Director, US Regulatory Affairs - Advertising and Promotion (Hybrid)
- Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology.
- Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
- Regularly demonstrates the 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.
- In conjunction with the Sr. Director/Product Support Head, 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.
- Assures alignment and consistency in policy application within and across therapeutic products; takes into account the totality of product-related and company activities.
- Assists in ensuring product support relationships with FDA are established and maintained.
- Provides input into the global organization for labeling strategies of marketed drugs.
- Demonstrates significant autonomy in carrying out assigned duties and responsibilities.
- 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.
- 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.
- Deals with people in an honest and forthright manner representing information and data accurately.
- 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.
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#LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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