Director, US Regulatory Affairs - Advertising and Promotion; Hybrid

Role Summary

Director, US Regulatory Affairs - Advertising and Promotion oversees regulatory strategy for advertising and promotion in the US, partnering with cross-functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines. This is a subject matter expert role with no direct reports, though mentoring, training and team leadership opportunities exist.

Location:

Cambridge, MA;
Morristown, NJ.

• 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.
• 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, and functions as the therapeutic product expert.
• Continually monitors the regulatory environment, interprets new regulations, guidance, and enforcement activities/trends and evaluates the impact on external environments and the business.
• Develops and implements 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 to foster open communication and teamwork.
• Assures alignment and consistency in 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.

• Required:
  
  Earned Bachelor’s degree 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/or training experience within regulatory or ad/promo is 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, including 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 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 multitask exceptionally well.
• Deals with people in an honest and forthright manner representing information and data accurately.