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 more effectively manage ad/promo projects.
Participate in a more strategic capacity in the functional area and day-to-day decision-making process.
Provide direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports.
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 monitor the regulatory environment, interprets new regulations, guidance, 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.
Establish and develop key internal relationships with therapeutic product leaders to foster open communication and teamwork.

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/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.
Can build networks to obtain cooperation without relying on authority, including participating in cross-functional groups (medical, legal, regulatory, etc.) to lead toward decisions.
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