Associate Director, Promotional Regulatory Affairs at AstraZeneca

Posted in Other 6 days ago.

Location: Wilmington, Delaware





Job 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 science


  • 2 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/PhD


  • Knowledge of FDA regulations and drug development process


  • Experience in project management and working in a team-based environment


  • Excellent verbal and written communication skills


  • Demonstrated proficiency in the following competencies: exemplary compliance ethics, high concern for standards, significant attention to detail, strategic and analytic thinking




Desirable Skills/Experience:


  • 3+ years' experience in Promotional Regulatory Affairs


  • Advanced degree in pharmacy, pharmacology, or other life science


  • Direct interaction with various levels of commercial management on issue resolution


  • Experience in Respiratory & Immunology therapeutic area


  • Experience interacting with OPDP, FDA reviewing divisions, or equivalent




At 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!


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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