Job title: Director, US Regulatory Affairs - Advertising and Promotion
Location: Cambridge, MA or Morristown, NJ

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.

• 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.