Anne M. Marra

732-***-**** Greater New York Area acuhj9@r.postjobfree.com

A Pharmaceutical Professional with extensive experience creating forward thinking processes

and systems and leading high-profile enterprise-wide projects at Fortune 500/100 companies to deliver

high-quality, highly recognized and on-time product submissions to the authorities. Recognized by senior management to possess the ability to analyze complex situations, develop solutions, lead projects and cross-functional teams to deliver superior results. Highly proficient in planning, organization, recognized as an effective team builder, facilitating projects at all levels through influence and expert knowledge of subject matter.

PROFESSIONAL EXPERIENCE

Radius Health Executive Director, Regulatory Operations & Program Management 2015-Present

Directing the daily operations of the Regulatory Operations organization and be aligned to the global operating model and oversee the planning and execution of regulatory submissions.

Directed and implemented the successful filing of the MAA and NDA for the company’s flagship product for osteoporosis, a significant healthcare need.

Ensured excellence in the global regulatory support of project/products from inception through to end of lifecycle management.

Executive Director, Regulatory Affairs & Program Management 2014-2015

Oversight and direction of all Regulatory Affairs for a fledgling company

Instituted author style guide, initiated global templates for eCTD submissions, created awareness and began setting the stage for electronic filing of the company’s future submissions.

Successfully filed the first two INDs in an eCTD format for the Radius Oncology and Vasomotor program.

Teva Pharmaceuticals Senior Director & Global Head, Regulatory Operations 2010-2014

Brought in to design and lead the enterprise-wide effort to modernize, globalize and harmonize 5 regulatory systems into a singular Global Regulatory Filing Development Process.

Directed all activities of Global Regulatory Operations including strategy, budget, direct reports, vendors and contractors to ensure effective and efficient usage of resources.

Spearheaded global regulatory submission teams and projects relating to eCTD requirements, submission guidances and relevant technology.

Oversight of linking of cross-functional teams with Regulatory Affairs management and technical disciplines (Medical Writing, CMC, IT, QA) to accomplishing global submission goals.

Educated senior management, department heads and the authoring community on eCTD requirements, submission processes, best practices and Electronic Data Management Systems.

Drove systems development and led eCTD and electronic submission consulting to multiple business units.

NPS Pharmaceuticals Inc. Senior Director, Regulatory Affairs/Operations 2006-2010

Recruited to direct and oversee the Regulatory Affairs/Operations efforts in the preparation, coordination, and submission of Regulatory documents.

Oversaw policy review, implementation of technical regulatory activity, maintenance of existing/future paper and electronic archives, preparing agency meeting presentations, provided support for Health

Authority meetings, budgeting, staffing and management of outside contractors.

Led efforts to develop the integration of Documentum and FortDocs to result in an integrated system.

Developed a set of processes that supported the standardization of a common pool of documents for use across the R&D organizations and exceeded project objectives within four months of project initiation.

Co-chaired a multi-functional member task force to develop a new business model, transitioning the

company to a virtual organization, achieving completion within one year of project initiation.

Imclone Systems Senior Director of Regulatory Affairs/Operations 2004-2006

Directed and led the Regulatory Affairs/Operations efforts in the preparation, submission, and archiving of all regulatory submissions.

Directed and led the Regulatory Operations team to successfully deliver major submissions to the FDA on time and of high quality (Erbituxâ Head and Neck Squamous Cell Carcinoma sBLA and two INDs).

Directed the analysis, management approval, and selection of the FirstDocs program enhancing the utility of the existing Documentum system resulting in an integrated system and set of processes supporting company standards.

Directed the development and implementation of a standardized approval process for regulatory submissions for Imclone, providing timelines and sequencing of activities to guide authors/assemblers to ensure on time submissions to regulatory authorities.

Standardized the templates within the authoring community using ISIWriter resulting in a unified appearance and format, which facilitates the publishing process.

Watson Pharmaceuticals Inc. Director of Regulatory Affairs/Operations 2003-2004

Directed the technical preparation, submission and archiving of all regulatory submissions; including all post-approval submissions for generics and pre- and post-approval submissions for branded products.

Oversaw a staff of 23 across five U.S. sites with levels ranging from Associate Director to Manager to Regulatory Associates. Reported to the Vice President, Regulatory Affairs/Operations.

Directed and led company-wide cross-functional process improvement efforts, resulting in establishment of new procedures for communications with health authorities.

Led cross-functional committee to re-engineer review of product promotional materials, resulting in new standards and review processes ensuring regulatory/legal compliance of promotional materials.

Johnson & Johnson Associate Director, Global Regulatory Affairs 2001-2003

Drove the management, planning and delivery of regulatory submissions to support the development and registration of new products, ensuring effective and efficient delivery of on time submissions.

Oversight of the company’s largest and most important product, PROCRITâ (epoetin alfa) and concurrently managed the joint-venture projects with ALZA.

Oversaw actions of the Global Dossier Team and directed the creation of the Dossier Plan, ensuring that issues, conflicts, and deviations from the plan were identified, communicated and resolved to support efficient decision-making and forward momentum.

Pharmacia (now Pfizer) Global Regulatory Operations Manager 1998-2001

Responsible for overseeing activities relevant to the development and implementation of information systems resulting in electronic submissions for major U.S. and international regulatory strategies.

Oversaw program to execute the rollout of WISDOM (Documentum), which included plan development and execution of implementation plan for set-up and training of various levels within the company (senior and middle management as well as line personnel).

Orchestrated and led effort to analyze and develop a document management process at the Stockholm Regulatory office, resulting in improved document readiness for electronic submissions at that site.

Upjohn (now Pfizer) Dossier Management, Regulatory Affairs 1984-1998 Responsible for managing the regulatory document processes for the assembly, publishing, and submission of worldwide and U.S. dossiers as directed by Global Business Management.

Led several Dossier Preparation Teams (FREEDOXâ for the indications of subarachnoid hemorrhage, renal cytoprotection, and surgical adhesions) for filing in the European Union and the U.S. [FDA] in April of 1998.

Led the Dossier Preparation Teams in the development of the regulatory file for Detrolâ, Cleocin Ovuleâ, and PNU142731 (asthma), resulting in the successful assembly and on time submission to regulatory authorities.

Coordinated and worked in conjunction with Regulatory Management in the U.S. Market Company on the development and timely delivery of the dossier for the NDA submission of Detrolâ (tolterodine).

Participated in the accelerated preparation of several INDs/NDAs for timely submission to FDA to meet target year-end deadlines for 1996 and 1997.

Contributed to the creation and development of a new unit and position (Regulatory Document Manager Dossier Specialist) through joint membership and leading of Process Improvement Teams, resulting in a centralized coordination function to oversee successful regulatory filing efforts.

ORGANIZATIONS/ACCOMPLISHMENTS

Member of the Drug Information Association (DIA).

Member or International Institute of Research (IIR).

DIA and IIR Speaker and Faculty - strategies and tactics for developing the e-submission.

EDUCATION

B.A., Business and Management of Human Resources with honors, Spring Arbor College.

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