Regulatory Affairs Director

AstraZeneca • Gaithersburg, MD

22h • Hybrid

About The Position

The Infectious Disease Unit at AstraZeneca is constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We are utilizing our expertise in virology, microbiology and vaccines to enable novel approaches to prevent and treat infectious diseases. Within ID Regulatory Affairs, we take innovative regulatory approaches and work across our pipeline and the business to deliver medicines to patients as efficiently and effectively as possible. The Regulatory Affairs Director (RAD) is responsible for providing strategic 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 regulatory requirements and strategies and influences regulatory authorities through regular contacts to improve regulatory outcomes.

Requirements

• Bachelor’s Degree in a life science or related field.
• 7+ years of experience in regulatory drug development, manufacture, commercialization or equivalent
• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority
• Knowledge of regulatory procedures and legislation for drug development, marketing approvals, line extensions and license maintenance
• Proven successful leadership and project management experience
• Excellent oral, written, and presentation skills
• Ability to work in a fast-paced environment in a hands-on fashion

Nice To Haves

• Advanced degree in science related field and/or other appropriate knowledge/experience
• Previous experience in vaccines or anti-infective therapies
• Ability to work strategically in a global regulatory lead role on business-critical and high-profile development programs
• Experience supporting a global regulatory approval or major submission activity
• Experience with FDA advisory committee or EMA oral explanation preparation
• Experience working on due diligence activities or in a business alliance environment

Responsibilities

• Develop and implement the regional or global regulatory strategy, ensuring it is crafted 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 milestones 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, coaching and performance feedback of other regulatory staff working on the product/project

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program
• retirement contribution
• commission payment eligibility
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director