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Job Field: Office Jobs
Location: United States, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00408240Job114of363Associate Program Manager, Commercial Regulatory AffairsSouth San Francisco, CaliforniaJob factsJob functionClinical Regulatory AffairsLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionAssociate Program Manager, Commercial Regulatory Affairs (CORA)Job Purpose:CORA is part of the broader Product Development Regulatory Affairs (PDR) organization. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. CORA Associate Program Managers support Promotional Review Committees (PRCs) and CORA Program Directors by reviewing labeling, promotional, advertising and education materials produced for marketed products in compliance with governing laws, regulations, and Standard Operating Procedures (SOPs) in a manner that supports Roche business objectives. This position is considered entry-level for CORA and, as such, Associate Program Managers perform their responsibilities with considerable supervision. Primary Responsibilities:* Expected to develop and maintain his/her knowledge base of laws, regulations and guidelines governing the marketing of drugs and biologics * Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices * Maintains current awareness of evolving health authority interpretations; including advisory letters, enforcement letters and policy issues* Participates in the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from health authorities and Roche policies * Provides regulatory input on concepts and draft materials * Participates in development and implementation of effective strategies for health authority marketing, advertising and communications submissions * Assists the PRC chairperson with development of relevant correspondence to health authorities and interpretation of health authority comments* Researches and benchmarks topics and competitor materials prior to PRC meetings. Creates and maintains safety/claims binders * Supports CORA PRC Chairs and PRCs by reviewing and ensuring that content, quality, accuracy and formatting of regulatory submissions comply with applicable laws and regulations, which may involve collaboration with cross-functional internal groups and external advertising agencies * Partners with other PDR staff, CORA Program Directors and PRC members to ensure PRC meetings run smoothly; includes assisting CORA Program Directors, as needed, in scheduling, conducting, and managing follow-up from PRC meetings * Ensures changes to labeling, promotional, advertising and/or educational materials are consistent with PRC recommendations. Performs final proof and issues final approvals of materials * Serves as a primary contact for Marketing to resolve issues related to labeling, promotional, advertising, education or other relevant materials under review, revision or reorder. As needed, consults with CORA Program Directors Supports formal and informal training tools and activities pertaining to advert

KEY REQUIREMENTS:

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