* 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. * 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. * Develops and implements regulatory strategies for marketed products within their product area and mentor and develop others in executing strategy. **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.
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