Associate Director, Promotional Regulatory Affairs
The annual base pay for this position ranges from 134,054.00 - 201,081.00 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors
At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We are focused on the potential of science to address the unmet needs of patients around the world. In the Associate Director Promotional Regulatory Affairs role, you will play a pivotal role in helping patients access our life changing medicines.
In conjunction with the TA Senior Director, Promotional Regulatory Affairs, the Associate Director is responsible for providing leadership and promotional regulatory expertise in the review, approval, and submission of advertising and promotional materials to ensure that promotional practices are consistent with regulatory and legal guidelines.
What You'll Do:
- Reviews, evaluates, and approves promotional materials and commercial activities within established time frames to ensure compliance with regulatory and legal guidelines.
- Applies regulatory and therapeutic area knowledge with a solution-oriented approach to meet marketing objectives while minimizing regulatory risk.
- Provides regulatory expertise to promotional material review team meetings to ensure that AstraZeneca promotional materials comply with OPDP regulations
- Business partnering on complex and nuanced topics, including early phase brand planning, labeling discussions and commercial strategies and advice on FDA regulations and Guidance Documents
- Provides promotional regulatory advice and support from study design to labeling through successful launch, including new products, data, indications, and ISI updates
- Provides promotional regulatory advice pertaining to proactive use of HEOR and clinical trial proposals
- Monitors regulatory environment for therapeutic area and maintains awareness of competitor promotional activities
- Actively participates in training and other initiatives of the Promotional Regulatory Affairs Skill Center to help ensure continuous improvement in processes
- Adheres to corporate policies and conducts business in a professional and compliant manner
Essential for the role
- 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
Desired for the role
- 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 therapeutic areas of AZ focus
- Experience interacting with OPDP, FDA reviewing divisions, or equivalent
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There is no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We are on an exciting journey to pioneer the future of healthcare.
Are you already imagining yourself joining our team? Good, because we cannot wait to hear from you!
Where can I find out more?
Our social media, Follow AstraZeneca on LinkedIn
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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 authorisation and employment eligibility verification requirements.
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