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Associate Director, Promotional Regulatory Affairs
Location:
Wilmington, DE
Description:
Join us at AstraZeneca, where we turn ideas into life-changing medicines. As an Associate Director in Promotional Regulatory Affairs, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. In conjunction with the TA Senior Director, Respiratory & Immunology Therapeutic Area, PRA, you will provide leadership and promotional regulatory expertise to ensure that our promotional practices are consistent with regulatory and legal guidelines.Accountabilities:As an Associate Director, you will be responsible for reviewing, evaluating, and approving promotional materials and commercial activities within established time frames. You will apply your regulatory and therapeutic area knowledge to meet marketing objectives while minimizing regulatory risk. You will provide regulatory expertise to promotional material review team meetings and business partnering on complex topics. You will also monitor the regulatory environment for your therapeutic area and actively participate in training initiatives of the Promotional Regulatory Affairs Skill Center.Essential Skills/Experience:Bachelor's degree in science2 years' experience in regulatory affairs, medical information, clinical development, clinical safety or pharmaceutical advertising agency; or, minimum of 1 year relevant industry experience (e.g., post-doctorate fellowships) plus PharmD/PhDKnowledge of FDA regulations and drug development processExperience in project management and working in a team-based environmentExcellent verbal and written communication skillsDemonstrated proficiency in the following competencies: exemplary compliance ethics, high concern for standards, significant attention to detail, strategic and analytic thinkingDesirable Skills/Experience:3+ years' experience in Promotional Regulatory AffairsAdvanced degree in pharmacy, pharmacology, or other life scienceDirect interaction with various levels of commercial management on issue resolutionExperience in Respiratory & Immunology therapeutic areaExperience interacting with OPDP, FDA reviewing divisions, or equivalentAt AstraZeneca, we're not just about treating diseases - we're about changing lives. We're a global biopharmaceutical company that believes in pushing the boundaries of science to deliver life-changing medicines. We're committed to the relentless pursuit of innovation. We believe in the power of what science can do. And we need your talent to help us achieve our mission.Are you ready to make a difference? Apply today and help us change the course of medicine! Date Posted 14-May-2024 Closing Date 30-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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More About this Listing: Associate Director, Promotional Regulatory Affairs
Associate Director, Promotional Regulatory Affairs is a Executive Associate Director Job at Astrazeneca located in Wilmington DE. Find other listings like Associate Director, Promotional Regulatory Affairs by searching Oodle for Executive Associate Director Jobs.
Associate Director, Promotional Regulatory Affairs is a Executive Associate Director Job at Astrazeneca located in Wilmington DE. Find other listings like Associate Director, Promotional Regulatory Affairs by searching Oodle for Executive Associate Director Jobs.