AstraZeneca
Regulatory Affairs Director
$186K–$279K
US - Cambridge Kendall SQ - MA · Director · Full-time · Posted Oct 27, 2026
- Experience
- At least 3 years of regulatory strategy or related knowledge/experience; demonstrated regulatory drug development or equivalent experience.
- Education
- Bachelor's degree in a science related field; advanced degree preferred.
About the job
Provides global or regional regulatory leadership for oncology products across development, commercialization, and lifecycle management, guiding regulatory strategy, health authority interactions, and approvals.
What you'll do
- Lead regulatory submissions, health authority interactions, label discussions, and approval efforts.
- Develop and implement regulatory strategy, engagement plans, and global dossiers and product labeling.
- Lead and mentor cross-functional regulatory teams, managing milestones, risks, and key regulatory documents.
What they ask for
- Bachelor's degree in a science-related field.
- At least 3 years of regulatory strategy or related knowledge/experience.
- Knowledge of regulatory affairs in at least one therapeutic area across early and late development.
- Demonstrated drug-development or equivalent experience and experience with major health authority interactions.
Nice to have
- Advanced degree; experience with radio-conjugates.
- Oncology experience (small molecules and biologics); phase 3 design or end-of-phase-2 health authority interactions.
Pay
USD 186,232.80 - 279,349.20 (base salary)
Tools
NDA, BLA, IND, CTA
Model-written summary · the original posting is authoritative