Job title: Senior Director Global Regulatory Affairs, Advertising & Promotion
Job description: JOB SUMMARY
In one or more therapeutic areas, considered a resident expert in GRA on US advertising, promotion, labeling, product defense, and related activities and strategies. Contributes to the maintenance and enhancement of strategic relationships with customers and directs activities to influence the external regulatory environment in accordance with GRA priorities. Responsible for oversight of regulatory review of advertising, promotion, medical, media relations and other internal and external communications related to company products and/or disease areas of interest. Mentors and develops direct reports for future leadership roles. Provides input into the global organization for promotional strategies, including launch strategies. Primary and senior-level therapeutic area liaison with FDA’s Office of Prescription Drug Promotion (OPDP) for drugs, Advertising & Promotional Labeling Branch (APLB) for biologics, and Division of Premarket and Labeling Compliance (DPLC) for medical devices, as applicable.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
In conjunction with the GRA’s US Head of Ad Promo, recommends and contributes to the development of strategic
objectives across assigned therapeutic areas
Fosters Sanofi’s Play to Win culture through an emphasis on identifying innovative approaches for achieving business
objectives while maintaining regulatory compliance in the interest of Sanofi and the patients we serve.
Contributes to the maintenance and enhancement of strategic relationships with internal and external stakeholders
Ensures that the regulatory environment is continually monitored for new regulations, guidance, and enforcement
priorities and trends
Provides development opportunities for direct reports contributing to GRA staff development and succession planning
Establishes and develops key internal relationships with R&D and Regulatory Product leads to foster open
communication and collaboration
Assures alignment and consistency in the US Ad Promo team’s application of company policies across therapeutic
areas and brands, taking into account the totality of product-related and company activities
Ensures therapeutic product relationships with FDA are established and maintained
Performs other duties as assigned
REQUIRED EDUCATIONAL BACKGROUND
Bachelor’s degree from an accredited four-year college or university (Area of specialization: Life Science)
REQUIRED JOB-RELATED EXPERIENCE
Experience within biopharmaceutical Regulatory Affairs advertising and promotion
Successful track record supporting pre-approval activities, product launches and promotion of established products
Effective collaboration with cross-functional teams, including Compliance, Legal, Marketing, Medical, and others.
Experience managing and developing direct reports.
KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE
Extensive knowledge and understanding of complex medical and scientific subject matter.
Possesses comprehensive breadth of technical knowledge in regulatory affairs and ensures dissemination of this knowledge to others throughout the organization.
Ability to work well within and lead cross-functional teams.
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 business 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-aventis values.
Capable of managing projects specific to the functional area and able to balance managing these projects with day-to-day duties, ensuring participation from other team members as needed.
Able to establish priorities and timelines to effectively self-manage workload.
Deals with people in an honest and forthright manner representing information and data accurately.
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.
Location: Cambridge, MA
Job date: Wed, 25 May 2022 22:01:11 GMT
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