Summary High-energy, results-oriented and problem-solver R&D Senior Scientist/Project Leader with extensive experience in product development, project management, regulatory submission, outsourcing, compliance, and quality assurance. Decisive leader with a proven track record in fast-paced, highly competitive environment, a passion for innovation and teamwork that delivers successful solutions to complex projects and drives growth, productivity and reduced costs. Experienced and Knowledge of drug discovery, drug development, clinical/pre-clinical studies and commercial manufacturing processes. Experience in:
- Rx, Rx-to-OTC switch, and OTC products
- IND/CTX/IMPD, CTD/NDA/MAA & ANDA
- Lean Six Sigma and OE Certifications
- FDA, EMEA, CTA and Japanese agency
- Solid, Semisolid, and Medical Devices
- cGMP, Compliance, CAPA, Trackwise, Quality Improvement
Confidential, Roseland, NJ 07/2009-Present Sr. Regulatory CMC Specialist-Global Regulatory Affairs Department
- Managing regulatory projects, coordinating regulatory related activities and providing regulatory supports.
- Preparing regulatory documents for filling of IND, NADA/NDA/sNDA and addressing regulatory findings.
- Preparing and reviewing regulatory change control, responses for post-approval and annual reports.
- Preparing and updating CMC documents for FDA and EMEA submission and rest of world submission.
- Preparing post approval document, regulatory strategy for project and addressing quality resulted issues.
- Liaison with product development, quality and marketing to provide a consultation for regulatory strategy.
- Reviewing, archiving and maintaining regulatory related documents and communicate in the department.
- Evaluating post approval, pre-approval a changes to ensure it is inline with agency guidelines and impact for regulatory filling. Preparing different variation related regulatory documents for regulatory submission.
Confidential, Parsippany, NJ 07/2001 - 07/2009 Project Leader/Senior R&D Development Scientist-New Product Development Department Successfully led and managed development projects from concept to commercial launch in global market, including leading and managing outsourcing, technology transfer, regulatory and clinical study related activities.
- Successfully led, managed and launched multiple projects; e.g., cold sore, medical devices, weight-loss and Rx-to-OTC switch. Successfully led and managed first time regulatory submission with all EU countries.
- Drove for product approval with regulatory agency (FDA, EMEA, MHRA, CTX and other agency) by providing support for post approval, CMC documents, addressing deficiency and presenting technical information.
- Collaborated, negotiated, and communicated with internal and external partners for achieving project goals.
- Successfully coordinated and prepared regulatory responses related to regulatory findings to different agencies
- Developed and designed product specification and CMC documents for IND/NDA/sNDA using CTD format.
- Coordinated and prepared the dossier change request and site transfer documents for different regulatory agencies.
- Successfully prepared and delivered project planning outlines, milestones and facilitated project teams’ activities.
- Led and managed all cross functional teams activities including coordinating analytical and formulation development activities, regulatory strategy, clinical strategy, and technology transfer to manufacturing site.
- Coordinated, developed, validated and transferred analytical methods for drug substances, finished products (cold sore, medical devices, analgesic, and weight-loss products) and inactive materials.
- Implemented global outsourcing stability in India/Europe and saved & gt;65% of operating cost.
- Successfully led and transferred analytical methods and technologies with CRO and outsourcing company.
- Negotiated and implemented service contracts with CRO and outsourcing companies and reduced 40% of costs.
- Improved efficiency and productivity by reducing investigation, CAPA, deviation and safety issues for the site.
- Set up the first platform for in vitro release testing for cream and lotion products using human tissue and improved new prototype screening for formulation selection and clinical study assessment.
- Collaborated with internal and external experts for material characterization and improved productivity.
- Completed six sigma and OE (QbD) certifications and improved lab practices, resulting in 30% reduction in operation costs.
Confidential, Morris Plains, NJ 02/1996 - 06/2001 Team Leader- Analytical Research & Development Department Successfully led, managed and delivered multiples projects for product development, method development, validation, method transfer and saved troubled projects by resolving technical issues for products and accelerated regulatory approval of IND/NDA of >$1 billion of market share products.
- Devised high priority methods development for crucial products and resolved critical technical issues.
- Accelerated IND/NDA regulatory approvals and post approval for multiple Rx and OTC products by providing support for technical documents and addressing stability, technical, and regulatory deficiency.
- Collaborated with FDA, internal and external consultants to successfully close consent decree.
- Successfully coordinated and provided responses related to technical questions to different regulatory agencies
- Developed and designed product specification and CMC section-technical documents for IND/NDA/sNDA.
- Accelerated product development and technology transfer by resolving GMP and process validation issues.
- Successfully led and transferred analytical methods with various sites and streamlined the practices.
- Streamlined documentation practices, implemented new documental practices and saved & gt;$0.5MM annually.
Confidential, Dayton, NJ 06/1995 - 02/1996 Manager - Analytical Research and Development Department Led and managed R&D team for method development, validation and technology programs including coaching, training and monitoring analysts for technical skills and maintained safety and compliance requirements for the department.
- Streamlined method development, validation and method transfer for ANDA submission with measurable reduction in time and cost.
- Defined and implemented material characterization technology, which led to differentiating out the products from brand (Rx) and other competitors.
- Adhered to all compliance mandates with appropriate regulatory guidelines and standard operating procedures by validating and correcting relevant cGMP documentation.
- Improved efficiency and productivity for product development by implementing close collaboration with various groups including issuing technical documents for regulatory submission and training multi functional groups.
Confidential, Northvale, NJ 04/1992 - 06/1995 Research Fellow /Group Leader-Research and Development Department Developed and validated analytical methods, implemented new technologies, and improved productivity, compliance and safety. Successfully developed, validated and transferred the analytical methods and resolved complex technical problems for submission.
Confidential, East Hanover, NJ 09/1990 - 04/1992 Analytical Quality Control Chemist Analyzed API and finished products and maintained equipment integrity by assuring proper IQ/OQ/PQ and calibrations.
Education and Professional Development Doctor of Philosophy (Ph. D.), Analytical Chemistry Master of Business Administration (MBA) in Pharmaceutical-Chemical Studies Master of Science (MS), Organic Chemistry Bachelor of Science (BS), Chemistry
- Six Sigma and Operation Excellence Certification by GSK CHRD (2008)
- Global Strategic Project Management by Advanced Leadership Group (2004)
- Effective Leadership and Managing Projects by Advanced Leadership Group (2002)
- Advanced Presentations Skills by Advanced Leadership Group (2006)
- Effective Decision Making by HDC Consulting (2002)
- Advanced Method Development and Separation by LC/MS, Pittcon Conference (2005)
- The 7 Habits of Highly Effective People by Franklin Covey Co. (2002)