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Manager Management

St. Pete Beach, FL, 33706
August 15, 2012

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**** **** ***** *****, **. Pete Beach, FL 33706

862-***-**** - Mobile


Accomplished Regulatory professional with a strong global regulatory, scientific and clinical background in the pharmaceutical development of new molecular entities and life cycle products. Direct regulatory experiences include preclinical, IND/CTA, NDA and post-approval management of brands across therapeutic areas. Successful in negotiating approval of drug applications with FDA and collaborating with co-development and co-marketing partners. Well versed at working with international medical and business leaders to develop well-supported regulatory strategies leveraging corporate goals with global market and regulatory requirements. Strong negotiation and technical writing skills, well-organized, detailed oriented and effective interpersonal and mentoring skills.


September 2003 to September 2011

Genentech / Hoffmann-La Roche, NJ, USA

Director of Regulatory Affairs

(Previously Associate Director, Senior Manager and Manager)


Therapeutic Area Leader/Group Leader: CNS, Oncology and Metabolism Marketed Products

o Provide regulatory strategic leadership for products within the therapeutic area portfolio

o Supervise regulatory affairs staff: Provide strategy, guidance and mentorship of staff during the management of global health authority interactions and critical issue management of products

o Serve as global regulatory lead on life cycle products - provide continuous support to the global maintenance of licenses including critical issue management

o Ensure that regulatory strategic options are aligned cross-functionally

o Manage day-to-day compliance issues by ensuring adherence to GCP requirements

o Participate in career growth and personal development of employees

o Participate in the development, review and approval of corporate communications including press releases, Pharma Partnering, corporate PR and investor relation materials

o Coordinate the development, corporate endorsement of US and Global Dear Healthcare Provider Letters by Roche’s Chief Medical Officer

o Subject matter expert and local trainer of regulatory strategic thinking

o Ensure business needs are met by managing resource allocation and talent requirements

o Establish and maintain collaborations with global Business, Medical, Legal and Safety functions

o Manage co-development/marketing partnerships for products within the therapeutic areas

Key Country Partner (KCP) for Emerging Markets (E7): Oncology Therapeutic Area

o Provided E7 regulatory strategic leadership for a business critical Life Cycle Oncology project

o Established and chaired Key Country regulatory functional teams

o Developed E7 strategies in line with Roche Business and regional environmental requirements

o Strategized and coordinated regional regulatory submissions to support clinical trials

o Served as lead interface (in collaboration with the Affiliates) in E7 health authority meetings

o Coordinated strategies across Pharma Development and Pharma Technical

o Led and participated in the development of process maps outlining E7 requirements to support clinical trial applications and preparation of dossiers – specifically, clinical data and CMC requirements to support local applications

o Ensured allocation of proper resources for E7 driven regulatory activities

Global Regulatory Leader (GRL): Metabolism Therapeutic Area

o Provided global leadership in the development and implementation of global strategies – balancing time, costs, quality and risks

o Worked closely with global functions (Medical Affairs, Business and Safety) to align cross-functional expertise required to drive global regulatory strategies

o Worked with planning and finance to secure adequate resources to meet business objectives

o Led business critical global process initiatives

o Led complex critical issue management

o Chaired global regulatory functional teams

o Lead the interface with health authorities

o Represented Roche regulatory when collaborating with Alliance Partners

US Regional Partner: CNS, Metabolism, Virology and Cardiovascular Therapeutic Areas

o Provided US strategic direction to cross-functional global R&D and US product teams of pre-Life Cycle compounds (pre-/ Phase 1 and 2 projects)

o Developed regulatory strategies, provided direction on health authority interactions and prepared regulatory submissions

o Represented Roche as lead interface with FDA

o Developed regulatory risk management and contingency plans

o Worked with functional management to ensure US regulatory team had appropriate budget and resources to meet objectives

o Chaired local regulatory sub-teams

o Supported Roche’s Pharma Licensing group in Due Diligence expeditions

o Mentored PDR personnel and assisted in the development of people in fellowship programs rotating through Regulatory

Key Accomplishments:

Contributed to a successful undertaking of global roles by US Managers of Marketed Products

Business Process Owner of a corporate cross-functional initiative to develop, roll-out and conduct training of a guideline for the management of global critical safety issues

Developed Global and US guideline on development, internal review and approval of DHCP Letters – act as the single conduit to the Head of US Medical Affairs, Global Head of Safety & Pharmacovigilance and Roche’s Chief Medical Officer

Developed Global guideline on development, internal review and approval of Dear Investigator Letters

Active participation in a Global Training Group - providing continuous assessment of global training needs and delivering training of Regulatory Strategic Thinking to regulatory personnel

Contributed to a successful establishment of Roche Pharma’s E7 (Emerging Markets) Initiative within Regulatory Affairs

Submitted and gained approval of a US NDA for Boniva (ibandronate sodium) – expansion of product use into the prevention of postmenopausal osteoporosis

Key participant in the development of an IND Best Practices Guidance Document

July 2001 to August 2003

Pfizer Corporation / Pharmacia, Chicago, USA

Regulatory Affairs Manager


Supported the US Regulatory Team in seeking line extensions within the COX-2 franchise

Demonstrated leadership for compliance with global regulations around investigational compounds in the arthritis and inflammation therapeutic area

Formed part of a R&D team who collaborated with FDA to pioneer the concept of micro-dosing

Assisted in the development of global regulatory strategies and negotiated data requirements and documentation with product development functions and regulatory agencies

Prepared clinical trial applications and marketing authorizations for ex-US regulatory agencies

Acted as liaison with the US FDA

Coordinated the collection of data to respond to queries from US and other regulatory agencies

March 2000 to June 2001

Abbott Laboratories, Chicago, USA

Regulatory Associate


Responsible for the registration of pharmaceutical, hospital, device and nutritional products into international markets including Latin America, Europe and Pacific/Asia/African countries

Represented International Regulatory Affairs at cross- divisional R&D meetings and presented International regulatory requirements

Authored core registration packages in line with global regulatory requirements and local guidelines

Responded to evolving market conditions by addressing deficiency questions originating from Health Authorities regarding product manufacture, packaging, storage, world market and ongoing research

April 1999 to February 2000

Caremark Therapeutic Services, Chicago, USA

Admissions Coordinator


Responsible for researching insurance coverage on patients referred to Caremark by physicians requesting Growth Hormone, Hemophilia, IGIV, Multiple Sclerosis, Synagis, and other therapies prior to the initiation of treatment.

Pursued alternative options for benefits excluded from the insurance plan. Communicated with Admissions Management staff, Physicians, Patients, Payers, District Manager, Managed Care, and Branch Manager on the status and outcomes of referrals.

Initiated and verified drug quantities to be dispensed by pharmacy branches

August 1998 to March 1999

United Behavioral Health, Chicago, USA

Intake Coordinator


Responsible for collecting demographic information from patients and healthcare providers

Analyzed types of mental health and/or chemical dependency services requested by patients and coordinated appropriate level of care

Liaised coverage information to patients and physicians ranging from benefits and eligibility, to provider credentials and level of services offered at specific facilities belonging to the insurance network


Mini MBA: BioPharma Innovation Program (2008)

Rutgers University (New Jersey, USA)

Graduate School (1998)

Rosalind Franklin University of Medicine and Science (Chicago, USA)

B.Sc. Biology with Biochemistry Specialization/Pre-Medicine (1997)

Illinois Institute of Technology (Chicago, USA)


Essential Facilitation - Interaction Associates

Regulatory Strategic Thinking

Effective Marketing in a Regulated Environment

Effective Communications

The Successful Negotiator - Asherman Associates

Leadership - Frank Lee

Line Management Development Pathway


Drug Information Association (DIA)

Regulatory Affairs Professional Society (RAPS)


Bilingual: English and Spanish

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