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

About the role

The Director, US Regulatory Affairs - Advertising and Promotion will partner with other key functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines. They will solve problems creatively and strategically, and introduce innovative concepts to more effectively manage ad/promo projects.

Main Responsibilities

• Understand the U.S. pharmaceutical marketplace and medical terminology.
• Understand issues, problems, and opportunities by comparing data from different sources to draw conclusions and choose a course of action.
• Demonstrate ability to participate in a more strategic capacity in the functional area and day-to-day decision-making process.
• Makes decisions, provides 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 monitors the regulatory environment, interprets new regulations, guidance, and enforcement activities/trends and evaluates the impact on external environments and the business.
• Develops and implements 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 to foster open communication and teamwork.
• Affirms alignment and consistency in policy application within and across therapeutic products; takes into account the totality of product-related and company activities.
• Affirms ensures product support relationships with FDA are established and maintained.
• Provides input into the global organization for labeling strategies of marketed drugs.
• Shows significant autonomy in carrying out assigned duties and responsibilities.

About You

• 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
• 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 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
• Deals with people in an honest and forthright manner representing information and data accurately

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave