Massachusetts Healthcare Jobs

Job title : Director, US Regulatory Affairs - Advertising and Promotion

Location: Cambridge, MA or Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

In at least one product area, you will be considered the resident expert in Global Regulatory Affairs Region NA, Advertising & Promotion (A&P) group on promotional, labeling, product defense, and development strategies. You will be responsible for decision-making, direction, and oversight of the day-to-day activities of assigned products, departmental activities, and direct reports in order to meet internal and external customer needs.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports.

• In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams; functions as the therapeutic product expert for Region NA, A&P.

• Continually monitors the regulatory environment, interprets new regulations, guidance’s, and enforcement activities/trends and evaluates the impact on external environments and the business.

• Develop and implement regulatory strategies for marketed products within their product area and mentor and develop others in executing strategy.

• Establishes and develops key internal relationships with therapeutic product leaders in R&D and Corporate to foster open communication and teamwork.

• Assures alignment and consistency in Region NA, A&P policy application within and across therapeutic products; takes into account the totality of product-related and company activities.

• Assists in ensuring product support relationships with FDA are established and maintained.

• Provides input into the global organization for labeling strategies of marketed drugs. Demonstrates significant autonomy in carrying out assigned duties and responsibilities.

About You

Experience

• 8+ years of experience within pharmaceutical or medical device Regulatory Affairs

• Successful track record of relevant advertising & promotion regulatory experience

• Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing, etc.

• Experience managing others is preferred

Education

• Minimally, posses a Bachelor’s degree from an accredited four-year college or university in a relevant Life Sciences discipline or specialization

Additional 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.

• 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.

• Can build networks to obtain cooperation without relying on authority. You will also have the ability to work well within cross-functional teams.

• 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.

• 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

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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.

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)