Regulatory Affairs Director (EU Lead)

ASTRAZENECA UK LIMITED; Cambridge; Sur place; GBP 120 000 - 170 000; Plein temps

Résumé du poste

AstraZeneca UK Limited is seeking a Regulatory Affairs Director to lead EU regulatory strategies for oncology, coordinating major submissions and health authority interactions across global regions. This role emphasizes strategic leadership, cross-functional collaboration, and ensuring timely approvals for innovative medicines.

You will partner with science, medical, and commercial teams in a global matrix, guiding labeling discussions and lifecycle management while delivering regulatory

Qualifications

• 5+ years' experience in regulatory affairs, regulatory strategy, or drug development.
• Experience preparing for major health authority interactions and developing briefing documents.
• Contribution to labeling strategy and regulatory submission planning/execution.
• Experience with IVDR, CTR, CTAs, MAAs; oncology experience preferred.
• Strong communication, strategic thinking and problem-solving skills.
• Experience in a global matrix environment with cross-functional alignment.

Responsabilités

• Lead regulatory submissions and health authority interactions (EMA and national bodies).
• Develop and implement regional/global regulatory strategy to enable rapid approvals.
• Guide briefing documents and lead meetings/rehearsals for health authorities.
• Mentor GRST members and drive regulatory milestones for oncology programs.
• Own negotiations with health authorities and deliver core regulatory documents.

Connaissances

Regulatory strategy

Drug development

Global regulatory affairs

Leadership

Stakeholder management

Formation

Bachelor's degree Life Sciences/Pharmacy/Biomedical Sciences

Description du poste

• Lead cross functional teams in major regulatory submissions (MAA/CTR/IVDR/CTA), health authority interactions with EMA or national European health authorities, label discussions, and securing approvals.
• Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets and patients.
• Craft the EU health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
• Key contribuiting members to the Global Regulatory Strategy Team (GRST) that includes regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST.
• Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling in collaboration with the GRL.
• Own the negotiations with health authorities and initiate and deliver key regulatory documents.
• Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.
• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance., Deliver critical regulatory milestones for Oncology that support programme progression and approvals.
• Build productive relationships with health authorities and key internal stakeholders.
• Provide strategic leadership across complex, high-profile development programmes.
• Influence decisions that drive patient access to innovative medicines in the EU market.

  Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or a related scientific discipline with a

• + 5 years' experience in regulatory affairs, regulatory strategy, or drug development within the pharmaceutical or biotechnology industry; including preparation for major health authority interactions, development of briefing documents, contribution to labeling strategy, and support for regulatory submission planning and execution. Experience with filing of IVDR, CTR, CTAs, MAAs, lifecycle management activities, and regulatory pathways (relevant to oncology products is preferred)
• Strong knowledge of global regulatory affairs across both early and late-stage development, with experience supporting or shaping regulatory strategies for major submissions and health authority, primarily In Europe.
• Outstanding communication, strategic thinking and problem-solving skills.
• Experience operating effectively in a global matrix environment, lead through complexity, and drive alignment across multiple functions is essential.

Preferred Qualifications:

• Advanced degree preferred.
• Experience in Oncology is preferred.
• Prior experience with phase 3 design including end of phase 2 health authority interactions.
• Contribution to a regulatory approval including leading response team and labeling negotiations.
• Knowledge and 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 business critical and high-profile development program.
• Critical thinking on current global and regional regulatory science questions and good understanding of the corresponding scientific and clinical component.

  Do you want to shape the future of oncology medicines and influence regulatory decisions that impact patients globally?

At AstraZeneca, we are driven by our commitment to advancing science and delivering life-changing medicines.

As a Regulatory Affairs Director, you will play a pivotal role in defining and executing EU regulatory strategies that accelerate innovation and bring transformative oncology therapies to patients worldwide.

This is an opportunity to lead complex regulatory initiatives across development, submission, approval and lifecycle management activities while partnering with leading scientists, clinicians and commercial teams across a global matrix environment.

Why AstraZeneca?

At AstraZeneca, we follow the science and put patients first. You will join a culture that values curiosity, courage and collaboration, where talented individuals are empowered to challenge convention and shape the future of healthcare. We invest in our people through meaningful career development, global mobility opportunities, leadership programmes and cutting-edge scientific innovation. Our Oncology business continues to redefine what is possible in cancer treatment, creating opportunities for regulatory leaders to influence some of the most exciting programmes in the industry.

Join AstraZeneca and help deliver the next generation of medicines that transform the lives of patients around the world.