Partner with other key functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines.
Solve problems creatively and strategically, and introduce innovative concepts to manage ad/promo projects.
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.
Evaluates the impact on external environments and the business.
Develops and implements regulatory strategies for marketed products within the product area.
Mentor and develop others in executing strategy.
Establishes and develops key internal relationships with therapeutic product leaders to foster open communication and teamwork.

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.
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.

Director, US Regulatory Affairs – Advertising and Promotion

Key skills