Director of Translational Regulatory Science at AstraZeneca in Gaithersburg, Maryland

Job Description:

Are you a strategically focused Regulatory professional who would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us! At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover. Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients.



Accountabilities:



In this role, you will be responsible for developing, aligning, and implementing regulatory strategies to ensure successful early and late Oncology development projects on a global scale. You will serve as the regulatory lead on early-stage projects or specific indications of larger programs. The successful candidate will work closely within cross-functional teams to ensure that regulatory requirements in Oncology clinical trials, including those for innovative biomarkers, technologies (e.g., ctDNA, computational pathology, AI/ML), and therapeutics are met throughout the drug development process.



Essential Skills/Experience:

• Ph.D., Pharm.D., or Masters of Science degree in life sciences or a related field.


• Minimum of 5 years of experience in regulatory affairs or a closely related field.


• Expertise in therapeutic product regulations, with a detailed understanding of global regulatory frameworks.


• Understanding of regulatory affairs in Oncology throughout both early- and late-stage development.


• Demonstrated proficiencies in strategic thinking, internal and external influencing, innovation, initiative, leadership, and exceptional oral and written communication skills.


• Strong abilities in communication, negotiation, and problem-solving.


• Proficiency in working within cross-functional teams and balancing multiple priorities.


• Excellent organizational and project management abilities, with keen attention to detail.


• Capacity to work autonomously while maintaining high-quality standards.

Desired Experience:

• Experience in Oncology (small molecules & biologics) is preferred.


• Prior experience with phase 3 design including end of phase 2 health authority interactions.


• Contribution to a regulatory approval including leading response team and labelling negotiation.


• Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.


• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.


• Ability to work strategically within innovative, business critical and high-profile development programs.


• Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.


• Technical experience and understanding of biomarker innovations such as use of AL/ML computational pathology, or digital health would be advantageous.

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.


The annual base pay (or hourly rate of compensation) for this position ranges from $154,403 to $239,105. 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're motivated by science, success and achieving our goals in a way that's novel and thoughtful. We see change as an opportunity, embracing the possibility to learn, grow and evolve. Supporting our peers is just as important to us, that's why we keep working together, sharing knowledge and setting each other up to succeed. As an industry-leading Oncology Regulatory function, we drive efficiency and innovation to bring medicines to patients as quickly as possible. We play a key role in making sure our transformative science born in labs will be transformed into real value for patients. We break down barriers between areas, working in partnerships internally and externally. We are striving for technology adoption and automation to drive efficiencies and new innovations. We believe that by asking questions and trying new things, we can drive innovation and develop modern approaches.


Are you ready to play your part in gaining approval for our novel work on unmet medical needs? Apply now to join our team at AstraZeneca!


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. Apply Now