Translational Regulatory Affairs Director - Digital Health

This opportunity is available at our Gaithersburg, Maryland, Mississauga, Canada, and Barcelona, Spain locations.

Are you a strategically focused Regulatory professional and 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 and Strategy & Excellence (ORSSE) and Oncology Digital Health, we bring hope and solutions to patients with unmet needs 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 Translational Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of assigned product(s) with a specific focus on translational areas. The successful candidate will be responsible for developing and implementing regulatory strategies for digital health technologies and clinical outcome assessments (COAs) in oncology drug development. This will involve working closely with cross-functional teams to ensure that regulatory requirements are met throughout the drug development process. This role plays a key role in working closely between COA specialists, Digital Health specialists and Regulatory scientists assigned to development programs and leads regulatory authority interactions dedicated to focused topics  as an integral part of a development program.

The impact of this position is high with implication on regulatory decisions, timelines and advancement for the company in contributing to the ORSSE “Roadmap” implementation.

Major Duties and Qualifications:

• Develop and implement regulatory plans, strategies and approaches for integrating COAs and digital health technologies into oncology and hematology programs.

• Collaborate and communicate closely with cross-functional teams to facilitate COA development and ensure that regulatory requirements are met throughout the drug development process.

• Own the relevant regulatory activities and provide strategic input on key development and regulatory documents, clinical protocols, study reports, IBs, INDs, NDAs, MAAs, and BLAs. Ensure global regulatory plans supporting digital approaches, including regulatory submission plans, health authorities (HA) engagement plans and mitigation strategies.

• Stay up-to-date with relevant regulatory guidelines and developments in the field of digital health technologies and COAs in oncology and hematology drug development.

• Ensure high quality collaboration with global regulatory leads and provides guidance to the regional strategists in strategic meetings with health authorities.

• Represent the company in regulatory interactions with regulatory agencies.

• Lead the objective assessment of emerging digital technology, and changes in the regulatory environment and advise senior management on project risks and mitigation activities accordingly.

• Drive external engagement opportunities and contribute to relevant publications and external speaking events.

Minimum Qualifications:

• Bachelor’s degree in life science or related field

• At least 5 years of regulatory affairs experience or related knowledge/experience.

• Extensive knowledge of digital health technologies and COAs in oncology and hematology drug development.

• Previous demonstrated experience of regulatory drug development or equivalent, and experience with major Health Authority interactions (US or Ex-US)

• A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.

• Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.

• Strong communication, negotiation, and problem-solving skills.

• Ability to work effectively in cross-functional teams and manage multiple priorities.

• Excellent organizational and project management skills.

• Strong attention to detail and ability to work independently.

Desirable Qualifications:

• Advanced degree is preferred.

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

• A good 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 a complex, business critical and high-profile development program.

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

• Understanding of strategic and tactical roles and deliverables of Global Regulatory Strategy in the drug development.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/  

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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 authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.