| Job Description: |
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases.
Gileads primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular and respiratory conditions.
Our portfolio of 13 marketed products includes a number of category firsts and market leaders, including Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) the first single-tablet regimen for HIV infection. Viread (tenofovir disoproxil fumarate), the companys first agent approved for HIV infection, was also approved in 2008 for the treatment of chronic hepatitis B. Chronic hepatitis B, a serious liver disease caused by the hepatitis B virus, is the leading cause of liver cancer worldwide and affects an estimated two million individuals in the United States. Most recently, Cayston (aztreonam for inhalation solution) was granted approval in February 2010 to be used to improve respiratory symptoms in cystic fibrosis patients.
Specific Responsibilities:
The Senior Manager in Regulatory Affairs, Advertising and Promotions is responsible for providing strategic and operational leadership in the area of advertising and promotion primarily pertaining to US marketing activities and products within the therapeutic areas of Cardio-Pulmonary and Hepatitis B under the direction of the Associate Director in Regulatory Affairs. The Senior Manager will review promotional materials to assess for compliance with the promotional regulations and guidance documents. This position will represent the regulatory perspective at promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Legal. The Senior Manager will serve as the company's regulatory liaison to the FDA Division of Drug Marketing, Advertising and Communications (DDMAC) for respective products and ensure materials are submitted to FDA in a timely manner.
This position requires an ability to understand and evaluate competing perspectives and provide clear regulatory guidance. Primary responsibilities include the review and approval of promotional materials for Gilead marketed products. Additionally, responsibilities include characterizing the regulatory promotional perspective and rationale at regulatory project team meetings, and brand team meetings and providing training to product manager counterparts in marketing and members of the PRC. The Senior Manager will also be responsible for reviewing enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and continuing efforts to evaluate processes within regulatory affairs.
Essential Duties and Job Functions:
Responsible for preparing and/or overseeing the preparation of technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. May direct others in accomplishing Corporate Objectives. Responsible for submitting complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications. and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories. Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products. Contributes to the regulatory review of draft Product Company Core Safety Information (CCSI) and ensures updates to the CCDS or CCSI are implemented. Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license. Provides strategic regulatory advice as appropriate. Maintains knowledge of regulatory requirements up to date and communicate changes in regulatory information to project teams and senior management in a timely manner. Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs Department or other departments. Plans, schedules and arranges own activities and those of direct report (if applicable).
To apply, please submit resume through our website at www.gilead.com, Req. #4492. Gilead is an equal opportunity employer. Requirements Knowledge, Experience and Skills:
Typically requires a BA degree in a relevant discipline and minimum 10 years of relevant experience in Regulatory Affairs. An advanced degree is desirable. Management experience is required. Excellent verbal and written communication skills and interpersonal skills are required. Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities. May be required to assume a leadership role in updating and preparing the Company for minor changes in legislation in assigned territories and of actively participating in a broader cross functional team for implementation of major changes. Must be capable of leading a small team in preparation of submissions and maintenance of licenses. Work is performed with no immediate direction from a senior Regulatory Affairs professional. Is recognized as a knowledgeable resource for Regulatory Advice in other departments. Demonstrated ability to act as primary Company contact with Regulatory Authorities. Previous people management experience is desirable. Direct experience working with Regulatory Authorities in assigned territories is required. Experience representing Regulatory Affairs on submission teams is mandatory and on Project Teams is desirable.
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