Current Statistics
1,533,794 Total Jobs 434,237 Jobs Today 17,282 Cities 222,692 Job Seekers 146,722 Resumes |
|
|
|
|
|
|
Associate Director, US Advertising and Promotion, Global Regulatory Affairs - Bridgewater New Jersey
Company: Sanofi Location: Bridgewater, New Jersey
Posted On: 04/20/2024
About the RoleThe Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio. 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 prescription drugs and biologics. Essential Functions - - - - - Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of US advertising, promotion, disease-state, market access, and press materials. Submits materials on form FDA 2253 when applicable.
- Provides US RA AdPromo strategic guidance and subject matter expertise for responsible investigational and marketed products, to meet both short- and long-term business objectives while mitigating risk. Consults with senior management and provides input to the global organization as needed.
- Contributes US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications.
- Primary Liaison with OPDP/APLB and effectively manages relationships with FDA contacts. Establishes and maintains strong collaborative relationships with Regulatory and other R&D colleagues, as well as other stakeholders (e.g., Legal, Medical, Marketing, Communications and Compliance).
- 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.
- Participates in the development, monitoring and updating of standards and processes related to drug, device, and biologics US AdPromo regulations and guidances.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
- Significant understanding of the U.S. pharmaceutical marketplace, especially the rules and regulations related to the promotion of prescription drugs in the Uniteed States
- 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. - - - - - - - -Minimum Requirements:Educational Background:
- Bachelor's degree from an accredited four-year college or university (Area of specialization: Life Sciences)Job-Related Experience:
|
|
|
|
|
|
|
Copyright 2024 LocalJobBoard.com. All Rights Reserved.
RSS Job Feeds
Associate Director, US Advertising and Promotion, Global Regulatory Affairs: Bridgewater, New Jersey job search information from LocalJobBoard.com
Recruiter expertise by Recruiter Media Corporation
Job Offers Search Engine
Bridgewater New Jersey job: Associate Director, US Advertising and Promotion, Global Regulatory Affairs, Bridgewater New Jersey job search
|