Partner with key functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines.
Solve problems creatively and strategically, introduce innovative concepts to effectively manage ad/promo projects.
Participate in strategic capacity in the functional area and day-to-day decision-making process.
Provide senior regulatory guidance and advice during issues management activities.
Continually monitor the regulatory environment, interpret new regulations, guidance, and enforcement trends and evaluate the impact on external environments and the business.
Develop and implement regulatory strategies for marketed products within their product area and mentor 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 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.

Director, US Regulatory Affairs – Advertising and Promotion

Key skills