Introduction to Role:Are you ready to take on a role that requires knowledge of FDA promotional regulations to support assigned brand(s) and related business functions? As a PRA Director, you will independently work with a cross-functional review team, providing regulatory guidance and risk assessment. Your expertise will help our business teams develop and deliver initiatives that comply with applicable laws, rules, and regulations governing the advertising and promotion of pharmaceutical products in the US. You will represent AstraZeneca to regulatory authorities for assigned brand(s) and projects, providing promotional regulatory advice and support to cross-functional partners.Accountabilities:Your responsibilities will include efficient and effective regulatory review and risk assessment of promotional material for all segments and media. You will lead innovative regulatory strategy development and implementation, including risk identification and contingency planning. You will also provide guidance to business leadership with respect to the development of Brand(s) strategy. Additionally, you will monitor regulatory agency activities, new guidance documents, and emerging trends in the regulatory environment, sharing such information within PRA and the business.Essential Skills/Experience:- Bachelor’s degree in science or equivalent experience- 3+ years’ experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review- 5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience- Strong knowledge of FDA promotional regulations- Knowledge of the drug development and labeling processes- Experience working in a team-based environment- Confident in interactions with business leaders- Collaborative and solution-oriented mindset and approach- Strong verbal and written communication and influencing skills- Exemplary compliance ethics and high concern for standards- Strong strategic and analytic thinking and decision-making skills- Ability to manage a diverse workload and quickly adjust to changing business prioritiesDesirable Skills/Experience:- Advanced degree (PharmD, MS, PhD, JD)- 5+ years’ experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review- Experience influencing decision-making of others- Experience in managing, developing, and/or mentoring people- Experience interacting with OPDP or FDA Review division or equivalent experience.- Experience with [Oncology products], [Respiratory and/or Immunology Products], [Cardiovascular/Renal/Metabolic Products]- Experience with electronic review and approval programs (VEEVA PromoMats or other)When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Why AstraZeneca?AstraZeneca is a place where you can be at the forefront of medical innovation. We use our unique position as medical leaders across our enterprise and the healthcare ecosystem to shape the future of Healthcare. There's so much opportunity here as we continue to grow - no better place to improve patients' lives and develop with AstraZeneca. We believe in focusing on innovation that will make a real difference. Continuously evolving to be better, we utilize the latest science and technology to drive performance in an efficient way.Ready to join our thriving team? Apply now and make a meaningful impact - on patients' lives and your personal growth.Date Posted 21-Mar-2024Closing Date 04-Apr-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.
