Senior Translational Regulatory Affairs Director

**This opportunity is available at our Gaithersburg, MD & Waltham, MA (USA), Mississauga (Canada), or 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)**, **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 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. Translational areas are development opportunities that take place in cross
- functional teams and focus on biomarkers or approaches such as the development of novel endpoints, biomarkers, assays or the introduction of digital therapeutics in the development programs. This requires to anticipate early the potential regulatory impact and to develop the capabilities to design regulatory strategies applicable to late development projects, which meet regulatory agencies requirements. The Translational RAD develops interfaces between the functional areas involved in these projects, participate in the projects as a project team member, and help identify all necessary regulatory aspects that may benefit from interactions with regulatory authorities in both early and late stage of development or through an on-going development program. The role plays a key role in working closely with the RADs assigned to development programs and contributes to the development organizing regulatory authorities interactions dedicated to focused topics to be an integral part of a development program, e.g, ctDNA, computational pathology, SaMDs, proteomics.

**Accountabilities will include**:

- Provide leadership for global regulatory strategy to support the development of in vitro diagnostic (IVD) projects and CDx products to project teams and other functions as needed. Ensures global regulatory plans support a precision medicine approach (e.g. integrated drug/diagnostic regulatory and submission plans)
- Develop and implement regulatory strategies to support the development of clinical biomarkers and assays
- Collaborate closely with cross-functional teams and actively involved in decision making on biomarker and IVD/CDx related drug development questions
- Represent Regulatory Affairs on assigned global IVD/CDx project teams
- Provide strategic input on key development and regulatory documents, guide the review process, ensure scientific consistency, compliance to regional and global IVD/CDx regulations
- Interact with major health authorities to ensure successful regulatory submissions
- Organize and drives preparations for meetings and teleconferences with local and global HA officials with IVD focus
- Represent the company in regulatory interactions with regulatory agencies
- Stay up-to-date with relevant regulatory guidelines and understand the corresponding clinical and scientific components
- Drive external engagement opportunities, and contribute to relevant publications and external speaking events

**Minimum Qualifications**:

- Advanced degree in life science or relevant field, e.g. Ph.D., Pharm.D., M.Sc.
- At least 5 years of regulatory affairs experience or related knowledge/experience;
- Expert knowledge of the regional biomarker, IVD/CDx regulations and advanced knowledge of global IVD/CDx regulations
- Previous demonstrated experience of regulatory co-development of CDx with therapeutic product and experience with major Health Authority interactions
- 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**:

- Technical experience in ctDNA, NGS, or computational pathology would be advantageous
- Prior experience with oncology regulatory affairs; Understand the strategic and tactical roles and deliverables of global regulatory strategy in drug development
- Demonstrates teamwork and leadership skills, effectively collaborate with inter