Global Oncology Regulatory Director

AstraZeneca plc; Cambourne; Presencial; GBP 130.000 - 170.000; Jornada completa

Descripción de la vacante

AstraZeneca plc in Cambridge, UK is seeking a Regulatory Affairs Director to shape EU regulatory strategies for oncology programmes. You will lead cross-functional teams through major submissions, health authority discussions, labeling strategy and lifecycle management in a global matrix environment.

You will drive strategic engagement with EMA and national authorities, mentor GRST members, and deliver regulatory milestones while partnering with scientists, clinicians and commercial teams to

Formación

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or related field.
• Strong experience in regulatory affairs and strategy with major health authority interactions.
• Experience with IVDR, CTR, CTAs, MAAs and lifecycle management.
• Experience in Europe regulatory strategies for oncology products.
• Excellent communication and cross-functional collaboration skills.

Responsabilidades

• Lead cross functional teams in major regulatory submissions (MAA/CTR/IVDR/CTA).
• Develop and implement the program's regional/global strategy for rapid approvals.
• Craft EU authority engagement strategy and coordinate briefing documents.
• Contribute to Global Regulatory Strategy Team and mentor GRST members.
• Deliver regulatory milestones and manage risks for GRL collaboration.
• Negotiate with health authorities and prepare regulatory documents.
• Plan global dossier and core prescribing information, including maintenance.
• Partner with marketing and regional staff to influence guidance.

Conocimientos

Regulatory strategy

Health authority interactions

EU regulatory submissions

Lifecycle management

Educación

Bachelor's degree in Life Sciences

Descripción del empleo

AstraZeneca plc in Cambridge, UK is seeking a Regulatory Affairs Director to shape EU regulatory strategies for oncology programmes. You will lead cross-functional teams through major submissions, health authority discussions, labeling strategy and lifecycle management in a global matrix environment.

You will drive strategic engagement with EMA and national authorities, mentor GRST members, and deliver regulatory milestones while partnering with scientists, clinicians and commercial teams to