Job title: Manager Regulatory Affairs Advertising and Promotion
- Location: Cambridge, MA / Morristown, NJ
Main Responsibilities:- Identifies product-specific or therapeutic area A&P issues and works with other teams to propose and implement solutions.
- Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.
- Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.
- Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
- Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs.
- Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications.
- Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
- Performs other duties as assigned.
About YouBasic Qualifications:
- Bachelor's degree from an accredited four-year college or university; Science focus preferred, but not require
Work Experience Required:
- 1+ Years experience in the following areas:
- Experience within pharmaceutical or medical device Regulatory Affairs.
- Successful track record with ideally 1-3 years relevant regulatory experience.
- Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
- Experience in Advertising and Promotion in Regulatory required.
- Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
Knowledge, Skills and Equivalent Experience:
- Knowledge and understanding of complex medical and scientific subject matter.
- Ability to work well within cross-functional teams.
- Demonstrates solid oral communication and writing skills.
- Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.
- Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
- Develops collaborative relationships to facilitate the accomplishment of work goals.
- Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
- Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
- Can build collaborative internal networks to obtain cooperation.
- Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.
- Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
- Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well.
- Deals with people in an honest and forthright manner representing information and data accurately.
The salary range for this position is:
$122,250.00 - $176,583.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
