Senior Director, Promotional Regulatory Affairs, Delaware, OH
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Delaware, OH, USA
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Last edited: less than a week ago
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- Team Leadership and Development: Manage, develop and lead a team responsible for provision of strategic advice and review of promotional materials across a therapeutic area, ensuring staff development and adherence to established processes.
- Promotional Regulatory Strategy: Set promotional regulatory strategy and priority for the therapeutic area; advise senior leadership on the promotional regulatory impact of business strategy development; provide input to global teams on US promotional impact.
- Material Review Excellence: Oversee efficient regulatory review of promotional materials across all segments and media through the MLR process; liaise with Commercial Operations on MLR governance to drive consistency and speed.
- Senior Counsel and Influence: Advise senior leadership on complex promotional regulatory matters and exert substantial influence internally and externally to align on compliant, high-quality outcomes.
- Process and Guidance Improvement: Drive process improvement and development of PRA guidance and job aids; contribute to PRA initiatives and develop departmental guidance that enables faster, better decisions.
- External Representation: Represent AstraZeneca as a subject matter expert in interactions with regulatory authorities and relevant external forums, strengthening credibility and shaping standards.
- Requires a degree in pharmacy, pharmacology, science, or related field (or equivalent experience).
- Needs 7+ years in promotional regulatory affairs or FDA advertising/promotion review.
- Requires 10+ years in drug/biologic regulatory affairs or a related pharmaceutical/biotech field.
- Experience successfully leading teams, directly or indirectly, and influencing and mentoring others.
- Expert knowledge and application of FDA promotional regulations.
- Ability to successfully engage senior leaders/executive presence.
- Knowledge of drug development process and team collaboration.
- Strong communication, influencing, and analytic skills.
- High ethical standards and compliance.
- Ability to manage projects and workloads independently.
- Experience with VEEVA Promo Mats is preferred.
- Therapeutic area expertise relevant to AstraZeneca.
- Background in pharmaceutical promotional regulatory, compliance, or medical affairs.
Date Posted
26-May-2026Closing Date
01-Jun-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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Job positionSenior Director, Promotional Regulatory Affairs
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