Sanofi Group Manager/Sr. Manager Regulatory Advertising & Promotion Product Support in Cambridge, Massachusetts
Under the direction of the Sr. Director, this individual will be responsible for providing US regulatory advertising and promotion support for MS/Rare Disease/Rare Blood Disorder products. Additionally, and under the direction of individual’s supervisor, the Manager/Sr. Manager will conduct the review of promotional and other product and disease-related materials and develop and implement regulatory strategies related to promotion and advertising campaigns.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Functions as the product Advertising & Promotion expert for assigned products
Represent US regulatory as a member of cross functional brand team review committees, providing regulatory input into the review of advertising, promotion, medical and press materials.
In support of brand teams, provides proactive promotional strategies and tactics so that the company can meet both short- and long-term growth targets
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
Effectively manages relationships with FDA contacts; establishes and maintains strong collaborative relationships with Regulatory and other R&D colleagues, as well as other functions (e.g., Legal, Medical, Marketing, Compliance)
Primary liaison with OPDP or APLB for assigned products.
Consults with senior management to develop and communicate regulatory strategies and opinions for products and projects.
Participate in the development, monitoring and updating of standards and processes related to drug, device, and biologics regulations.
Job Related Experience
Experience within pharmaceutical and/or medical device Regulatory Affairs
Successful track record with ideally 1-5 years relevant regulatory experience.
Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
The company reserves the right to consider candidates not possessing these minimum requirements but who possess an equivalent combination of comparable education and experience. Internal Career Development candidates are one example where minimum educational and job experience requirements may be not be applicable.
KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE
Knowledge and understanding of complex medical and scientific subject matter.
Ability to work well within cross-functional teams.
Can demonstrate solid oral communication and writing skills.
Understanding of the U.S. pharmaceutical market place, 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.
In conjunction with the therapeutic area leader, generates 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 networks to obtain cooperation.
Unquestionable ethics, professional integrity and personal values consistent with the sanofi-aventis 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.
Bachelor’s degree from an accredited four-year college or university - Area of specialization: Life Sciences
Doctorate degree from an accredited college or university (e.g., M.D., J.D.,PhD, PharmD, or equivalent) preferred but not required
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.