Join to apply for the Regulatory Affairs Director role at AstraZeneca.
Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life‑changing medicines?
At AstraZeneca, we do this with the utmost integrity, forging partnerships that help bring world‑class treatments to patients in new ways and combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs, working across our pipeline and the business to get medicines to patients as efficiently and optimally as possible.
What You’ll Do
* Lead cross‑functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health‑authority interactions, label discussions and securing approvals.
* Develop and implement the program’s regional or global strategy, ensuring it delivers rapid approval with competitive labeling identified by the business, markets and patients.
* Craft the health‑authority engagement strategy and interaction plan, drive the briefing document focused on strategy and scientific content, and lead the team through meeting rehearsals and moderate the meeting itself.
* Lead a Global Regulatory Strategy Team (GRST) of key contributors from regions, emerging markets, RA CMC, labeling and members of the submission and execution team, mentoring and providing performance feedback.
* Deliver regulatory milestones on your team, including risk assessment and mitigations, emerging data and probability of success. Lead preparation of the regulatory strategy document and target product labeling.
* Own 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 and guidance.
Minimum Qualifications
* Bachelor’s degree in a science‑related field with at least 3 years of regulatory strategy or related knowledge/experience.
* Strong knowledge of regulatory affairs within at least one therapeutic area in both early and late development.
* Previous demonstrated experience of regulatory drug development or equivalent, and experience with major health‑authority interactions.
* Demonstrated competencies in strategic thinking, influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.
Preferred Qualifications
* Advanced degree preferred.
* Experience in oncology (small molecules & biologics) 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 of guiding principles in drug development such as benefit‑risk profile, dose selection or statistical design.
* Broad background in pharmaceutical business and prior experience within regulatory affairs.
* Ability to work strategically within a business‑critical and high‑profile development program.
* Critical thinking on current global regulatory science questions and solid understanding of the scientific and clinical components.
Competitive Salary and Benefits Package On Offer
Details available on request.
Next Steps – Apply Today!
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 the work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non‑discrimination in employment and work authorization and employment eligibility verification requirements.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
Date Posted: 17‑Oct‑2025
Closing Date: 29‑Nov‑2025
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