Director, US Regulatory Affairs - Advertising and Promotion (Hybrid)

Main Responsibilities:
- Understand the U.S. pharmaceutical marketplace and medical terminology.
- Identify issues/opportunities by comparing data sources, then select an approach or develop solutions.
- Participate strategically in the functional area and day-to-day decision-making.
- Provide direction and oversight for day-to-day activities for assigned products and departmental/direct-report activities.
- Provide senior regulatory guidance during issues management; oversee Rapid Response Teams; serve as therapeutic product expert.
- Monitor the regulatory environment, interpret new regulations/guidance/enforcement trends, and assess business impact.
- Develop and implement regulatory strategies for marketed products; mentor and develop others.
- Build internal relationships with therapeutic product leaders to enable communication and teamwork.
- Ensure alignment/consistency in policy application across therapeutic products.
- Support establishment/maintenance of FDA product support relationships.
- Provide input to global labeling strategy for marketed drugs.
- Demonstrate significant autonomy.

Qualifications & Skills:
- Bachelor’s degree (required) in Life Sciences or relevant discipline.
- 8+ years pharmaceutical/medical device Regulatory Affairs; 5+ years in advertising & promotion.
- Leadership, mentoring, and/or training experience (highly preferred).
- Strong knowledge of medical/scientific subject matter (including statistical data).
- Ability to build networks for cooperation via cross-functional groups.
- Creative problem-solving; appropriate interpersonal skills; can modify behavior for acceptance.
- Strong prioritization, timeline management, self-management, and multitasking.
- Honest, accurate representation of information/data.

Benefits (explicitly stated):
- Health and wellbeing benefits, including at least 14 weeks’ gender-neutral parental leave.