.Are you a strategically focused Regulatory Affairs professional and would like to play an integral part in crafting drug development and gaining fast, efficient approvals?
If so, read on... At AstraZeneca, we have a team united by a shared passion to learn, grow and discover.
This role, as a Regulatory Affairs Director (RAD), provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned product(s).
The RAD applies knowledge of current local and global regulatory trends to identify future requirements and strategies and influences authorities through regular contacts to improve outcomes.
What you'll do Develop and implement the regional or global regulatory strategy to deliver rapid approval with competitive labelling that is identified by the business, markets and patients.
Lead the development of the global regulatory strategy document for assigned product(s) and the planning and construction of the global dossier and core prescribing information.
Lead cross functional teams in major regulatory submissions (BLA/MAA/IND/CTA), health authority interactions, label discussions, and securing approvals.
Deliver regulatory achievements for assigned project(s), including the assessment of risks and mitigations, emerging data and the probability of regulatory success.
Ensure effective collaboration across global, regional and local Regulatory Affairs, enabling rapid and effective submissions, approvals and other product maintenance activities.
Participate in skill-development, mentoring and performance feedback of other regulatory staff working on the product/project.
Your Education, Qualifications, Skills and Experience Essential Bachelor's Degree in a life science or related field.
Significant experience in early and late-stage regulatory drug development, manufacture, commercialization.
Knowledge of regulatory procedures and legislation for drug development, product registration, line extensions and license maintenance.
Proven successful leadership and project management experience.
Desirable Previous experience in vaccines or immune therapies is strongly preferred.
Advanced degree in science related field and/or other appropriate knowledge/experience.
Ability to work strategically within a business-critical and high-profile development program.
Critical thinking on current global regulatory science questions and a good understanding of the corresponding scientific and clinical components.
Locations UK: Cambridge; MacclesfieldSpain: BarcelonaSweden: Gothenburg; SödertäljeUSA: Gaithersburg, MD; Durham, NC; Waltham, MA; Wilmington, DECanada: Mississauga, ONT Rewards Competitive salary and excellent benefits, relocation support available.
Next Steps Why AstraZeneca?
Working here is about more than the science of saving lives.
It's about the people who work here.
Continuous learning is good for the individual and good for the business too