise
Professional Certification and Training
- Basic Drug Development Certificate course(QA/RA program): Temple University
- BI/Roxane Laboratories’ Management Level Coaching
- Project Management Certificate: Xavier University of Cincinnati
Professional Accomplishments
- Worked with renowned consulting groups like Quantic Group and The FDA Group in various consulting projects, including regulatory strategy, submission, review, data integrity (ALCOA) and quality remediation projects for DMFs, NDA (505b2) and ANDAs (505j).
- Led and managed drug regulatory Affairs team for PDI healthcare. The products included NDA and OTC drug products as well as Medical Devices and Cosmetics. (PDI)
- Provided Regulatory guidance and helped PDI create a business strategy for new market opportunities. Based on the guidance provided, PDI is successfully pursuing at least five new business opportunities. (PDI)
- Provided Regulatory guidance and strategy to make post approval changes to the marketed product which allowed PDI to improve their product line without increasing the cost. (PDI)
- Led the Quality team to successfully implement an in-house stability program in compliance with ICH guidelines. Successfully helped Quality implement Stability Chambers to enable PDI to start stability testing for the NDA product thus ensuring cost saving for the company(PDI)
- Helped PDI create processes to manage the NDA per cGMP. Filed IND and its amendments, sNDA and several supplements for labeling changes. Filed and helped PDI obtain approval for a new labeling platform for PDI. (PDI)
- Filed 510K for PDI in e-copy format which was a first for PDI. (PDI)
- Primary contact with the FDA on all regulatory issues related to the NDA and the 510K. (PDI)
- Registered cosmetics in European Union per latest EC/2009 regulations which was a first for PDI/NP. (PDI)
- Helped PDI revamp the claims review process and the labeling process to ensure compliance with FDA and ISO. (PDI)
- Assessed eCTD vendors for PDI. Working with the vendor to implement eCTD software at PDI. (PDI)
- Provided regulatory/ quality guidance to help the company achieve cGMP compliance. (PDI)
- Filed over 20 ANDAs out of which 6 ANDAs were in eCTD format. Filed over 50 Annual reports out of which about 25 were filed in eCTD format. Have filed numerous supplements/ amendments to the FDA. (Roxane Laboratories, Inc. (RLI))
- Provided Regulatory guidance at various stages of development to the R&D team. Created Regulatory Strategy for NDA/ ANDA submissions as well as for CMC Post Approval changes. (RLI)
- Developed and managed on average 30-40 regulatory projects ranging from development through launch. (RLI)
- Responsible for all excipient changes and approval for over 120 approved products and over 250 SKUs. Ensure that quality, stability and sourcing understand regulatory risk and benefits at various stages of product development. (RLI)
- Filed the first eCTD submission and helped identify, choose and validate a software vendor. Developed a process for submitting all regulatory documents in eCTD submission. (RLI)
- Successfully supported and launched over 20+ generic products, including the first FDA approval for a product that was developed internationally. (RLI)
- Led and managed all aspects of the first international analytical transfer from Germany to Columbus. (Boehringer-Ingelheim Roxane Inc. (BIRI)).
- Successfully led several process improvements most impactful was the development of Processes for receiving, reviewing and filing documentation from third party partnerships and revamping the Change Management process within RLI and BIRI. Both processes provided significant cost and time savings to the bottom line. (Boehringer-Ingelheim Roxane, Inc.)
- Over 6 years’ experience in various Pharmaceutical Laboratories including Analytical and Quality prior to joining Regulatory.
- Honors Diploma in Systems Management, and expert in Microsoft Office Tools including Word, Excel and PowerPoint.
Professional Experience
Industry Consultant – Senior Manager, Regulatory Affairs - Professional Disposables International, Inc. (PDI)/ Nice-Pak Products
2015 to Present
Performed quality and data integrity audits for client companies based on ALCOA principles per FDA’s request to have third party oversight.
Working as a consultant with clients to help with regulatory strategy and submissions including writing CMC module (Section 2.3 and Module 3) for DMFs, NDA (505b2) and ANDAs (505j).
Worked as a consultant and acted as a senior executive for clients including Pharmaceutical, OTC products, Medical Devices and Cosmetic Products. Responsible for the registrations, compliance and regulatory strategies for the NDA, OTC, Medical Device and cosmetic products manufactured by the client.
Have been primary point of contact for all FDA communication for one of the clients. Represented client at various meetings and teleconference with the FDA.
Drafted CTD modules for DMF/NDA/ ANDA for the client. Helped client with Pre-IND briefing package, post-approval supplements, etc.
Manager/ Senior Manager, Regulatory Affairs - Professional Disposables International, Inc. (PDI)/ Nice-Pak Products
2012 to 2015. Orangeburg, New York
Managed and led Regulatory Affairs team for PDI Healthcare for Pharma/ OTC products and Medical Devices and Cosmetic Products in addition to the responsibilities listed under previous role below. Responsible for the registrations, compliance and regulatory strategies for the NDA, OTC, Medical Device and cosmetic products manufactured by PDI.
Managed all the activities with the newly acquired NDA which included labeling supplements, clinical supplements (PAS), IND submissions and amendments, NDA Annual Reports and IND Annual Reports.
Helped PDI set-up processes to support the NDA. Created about eight SOPs to support Regulatory Affairs functions.
Helped Quality teams achieve GMP compliance. Led the Quality team to set-up a Stability program in-house per ICH guidelines.
Filed a sNDA in December 2012 for a new claim. Have filed and updated an open IND. Have written and filed a 510K premarket notification registration for a new medical device that has been forecasted to increase sales of approximately 20M and on track for market authorization by 4Q14.
Work closely with legal and quality to ensure compliance to SOPs, FDA and EPA regulations. Helped create regulatory databases for a Master List of all products manufactured by PDI/ NP (more than 400 products). Also drove the creation of ingredients database and claims database for the OTC and cosmetic products. Was instrumental in writing, implementing and training on 8 new SOPs and processes.
Senior Regulatory Analyst, Regulatory & Medical Affairs - Roxane Laboratories, Inc.
2007 to 2012 Columbus, Ohio
Managed, authored, reviewed and filed about 20 ANDAs, numerous amendments, supplements and annual reports. Regulatory Lead for all International Third Party projects. Filed and helped approval of five ANDAs involving International Partnerships which was first of its kind for the company.
Filed over 20 ANDAs out of which 6 ANDAs were in eCTD format. Filed over 50 Annual reports out of which about 25 were filed in eCTD format. Have filed numerous supplements/ amendments to the FDA.
Managed 30-40 projects at different stages of development. Provide regulatory guidance on products from development through approval and post approval marketing. Led and drove CMC deficiency meetings to gain approval in a timely manner. Managed, authored, reviewed and filed post approval supplements, CBE-supplements and Annual Reports. Support new product launch meetings by providing regulatory guidance. Provide regulatory assessment of all changes (Change Management Unit (CMU)) related to both new and approved products. Mentored colleagues and direct report on proper regulatory assessment of the CMU changes.
Proficiently used Trackwise and Documentum for assessing and approving changes to analytical methods, specs, and stability reports.
Chemist – QC Launch – Boehringer-Ingelheim Roxane Inc.
2003 to 2007 Columbus, Ohio
Led successful analytical transfer of methods from Germany to Columbus to support a major launch. Supported analytical transfer and testing of nasal products. Always strived for right first time. Never had any investigation caused by personal error during my tenure in the lab. Conducted Gap Analysis on analytical methods before they were transferred over to the QC lab. Supported analytical transfer of an important brand product for the company. Worked on a very low dose solid powder for inhalation product. The technologies acquired during my tenure included Particle Size Distribution and Delivered Dose in addition to HPLC.
Prior to 2003
2001 – 2003 Bigbot Inc.
Manager, Information System Columbus, Ohio
Started as Programmer/Analyst and then as Manager, Information System. Worked with programmers to develop software for the company.
1994 – 1996 Torrent Pharmaceutical Ltd
Scientist, Analytical Development Laboratory, R&D, Ahmedabad, India
Supported analytical testing for development lots produced by Formulation Development group. Worked on raw material testing, finished product testing including but not limited to all oral formulations, topical formulations, injections and cosmetics. Gained expertise on all general laboratory equipment’s including HPLC, GC, FTIR, HPTLC, etc.
Education
Masters in Chemistry: Banaras Hindu University, India
Honors Diploma in Systems Management, NIIT, India
Completed courses in Visual Basic, C++, Java and Oracle form Columbus State Community College