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

Sanofi•Cambridge, MA

6d•Hybrid

About The Position

This role partners with key functional teams to ensure advertising and promotion materials are consistent with US regulations, company policy, and industry guidelines. The position requires creative and strategic problem-solving and the introduction of innovative concepts for effective ad/promo project management. It is a subject matter expert role with no direct reports, but offers mentoring, training, and team leadership opportunities. The company is an innovative global healthcare company focused on accelerating scientific discovery to improve people's lives, offering opportunities for career growth and development.

Requirements

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
5+ years specifically within advertising & promotion functions
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.
Able to multitask exceptionally well.
Deals with people in an honest and forthright manner representing information and data accurately.

Nice To Haves

Leadership, mentoring and/or training experience within regulatory or ad/promo is highly preferred

Responsibilities

Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology.
Understand issues, problems, and opportunities by comparing data from different sources to draw conclusions and then choose a course of action or develop the appropriate solution.
Regularly demonstrate the ability to participate in a more strategic capacity in the functional area and day-to-day decision-making process.
Make decisions, provide 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, impart senior regulatory guidance and advice during issues management activities; provide oversight and guidance for Rapid Response Teams, and function as the therapeutic product expert.
Continually monitor the regulatory environment, interpret new regulations, guidance, and enforcement activities/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 and develop others in executing strategy.
Establish and develop key internal relationships with therapeutic product leaders to foster open communication and teamwork.
Assure alignment and consistency in policy application within and across therapeutic products; take into account the totality of product-related and company activities.
Assist in ensuring product support relationships with FDA are established and maintained.
Provide input into the global organization for labeling strategies of marketed drugs.
Demonstrate significant autonomy in carrying out assigned duties and responsibilities.