Job title: Director, US Advertising and Promotion, Global Regulatory Affairs
Location: Morristown, NJ / Cambridge, MA
About the job
As the Director, US Advertising and Promotion, Global Regulatory Affairs within our GRA Advertising and Promo Team, you will be responsible for decisions, providing strategic direction and oversight for the day-to-day activities for assigned products. Ready to get started?
Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.
Job Summary:
In this role, the candidate will serve as the resident expert in GRA US Advertising and Promotion (A&P) group on promotion, labeling, product defense, and development strategies for assigned product(s). The Director 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. Liaises with FDA regarding product promotion matters.
About Sanofi
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main 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
About You
Basic Qualifications:
Bachelor's degree from an accredited four-year college or university; Science focus preferred, but not required
Experience within pharmaceutical or medical device Regulatory Affairs
Successful track record with 8+ years relevant regulatory experience
Experience in Advertising and Promotion in Regulatory required
Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
Experience managing others preferred
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
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
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.
GD-SA??
LI-SA
LI-Onsite
vhd
Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
North America Applicants Only
The salary range for this position is:
$178,500.00 - $257,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
