Sanofi Group Director, Global Regulatory Affairs, US Advertising & Promotion Regulatory Product Support in Cambridge, Massachusetts
In at least one product area of Rare Diseases and Rare Blood Disorders, considered the resident expert in GRA’s US Advertising and Promotion (A&P) group on promotion, labeling, product defense, and development strategies. Is responsible for decision-making, direction, and oversight of the day-to-day activities of their assigned products, departmental activities, and direct reports (if applicable) in order to meet internal and external customer needs. Develops and implements regulatory strategies for marketed products within their product area. Provides input into the global organization for labeling strategies of marketed and pipeline products. Demonstrates significant autonomy in carrying out assigned duties and responsibilities. Directs the activities and professional development of one or more product support colleagues. Liaises with FDA regarding product promotion matters.
This role can either be office based or remote.
Essential Job Duties and Responsibilities:
Makes decisions, provides strategic direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports (if applicable).
In conjunction with the US A&P Therapeutic Area Head, develops effective regulatory strategies regarding product promotion and imparts senior regulatory guidance and advice during issues management activities.
Continually monitors the regulatory environment, interprets new regulations, guidance documents, and enforcement activities/trends and evaluates the impact on the business.
Mentors and develops the professional expertise of US A&P staff in their product areas.
Establishes and develops key internal relationships with therapeutic product leaders in Commercial organization, R&D and Corporate functions (e.g., Communications, Compliance, Legal) to foster open communication and teamwork.
Assures alignment and consistency in US A&P policy application within and across assigned products; takes into account the totality of product-related and company activities.
Establishes and maintains strong relationships with relevant FDA staff.
Performs other duties as assigned.
Bachelor’s degree from an accredited four-year college or university.
Science focus preferred, but not required.
Post-bachelor’s degree from an accredited college or university preferred. but not required.
Job Related Experience:
Experience within pharmaceutical or medical device Regulatory Affairs.
Successful track record with ideally 8-10 years relevant regulatory experience.
Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
Experience managing others preferred.
Knowledge, Skills and Equivalent Experience:
Regularly demonstrates the ability to participate in a more strategic capacity in the functional area and day-to-day decision making process.
Extensive 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
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 and can modify behavior to gain acceptance of ideas or plans.
Can build networks to obtain cooperation without relying on authority.
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values.
Is capable of managing product support projects on topics specific to the functional area. Is able to balance managing these 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 self-manage workload. Is able to multi-task exceptionally well.
Deals with people in an honest and forthright manner representing information and data accurately.
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.
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