AstraZeneca
Director of Translational Regulatory Science
AstraZeneca, Gaithersburg, Maryland, us, 20883
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 global regulatory lead (GRL) on early-stage projects or specific indications of larger programs and/or as the regional regulatory lead. 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.
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!
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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 global regulatory lead (GRL) on early-stage projects or specific indications of larger programs and/or as the regional regulatory lead. 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.
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!
#J-18808-Ljbffr