Drug Development Regulatory Affairs Expert
Technical Consultant #2306
- Full spectrum of drug development; (pre-IND to marketed products) and development of multiple pharmaceutical products.
- Global regulatory challenges in drug development and handling a wide range of drug development.
- Regulatory strategy and CMC strategy.
- Gap analysis and review of the CMC package.
- IND and pre-IND submissions.
- Pre-IN, IND, (Investigation New Drug), CTA, (Clinical Trial Approvals), IMPD, (Investigational Medicinal Product Dossier), NDA (New Drug Application) and MAA (Marketing Authorization Applications) submissions.
- Due diligence.
- FDA and MAA meeting package preparation and strategy.
- Contract manufacturer, contract lab oversight, and management.
Independent Contracting, Regulatory CMC Consultant, Present
- Regulatory professional with 20 years of direct and first-hand global regulatory experience in both large pharmaceutical and small biotech companies located in the U.S.A. and Europe.
- The experience encompasses the full spectrum of drug-development expertise (pre-IND to marketed products) and has been involved in the development of multiple pharmaceutical products.
- Managed the global regulatory challenges associated in drug development and has gained experience in handling a wide range of drug development issues.
Syner-G Pharm Consulting, Burbank, CA, Sr. Director, Regulatory Affairs, 2014 - 2016
- Part of the senior management of the company handling the clients and business development in the West Coast.
- Sr. Regulatory Affairs CMC adviser for clients in various stage of development meaning from first in human (pre-IND) to post approval phase.
- Assisted companies with their FDA meetings and deficiency letters, gap analysis of the NDA and INDs, due diligence activities, producing pharmaceutical development plan for the clients encompassing all the stages of the development to approval, (NDA), writing and reviewing key sections of the NDA, DMF, briefing packages, and other tasks.
- Led and mentored a team of senior and junior consultants; provided guidance and strategic advice regarding the regulatory issues they were handling for their clients.
- Produced educational seminars for the company and junior people and AAPS posters.
Puma Biotechnology, Los Angeles, CA, Sr. Director, Regulatory Affairs, 2011 - 2014
- Global Regulatory CMC lead for Neratinib accountable for all regulatory CMC related deliverables and activities.
- Provides strategic Regulatory guidance and advice to the CMC team and the contract manufacturers with regard to Neratinib's pharmaceutical development plan and various CMC, quality, and manufacturing issues.
- Involved in the producing CTM labeling and CTM supply for several global studies.
- Responsible for the content and strategy with regard to quality (Module 2.3 & 3) sections of the NDA and MAA and production of the IMPD.
- Arranged and involved in FDA Type B and C CMC meetings.
- Global Regulatory lead for a few global clinical studies. Provided strategic regulatory guidance and advice to the clinical study teams in terms of study design, strategy, and protocol reviews.
- Contact point for the non-clinical data of the product and work with external experts in in reviewing, assessing and generating non-clinical data needed for Regulatory purposes and the content of Module 4.
- Budgeting, forecasting and also supervising Associate Director of Regulatory Affairs.
Cougar Biotechnology/JnJ,, Los Angles, CA, Director, Regulatory Affairs, 2007 - 2011
- Regulatory CMC lead for Cougar's main drug candidate Zytiga® (abiraterone acetate) which led to approval of Zytiga in U.S. Europe, Canadian and APAC countries. This provided strategic regulatory guidance and advice to the CMC team and the contract manufacturers with regard to Neratinib's pharmaceutical development plan.
- Arranged and involved in FDA EOP2 and Pre-NDA CMC meetings and pre-MAA CMC meetings with the Rapporteurs.
- Global Regulatory lead for one developmental oncology drug (Noscapine). Provides the project team guidance on clinical, preclinical and formulation development activities. The main contact point for agency communication.
- Project manager for the noscapine project, managing the team and its deliverables. Provides strategy for product development to the senior management.
- Budgeting, forecasting and also supervising Sr. Manager of Regulatory Affairs.
Abraxis BioScience, Santa Monica, CA, Senior Regulatory Affairs Scientist, 2005 - 2007
- Involved in the compilation and submissions of Abraxane® MAA in eCTD (Electronic Common Technical Document) format to Europe and NDA (New Drug Applications) in Australia and Canada.
- Regulatory Lead for three oncology products under the IND. Successfully complied and managed the pre-IND meeting packages with FDA with "May Proceed" letters.
- Regulatory Lead for 3 marketed products. Managing the post marketing submissions (e.g., CBE, PAS, labeling supplements, annual reports, etc).
- Managing the compilation of the Japanese NDA and the pre-NDA meetings.
- Global Labeling person for all the labeling changes to the prescribing information and Core Data Sheet.
Amgen, Thousand Oaks, CA, Global Labeling Liaison, 2004 - 2005
- Responsible person for the labeling of Amgen's high-profile oncology products (Aranesp, Neulasta, Neupogen and Kepivance) world-wide.
- Managed the review, creation and maintenance of the CDS for the existing products and also for the new products in the pipe-line.
- Managed the review, creation and maintenance of the labels for the oncology products and helped with labeling submissions.
- The review process included creation of the background documentation for the label review for the senior management, provide rationale for the changes, obtain consensus and complete the formal approval process.
- Involved in the labeling negotiation with the authorities world-wide.
Abbott Laboratories, North Chicago, IL, Global Regulatory Head, 2002 - 2004
- Global Regulatory Head for Abbott's cardiovascular franchise products. These products were approved in over 70 countries.
- Responsible for the Global Regulatory Plan for the cardiovascular products.
- Represented Regulatory Department in the project team meetings, meeting with senior management, including agency meetings.
- Managed the documentation team who compiled, authored and reviewed the regulatory dossiers.
- Managed the introduction of new dosage forms of the products in countries (U.S. and Europe).
- Managed the label expansion (new indication) for the products.
- Managing two direct reports.
Fresenius-Kabi,, Sweden, International Regulatory Manager, 1998 - 2002
- Global Regulatory lead for company's award-winning products.
- Managed the first approval of the two novel products in over 35 countries including Europe.
- Managed the compiling, writing and reviewing of the Regulatory dossiers.
- Responsible for the Global Regulatory Plan for my products. Represented Regulatory Department in the project team meetings, meeting with senior management, and at agency meetings.
- Helping the U.S. office to put together the NDA for the new products.
Medical Product Agency, Uppsala, Sweden, CMC Reviewer, 1997 - 1998
- The CMC reviewer for both biologics and drugs.
- Handled the review of new formulations, abridged application, generic application, variations (supplements) and, application for the parallel import.
- Responsible for creating the assessment report and provide a summary of the review to the senior management including a decision about approval/rejection of the application.
- A member of the review group of the product at the agency that was involved in contacts with applicants (sponsors).
Pharmacokineticer, Pharmacia and Upjohn, Sweden, 1996 - 1997
- Worked at the Clinical Pharmacology department and worked as pharmacokineticer for the products in the clinical trials.
Uppsala University, Uppsala, Sweden, Research Associate, 1996 - 1997
- Worked with a research group within the institution for Biopharmacy and Pharmacokinetic and was involved in a research project sponsored by FDA and MPA.
Honors & Publications
- Certification: Regulatory Affairs Certification - RAC
- Food and Drug Law, Temple University
Academic and Professional Affiliations
- American Association of Pharmaceutical Scientists - AAPS
- Regulatory Affairs Certification - RAC
- M.S. Pharmacy, Uppsala University Pharmacy School, Uppsala, Sweden