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Director Regulatory Affairs

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. 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.​.

KBSkills

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Job Title: Director, US Regulatory Affairs - Advertising and PromotionLocation: Cambridge, MA or Morristown, NJAbout the jobAre 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.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:<ul><li>Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports.</li><li>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.</li><li>Continually monitors the regulatory environment, interprets new regulations, guidance’s, and enforcement activities/trends and evaluates the impact on external environments and the business.</li><li>Develops and implements regulatory strategies for marketed products within their product area and mentor and develop others in executing strategy.</li><li>Establishes and develops key internal relationships with therapeutic product leaders in R&D and Corporate to foster open communication and teamwork.</li><li>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.</li><li>Assists in ensuring product support relationships with FDA are established and maintained.</li><li>Provides input into the global organization for labeling strategies of marketed drugs. Demonstrates significant autonomy in carrying out assigned duties and responsibilities.</li></ul>About YouExperience:<ul><li>8+ years of experience within pharmaceutical or medical device Regulatory Affairs</li><li>Successful track record of relevant advertising & promotion regulatory experience</li><li>Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing, etc.</li><li>Experience managing others is preferred</li></ul>Education:<ul><li>Minimally, possess a Bachelor’s degree from an accredited four-year college or university in a relevant Life Sciences discipline or specialization</li></ul>Additional Skills:<ul><li>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.</li><li>Regularly demonstrates the ability to participate in a more strategic capacity in the functional area and day-to-day decision-making process.</li><li>Extensive knowledge and understanding of complex medical and scientific subject matter.</li><li>Can build networks to obtain cooperation without relying on authority. You will also have the ability to work well within cross-functional teams.</li><li>Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.</li><li>Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans.</li><li>Able to establish priorities and timelines to effectively self-manage workload. Is able to multi-task exceptionally well.</li><li>Deals with people in an honest and forthright manner representing information and data accurately. </li></ul>Why Choose Us?<div><ul><li>Bring the miracles of science to life alongside a supportive, future-focused team.​​</li><li>Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.​​</li><li>Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.​​​</li><li>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.​</li></ul>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</div>All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can <a href="https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi" rel="nofollow">be found here.</a>

Sanofi EU

Director, US Regulatory Affairs - Advertising and Promotion

Advertising

Biology

Biotech and Pharmaceutical

Capacity Strategy

Communication Skills

Compensation Management

Compensation and Benefits

Cross-Functional

Drug Development

Drug Discovery

Employee Benefits

Environmental Impact

Environmental Monitoring

Establish Priorities

FDA (Food and Drug Administration)

Healthcare

Healthcare Quality

International Health

Interpersonal Skills

Interpret Regulations

Legal

Marketing

Marketing Strategy

Medical Equipment

Medical Terminology

Medicine

Mentoring

Monitor Regulations

Multitasking

Policy Implementation

Power Amplifier

Product Marketing

Product Support

Regulations

Research & Development (R&D)

Team Player

Trend Analysis

TMP PX

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