Translational Regulatory Affairs Senior Director - Barcelona, España - AstraZeneca

AstraZeneca
AstraZeneca
Empresa verificada
Barcelona, España

hace 1 mes

Isabel García

Publicado por:

Isabel García

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Descripción
Are you a strategically focussed 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 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 (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.

Translational areas are development opportunities that take place in other functional teams than Regulatory Affairs and focus on biomarkers or approaches such as the development of ctDNA as a novel endpoint.

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 the early 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 use in oncology drug development.

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.


Typical Accountabilities, what you will be doing:

  • Own the relevant regulatory activities with a team of specialists and drive a global approach.
  • Develop regulatory plans to support biomarker strategies (e.g. ctDNA), assaydriven strategies, or novel approaches using digital for the entire Oncology Portfolio. Develop global regulatory strategies to support the development of biomarkers, companion diagnostics, digital health and other devices to enhance the value of oncology drug products.
  • Optimally communicate strategies with the involved functions in the TA organization.
  • Lead the objective assessment of emerging science, technology, and changes in the regulatory environment and advise senior management on project risks/mitigation activities accordingly.
  • As needed, develop and coordinate crossfunctional workshops focused on translational regulatory topics.
  • Drives external engagement opportunities, and contribute to relevant publications, external speaking events.
  • Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.
  • Ensure high quality collaboration with cross
- functional teams to facilitate biomarker-driven oncology drug development. Ensure global regulatory plans support translational and precision medicine approaches e.g. integrated drug/diagnostic regulatory and submission plans, including health authorities (HA) engagement plans and mitigation strategies.

  • Ensure high quality collaboration with global regulatory leads and provides guidance to the regional strategists and collaborates in strategic meetings with HA. May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic regulatory advice and be accountable for all regulatory activities.
  • Provides strategic input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, BLAs, CTAs, IDEs, and PMAs for drug and diagnostic products.

Education, Qualifications, Skills and Experience:


Essential:


  • An advanced degree in a science related field and/or other appropriate knowledge/experience.
  • Experience and understanding of drug development tools (e.g. biomarkers, ctDNA) are preferred. Understanding of scientific content and complexities of diagnostic development, including experience of IDE submissions and approvals.
  • Previous demonstrated experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labelling negotiations would be a plus.
  • A solid knowledge of regulatory affairs within at least one th
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