| Job Description: |
Specific Responsibilities and skills for Position :
The Manager in Regulatory Affairs, Advertising and Promotions is responsible for providing strategic and operational direction and guidance in the area of advertising and promotion primarily pertaining to US marketing activities within the therapeutic areas of Cardio-Pulmonary and Antiviral drug products under the direction of the Associate Director in Regulatory Affairs. The Manager will review promotional materials to assess for compliance with the promotional regulations and guidance documents. The Manager will provide guidance in the development, review, and approval of promotional materials. Under the direction of the Regulatory Chair at the promotional review committee (PRC), the Manager will attend, participate, and support the regulatory discussion at PRC which includes cross functional partners from Marketing, Medical Affairs, and Legal. The Manager may be in direct contact with the FDA Division of Drug Marketing, Advertising and Communications (DDMAC) for respective products and facilitate the preparation and submission of promotional materials to ensure materials are submitted to FDA in a timely manner. The Manager will represent the advertising and promotion perspective for respective products at the Regulatory Project Team meeting.???
Essential Duties and Job Functions :
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 Manager will also be responsible for reviewing enforcement letters, keeping current with the US regulatory climate, industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and continuing efforts to evaluate processes within regulatory affairs. ??Responsible for preparing and/or overseeing the preparation of technically complex regulatory submissions in line with requirements and scientific and company policies and procedures. May direct others in accomplishing Corporate Objectives. Provides strategic regulatory advice as appropriate. Maintains up to date knowledge of regulatory requirements and communicates 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).?? Requirements Knowledge, Experience and Skills :
Typically requires a BA degree in a relevant discipline, a minimum 8 years of relevant experience in Regulatory Affairs, and at least 1-2 years experience in the review of prescription drug advertising and promotion. An advanced degree is desirable with 6 years of experience. Management experience is desirable. Excellent verbal and written communication skills and interpersonal skills are required. Must have in-depth knowledge of the regulation and regulatory processes pertaining to advertising and promotion. 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. Must be capable of leading a small team in preparation of submissions. 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 particular DDMAC is required. Experience representing Regulatory Affairs on submission teams is mandatory and on Project Teams is desirable.
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