The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices.
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.
Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating and managing business risks.
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.
Must be confident in their analysis and application to impacted materials to ensure compliance with the regulations.
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 OPDP/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 (5) 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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.