Associate Director/Director, US Advertising/Promotion Regulatory Affairs Vaccines
The Associate Director/Director serves as the regulatory lead on relative Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of biologics.
Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
Work directly with Commercial teams from concept through review and approval, up to and including APLB submission.
Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials
Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines.
Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.
Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
Serve as FDA liaison for matters related to the advertising and promotion of assigned products.
Other Position responsibilities:
Work with other RC team members to provide input into improvement of systems and/or processes.
Provide teams with insight into changes in the regulatory environment, including updates on FDA enforcement letters, meetings, guidance documents, and policies, etc.
Review current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed
Competencies and Capabilities
This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned, as well as for all verbal and written communications with APLB reviewers
The individual will require strong verbal and written communication skills; strong interpersonal skills; good listening skills; strong negotiation skills; demonstrated customer focus and demonstrated ability to facilitate appropriate team decisions.
At least five through seven (5-7) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.