Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
Work directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB submission.
Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials
Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines.
Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.
Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
Serve as FDA liaison for matters related to the advertising and promotion of assigned products.
Work with other RC team members to provide input into improvement of systems and/or processes.
Provide teams with insight into changes in the regulatory environment, including updates on FDA enforcement letters, meetings, guidance documents, and policies, etc.
Review current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed.

Earned Bachelor’s degree (required) from an accredited four-year college or university in a Life Sciences or other relevant discipline
5+ years of experience within pharmaceutical or medical device Regulatory Affairs, with 3+ years specifically within advertising & promotion functions
Leadership, mentoring and/or training experience within regulatory or ad/promo is 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.

Associate Director, Global Regulatory Affairs – Ad-Promo, Immuno-Oncology

Key skills