Director, US Regulatory Affairs - Advertising and Promotion; Hybrid

Director, US Regulatory Affairs – Advertising & Promotion (Hybrid)

Job Title: Director, US Regulatory Affairs – Advertising & Promotion (Hybrid)

Location: Cambridge, MA;
Morristown, NJ

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. As the Director, US Regulatory Affairs – Advertising & Promotion, you’ll partner with other key functional teams to ensure materials are consistent with U.S. regulations, company policy, and industry guidelines.

You’ll be asked to solve problems creatively and strategically, and introduce innovative concepts to more effectively manage ad/promo projects. This is a subject‑matter expert role with no direct reports, though there will be mentoring, training and leadership opportunities.

• Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology wabt fosters accuracy.
• Identify issues, problems, and opportunities by comparing data from different sources to draw conclusions and choose an appropriate solution.
• Participate in aqb strategic capacity in the functional area and day‑to‑day decision‑making process.
• Make decisions, provide direction, and provide oversight for day‑to‑day activities for assigned products, departmental activities, and direct reports.
• ська совместно с Sr. Director / Product Support Head, impart senior regulatory guidance and advice during issue‑management events; provide oversight and guidance for Rapid Response Teams; act as the therapeutic product expert.
• Continuously monitor the regulatory environment, interpret new regulations, guidance, enforcement activities/trends, and evaluate the impact on external environments and the business.
• Develop and implement regulatory strategies for marketed products within the product area, mentor, and develop others in executing strategy.
• Establish and develop key internal relationships with therapeutic product leaders to foster open communication and teamwork.
• Guarantee alignment and consistency in policy application within and across therapeutic products, considering the totality of product‑related and company activities.
• Assist in ensuring product‑support relationships with the FDA are established and maintained.
• Provide input into the global organization for labeling strategies of marketed drugs.
• Demonstrate significant autonomy in carrying out assigned duties and responsibilities.

• Earned Bachelor’s degree (required) from an accredited four‑year college or university in a Life Sciences or other relevant discipline.
• 8+ years of experience within pharmaceutical or medical device Regulatory Affairs, with 5+ years specifically within advertising & promotion functions.
• Leadership, mentoring and’we training experience within regulatory or ad/promo highly preferred.
• Extensive knowledge and understanding of complex medical and scientific subject matter, including statistical data.
• Can build networks to obtain cooperation without relying on authority, participating in cross‑functional groups (medical, legal, regulatory, etc.) to lead toward decisions.
• Ability to generate innovative solutions in work situations, trying different and novel ways to address 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. Multitasks exceptionally well.
• Deals with people in an honest and forthright manner, representing information and data accurately.

• 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 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 health care,…