Associate Director of Translational Regulatory Science
hace 7 días
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. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
The Associate Director of Translational Regulatory Science provides strategic and regulatory leadership to the development, commercialization, and life cycle management of assigned product(s) with a specific focus on translational areas. Translational areas are development opportunities that take place in cross-functional teams and focus on biomarkers or approaches such as the development of novel therapeutics, endpoints, in vitro diagnostics (IVDs), regulatory innovations, or the introduction of digital therapeutics in development programs. This requires early anticipation of the potential regulatory impact and developing capabilities to design regulatory strategies applicable to early and late development projects, which meet regulatory agencies’ requirements. The Associate Director of Translational Regulatory Science interfaces between the functional areas involved in these projects, participates in the projects as a team member, and helps identify all necessary regulatory aspects that may benefit from interactions with regulatory authorities in both early and late stages of development or through an ongoing development program. The Associate Director of Translational Regulatory Science plays a key role in working closely with the Regulatory Affairs Directors (RADs) assigned to development programs and contributes to product development by organizing regulatory authority interactions dedicated to focused topics to be an integral part of a development program.
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. 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. The impact and visibility of this position are high, with implications for regulatory decisions, timelines, and advancement for the company in contributing to the ORSSE "Roadmap" implementation.
If you are a Regulatory professional with a passion for Oncology and want to make a difference in the lives of cancer patients, please apply to join our team at AstraZeneca.
Typical Accountabilities
- Guide the development of global regulatory strategies to facilitate the advancement of early and late Oncology programs, including those that involve innovative biomarkers, technologies, and therapeutics. Collaborate with project teams and other functions as necessary to ensure seamless integration of these elements into regulatory risk assessment and mitigation strategies, e.g. IVDR.
- Develop and implement regulatory strategies to support the clinical development of Oncology therapeutic products, ensuring alignment with organizational objectives.
- Work closely within cross-functional teams, actively participating in decision-making processes related to drug development queries.
- Serve as a Regulatory Affairs representative on designated global project teams, offering strategic insights and guidance on key development and regulatory documents. Oversee the review process, ensuring scientific coherence and compliance with regional and global regulations.
- Engage with major health authorities to optimize regulatory strategies and maintain productive relationships.
- Organize preparations for meetings and teleconferences with local and global health authority officials, focusing on biomarker and innovation-related topics.
- Keep abreast of relevant regulatory policies and guidelines, understanding their implications for clinical and scientific practices.
- Drive opportunities for external engagement, contributing to relevant publications and participating in external speaking events to enhance the company's visibility and influence in the regulatory landscape.
Education, Qualifications, Skills, and Experience:
- Advanced degree in life sciences or a related field, such as Ph.D., Pharm.D., or M.Sc.
- Minimum of 2 years of experience in regulatory affairs or a closely related field.
- Expertise in therapeutic product regulations, with a thorough understanding of global regulatory frameworks.
- Understanding of regulatory affairs in Oncology throughout both early and late-stage development.
- Demonstrated competencies 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 effectively within cross-functional teams and managing multiple priorities.
- Excellent organizational and project management abilities, with keen attention to detail.
- Capacity to work autonomously while maintaining high-quality standards.
- Prior experience with Oncology regulatory affairs; understand the strategic and tactical roles and deliverables of global regulatory strategy in Oncology drug development.
- Knowledgeable about regulatory co-development of IVDs/CDx with therapeutic products, with experience in engaging with major health authorities.
- Technical experience and understanding of biomarker innovations such as use of AL/ML computational pathology, or digital health would be advantageous.
Date Posted : 01-oct-2024
Location : Barcelona (on-site)
Closing Date : 15-nov-2024
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.
#J-18808-Ljbffr-
Barcelona, España Astrazeneca A tiempo completo.Associate Director of Translational Regulatory Science 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....
-
Barcelona, España Astrazeneca A tiempo completo.Location: Barcelona (on-site)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. We work across our pipeline...
-
Barcelona, España Astrazeneca A tiempo completoAssociate Director of Translational Regulatory ScienceWithin 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. We...
-
Barcelona, España Astrazeneca A tiempo completoAssociate Director of Translational Regulatory Science 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. We...
-
Barcelona, España Astrazeneca A tiempo completoAssociate Director of Translational Regulatory ScienceWithin 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. We...
-
Barcelona, España Astrazeneca A tiempo completoLocation: Barcelona (on-site)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. We work across our pipeline...
-
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona (on-site)** 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. We work across our...
-
Associate Director, Translational Data Science
hace 7 meses
Barcelona, España AstraZeneca A tiempo completo**Associate Director, Translational Data Science, Oncology Data Science, Oncology R&D, AstraZeneca** **Location**:Barcelona, Spain**: **Salary**:Competitive with excellent benefits The Computational Biology group is growing in Barcelona, and we are looking for new team members to join us at different roles (Sr Scientist/ Associate Director). AstraZeneca...
-
Translational Regulatory Affairs Director
hace 3 días
Barcelona, España Astrazeneca A tiempo completoLocation: Barcelona (on-site)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 &...
-
Translational Regulatory Affairs Director
hace 5 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona (on-site)** 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,...
-
Associate Director, Translational Medicine Lead
hace 5 meses
Barcelona, España AstraZeneca A tiempo completoDo you feel passionate about the possibilities of great science changing lives of cancer patients? Do you have a background within oncology and/or translational research and have interest in working with antibody drug conjugates (ADCs) and an exciting portfolio? If so, this may be the role for you. We currently have an exciting opportunity for a highly...
-
Regulatory Affairs Associate Director
hace 3 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring the company's compliance with global regulatory standards. Your key responsibilities will include:Leading a team of regulatory associates to drive high-quality documentation and...
-
Director, Translational Medicine Lead
hace 5 meses
Barcelona, España AstraZeneca A tiempo completoDo you feel passionate about the possibilities of great science changing lives of cancer patients? Do you have a background within oncology and/or translational research and have interest in working with antibody-drug and radio conjugates (ADCs and RC’s)? If so, this may be the role for you. We currently have an exciting opportunity for a highly motivated...
-
Regulatory Affairs Associate Director
hace 3 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob DescriptionAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring the company's products comply with global regulatory standards. Your key responsibilities will include:Leading and mentoring a team of regulatory associates to drive high-quality documentation and...
-
Regulatory Affairs Associate Director
hace 3 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAs a key member of our Regulatory Affairs team, you will play a critical role in driving and delivering high-quality documentation to support successful submissions, while ensuring compliance with current global regulatory standards.Key Responsibilities:Lead and mentor associates to ensure maximum regulatory...
-
Regulatory Affairs Associate Director
hace 3 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Summary:As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API (RAPI) department, responsible for driving and delivering high-quality documentation to support successful submissions. Your key responsibilities will include:Leading, coaching, and mentoring associates to ensure they have the...
-
Cmc Regulatory Affairs Associate Director
hace 2 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home** Our **Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs** function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of...
-
Associate Regulatory Affairs Director I
hace 4 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completoJob Title: Associate Regulatory Affairs Director ICareer Level - EIntroduction to Role:Join our Oncology R&D team as an Associate Regulatory Affairs Director I. This role is perfect for an experienced regulatory specialist with strong project management capabilities. You will be responsible for leading the end-to-end planning, coordination, and execution of...
-
Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, España Sandoz A tiempo completo.As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation...
-
Director, Translational Medicine, Oncology
hace 5 meses
Barcelona, España AstraZeneca A tiempo completo**Position**: Director/Associate Director, Translational Medicine, Oncology - DNA damage response** **Location**: Barcelona (primary) with alternative locations as Cambridge UK and Boston US** At **AstraZeneca**, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most...
