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Regional Liaison Director CVRM South
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Associate Director, Promotional Regulatory Affairs
4 months ago
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
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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