Independent Regulatory Consultant
Large Consumer Pharma Company (Aug 2013 - Current)
Regulatory Strategist – US and Global support.
Mid-Size Pharma Company (July 2013 - current)
Regulatory Reviewer – Advertising and Promotion.
Regulatory Strategist (May 2015- current)
Large Consumer Pharma Company (Oct 2012-May 2013)
Interim Global Regulatory Lead for therapeutic category.
· Provided strategic regulatory input into global programs including new product registrations and current product maintenance activities.
Conducted assessments of risk/benefit scenarios and evaluation of consequences associated with mitigation strategies.
· Regulatory representative at multidisciplinary Global Franchise Team meetings.
· Authored Meeting Requests, Briefing Materials and coordinated meeting preparations activities for FDA meetings.
· Oversaw the regulatory assessment for EU filing strategies (DCP, MRP, NP).
· Regulatory lead on due diligence activities.
· Regulatory strategist for a global product rationalization and license withdrawal program.
· Provided regulatory assessment on device products for the US, Canada and the EU.
· Authored key development and commercialization plan documents for business purposes
Interim Global Regulatory Lead for therapeutic category.
· Provided strategic regulatory input into global programs including new product registrations and current product maintenance activities.
Conducted assessments of risk/benefit scenarios and evaluation of consequences associated with mitigation strategies.
· Regulatory representative at multidisciplinary Global Franchise Team meetings.
· Authored Meeting Requests, Briefing Materials and coordinated meeting preparations activities for FDA meetings.
· Oversaw the regulatory assessment for EU filing strategies (DCP, MRP, NP).
· Regulatory lead on due diligence activities.
· Regulatory strategist for a global product rationalization and license withdrawal program.
· Provided regulatory assessment on device products for the US, Canada and the EU.
· Authored key development and commercialization plan documents for business purposes.
Previous Experience:
Pharmalink Consulting Inc, NJ 08/08-03/13
Senior Director - Regulatory Affairs (12/10-03/13)
Director - Regulatory Affairs (08/08-12/10)
Member of the senior management team playing a key role in the development of the company’s US operation (expansion of team from 4 to 50+). Active in areas of Regulatory Affairs, Project Management, Team Management, Business Development and Operational Management of the US entity.
· Provided regulatory support, including both project management and technical support for numerous regulatory projects including:
· Regulatory strategic planning for two OTC switch initiatives.
· Authored regulatory sections of IND and NDA applications.
· Prepared pediatric plans, DMEPA submissions, labeling strategy documents.
· Project lead in international filing strategy program for a large US based consumer products company.
· Advertising and promotion regulatory strategist for a company’s 4 billion dollar brand.
· Project lead on several CMC programs, including; Change Control initiatives, dossier reconciliation project and generic drug portfolio
expansion program.
· US regulatory strategist for maintenance and line extension strategy for portfolio of established, diversified products.
· Project lead for global product growth program for products purchased through acquisition.
· Operational and management activities include:
· Provided leadership as a member of senior management team; demonstrating success in leading the company through organizational transformation
over 5 years of fast paced growth.
· Recruitment and management of a regulatory team of 25 permanent staff members.
· Business development activities with numerous clients of varying size, including delivery of company presentations, preparing proposals,
negotiation of consulting terms, development of consulting contracts and account manager for several key accounts.
· Development of company policies and procedures.
· Establishment of regulatory affairs multifaceted training program.
· Combined hands on experience with mentoring of teams to motivate a team of professionals to achieve personal and corporate goals.
Pfizer Inc, New York, NY 09/03-07/08
Regulatory Affairs Director (12/06 - 07/08)
Regulatory Affairs Senior Manager (08/04 - 12/06)
Regulatory Affairs Manager (09/03 - 08/04)
· US Regulatory Liaison for several commercial products in the Anti-viral, Anti-infective and Pain Management therapeutic arena; including Celebrex,
Lyrica, Vfend, Eraxis and Viracept.
· Provided strategic regulatory input and contingency plans related to US business decisions on both product and process issues.
· Led the filing of regulatory submissions to the FDA, requiring delegation of project components, timeline management and review of dossier for accuracy
and adherence to requirements.
· Planned and coordinated several product-labeling changes, involving leading a diverse multidisciplinary team, including Marketing, Medical, Safety, Legal,
Manufacturing and Trade groups.
· Reviewed clinical protocols, clinical study reports, clinical supplies labeling and shipping documents.
· Collaborated with CMC colleagues in the preparation of supplements and manufacturing regulatory strategy.
· Oversaw regulatory post-marketing maintenance reporting requirements such as safety reporting and Annual Reports.
· Interacted with various FDA divisions including OPDP/DDMAC through meetings, presentations and phone calls.
· Development of pediatric protocols in compliance with post marketing requirements. Led FDA negotiations on pediatric program.
· Regulatory lead in the planning, preparation, and execution of Pfizer’s presentation at a pediatric Advisory Committee meeting.
· Led the global team in the resolution of a potential stock out situation of a medically important drug that involved coordinating meetings, analytical
thinking and scenario planning to achieve a common business goal.
· Reviewed and critiqued promotional pieces as part of a Review Committee ensuring the compliance of materials with Guidance Documents, enforcement
letters, PhRMA Guiding Principles and corporate standards whilst simultaneously developing a strong, creative commercial message. Actively used
influence and negotiation skills to ensure sound business decisions were made with the recognition of potential regulatory
risks.
· Collaborated with the Marketing and Medical teams on Operational Plans, Plan of Action, launch planning (new product, new indication and
new formulation), press releases, media Q&A documents and strategic business planning for competitor launches.
· Led the team in the review of FDA advisory comments on DTC and professional promotional pieces
· Development of A&P guidance documents for several products. Trained the project team on regulations, current FDA thinking and filing strategy.
· Provided direction and training at conventions and launch meetings, including problem recognition whilst on site and in turn, quick, independent decision
making to resolve potential problems.
· Worked alongside fellow marketing and medical colleagues in the recruitment and training of 40+ field-based colleagues for a new medical initiative.
Merck & Co., Inc., Rahway, NJ. 11/01-9/03
Regulatory Coordinator - Fosamax
· Preparation of IND and NDA submissions for a busy franchise program including filing of an Original NDA.
· Provided regulatory input on Citizen Petition, pediatric and Orphan-Drug initiatives.
Directorate Clinical Pharmacist/Clinical Pharmacist 08/95-1/00
(Several NHS Hospitals)
· Review of medical documentation including patient clinical data, patient literature, protocols and procedures, clinical studies.
· Development of medical documents such as audit forms, assessment forms, training packages, drug expenditure reports, drug
profiles.
· Primary trainer for the junior pharmacists’ clinical program.
· District Project Lead for implementation of the CFC free inhaler program initiative.
Education:
Certificate in Management Studies 03/01-5/03
Baruch College CUNY
Diploma in Clinical Pharmacy (similar to the PharmD program) 08/96-7/98
University of Wales, Cardiff, UK.
Bachelor of Science in Pharmacy (First class honors) 10/92-7/95
Aston University, Birmingham, UK.
Large Consumer Pharma Company (Aug 2013 - Current)
Regulatory Strategist – US and Global support.
- Provide strategic regulatory input into US and Global programs including development of Briefing Materials for FDA meetings.
- Conduct regulatory intelligence research on development programs to assist in the creation of the regulatory strategy and justification of the program’s probability of success.
Mid-Size Pharma Company (July 2013 - current)
Regulatory Reviewer – Advertising and Promotion.
- Review and critique promotional pieces as part of a Promotional Review Committee ensuring the compliance of materials with Guidance Documents, enforcement letters, PhRMA Guiding Principles and corporate standards whilst simultaneously developing a strong, creative commercial message.
- Lead and provide guidance to the team on the submission of draft promotional pieces for review by OPDP, including interaction with FDA reviewers.
- Develop guidelines in support of advertising and promotion initiatives.
Regulatory Strategist (May 2015- current)
- Provide US strategic support for a Global Remediation Labeling Program, including project management of the US arm of the project; assisting in resourcing levels and budgets.
- Provide regulatory advice on labeling proposals for several brands.
- Assessed safety data proposed for implementation into the label.
- Assisted client in interviewing permanent staff members.
Large Consumer Pharma Company (Oct 2012-May 2013)
Interim Global Regulatory Lead for therapeutic category.
· Provided strategic regulatory input into global programs including new product registrations and current product maintenance activities.
Conducted assessments of risk/benefit scenarios and evaluation of consequences associated with mitigation strategies.
· Regulatory representative at multidisciplinary Global Franchise Team meetings.
· Authored Meeting Requests, Briefing Materials and coordinated meeting preparations activities for FDA meetings.
· Oversaw the regulatory assessment for EU filing strategies (DCP, MRP, NP).
· Regulatory lead on due diligence activities.
· Regulatory strategist for a global product rationalization and license withdrawal program.
· Provided regulatory assessment on device products for the US, Canada and the EU.
· Authored key development and commercialization plan documents for business purposes
Interim Global Regulatory Lead for therapeutic category.
· Provided strategic regulatory input into global programs including new product registrations and current product maintenance activities.
Conducted assessments of risk/benefit scenarios and evaluation of consequences associated with mitigation strategies.
· Regulatory representative at multidisciplinary Global Franchise Team meetings.
· Authored Meeting Requests, Briefing Materials and coordinated meeting preparations activities for FDA meetings.
· Oversaw the regulatory assessment for EU filing strategies (DCP, MRP, NP).
· Regulatory lead on due diligence activities.
· Regulatory strategist for a global product rationalization and license withdrawal program.
· Provided regulatory assessment on device products for the US, Canada and the EU.
· Authored key development and commercialization plan documents for business purposes.
Previous Experience:
Pharmalink Consulting Inc, NJ 08/08-03/13
Senior Director - Regulatory Affairs (12/10-03/13)
Director - Regulatory Affairs (08/08-12/10)
Member of the senior management team playing a key role in the development of the company’s US operation (expansion of team from 4 to 50+). Active in areas of Regulatory Affairs, Project Management, Team Management, Business Development and Operational Management of the US entity.
· Provided regulatory support, including both project management and technical support for numerous regulatory projects including:
· Regulatory strategic planning for two OTC switch initiatives.
· Authored regulatory sections of IND and NDA applications.
· Prepared pediatric plans, DMEPA submissions, labeling strategy documents.
· Project lead in international filing strategy program for a large US based consumer products company.
· Advertising and promotion regulatory strategist for a company’s 4 billion dollar brand.
· Project lead on several CMC programs, including; Change Control initiatives, dossier reconciliation project and generic drug portfolio
expansion program.
· US regulatory strategist for maintenance and line extension strategy for portfolio of established, diversified products.
· Project lead for global product growth program for products purchased through acquisition.
· Operational and management activities include:
· Provided leadership as a member of senior management team; demonstrating success in leading the company through organizational transformation
over 5 years of fast paced growth.
· Recruitment and management of a regulatory team of 25 permanent staff members.
· Business development activities with numerous clients of varying size, including delivery of company presentations, preparing proposals,
negotiation of consulting terms, development of consulting contracts and account manager for several key accounts.
· Development of company policies and procedures.
· Establishment of regulatory affairs multifaceted training program.
· Combined hands on experience with mentoring of teams to motivate a team of professionals to achieve personal and corporate goals.
Pfizer Inc, New York, NY 09/03-07/08
Regulatory Affairs Director (12/06 - 07/08)
Regulatory Affairs Senior Manager (08/04 - 12/06)
Regulatory Affairs Manager (09/03 - 08/04)
· US Regulatory Liaison for several commercial products in the Anti-viral, Anti-infective and Pain Management therapeutic arena; including Celebrex,
Lyrica, Vfend, Eraxis and Viracept.
· Provided strategic regulatory input and contingency plans related to US business decisions on both product and process issues.
· Led the filing of regulatory submissions to the FDA, requiring delegation of project components, timeline management and review of dossier for accuracy
and adherence to requirements.
· Planned and coordinated several product-labeling changes, involving leading a diverse multidisciplinary team, including Marketing, Medical, Safety, Legal,
Manufacturing and Trade groups.
· Reviewed clinical protocols, clinical study reports, clinical supplies labeling and shipping documents.
· Collaborated with CMC colleagues in the preparation of supplements and manufacturing regulatory strategy.
· Oversaw regulatory post-marketing maintenance reporting requirements such as safety reporting and Annual Reports.
· Interacted with various FDA divisions including OPDP/DDMAC through meetings, presentations and phone calls.
· Development of pediatric protocols in compliance with post marketing requirements. Led FDA negotiations on pediatric program.
· Regulatory lead in the planning, preparation, and execution of Pfizer’s presentation at a pediatric Advisory Committee meeting.
· Led the global team in the resolution of a potential stock out situation of a medically important drug that involved coordinating meetings, analytical
thinking and scenario planning to achieve a common business goal.
· Reviewed and critiqued promotional pieces as part of a Review Committee ensuring the compliance of materials with Guidance Documents, enforcement
letters, PhRMA Guiding Principles and corporate standards whilst simultaneously developing a strong, creative commercial message. Actively used
influence and negotiation skills to ensure sound business decisions were made with the recognition of potential regulatory
risks.
· Collaborated with the Marketing and Medical teams on Operational Plans, Plan of Action, launch planning (new product, new indication and
new formulation), press releases, media Q&A documents and strategic business planning for competitor launches.
· Led the team in the review of FDA advisory comments on DTC and professional promotional pieces
· Development of A&P guidance documents for several products. Trained the project team on regulations, current FDA thinking and filing strategy.
· Provided direction and training at conventions and launch meetings, including problem recognition whilst on site and in turn, quick, independent decision
making to resolve potential problems.
· Worked alongside fellow marketing and medical colleagues in the recruitment and training of 40+ field-based colleagues for a new medical initiative.
Merck & Co., Inc., Rahway, NJ. 11/01-9/03
Regulatory Coordinator - Fosamax
· Preparation of IND and NDA submissions for a busy franchise program including filing of an Original NDA.
· Provided regulatory input on Citizen Petition, pediatric and Orphan-Drug initiatives.
Directorate Clinical Pharmacist/Clinical Pharmacist 08/95-1/00
(Several NHS Hospitals)
· Review of medical documentation including patient clinical data, patient literature, protocols and procedures, clinical studies.
· Development of medical documents such as audit forms, assessment forms, training packages, drug expenditure reports, drug
profiles.
· Primary trainer for the junior pharmacists’ clinical program.
· District Project Lead for implementation of the CFC free inhaler program initiative.
Education:
Certificate in Management Studies 03/01-5/03
Baruch College CUNY
Diploma in Clinical Pharmacy (similar to the PharmD program) 08/96-7/98
University of Wales, Cardiff, UK.
Bachelor of Science in Pharmacy (First class honors) 10/92-7/95
Aston University, Birmingham, UK.