Associate Regulatory Affairs Director

AstraZeneca • Gaithersburg, MD

16h

About The Position

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management experience and a track record of advancing innovative therapies through key clinical development milestones. As a key member of the global regulatory strategy team (GRST), you are responsible for partnering with senior regulatory experts to support the end-to-end regulatory strategy planning, coordination, and execution of assigned cell therapy projects. The ARAD is solutions-oriented and a key contributor to regulatory strategy development, the identification of submission risks and opportunities, and drives high quality global regulatory authority engagements and submissions. The ARAD provides regulatory expertise and guidance on the clinical development requirements, including procedural and documentation requirements to regulatory and cross-functional teams, working flexibly within and across regions to achieve business objectives.

Requirements

• Bachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field
• 5+ years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• Thorough Knowledge of drug development
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams
• Excellent written and verbal communication skills
• Cultural awareness
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Proficiency with common project management (e.g., MS Project) and document management tools
• Ability to work independently and as part of a team
• Influencing and stakeholder management skills
• Ability to analyze problems and recommend actions
• Continuous Improvement and knowledge sharing focused

Nice To Haves

• Master’s, PharmD, or PhD degree in Science, Regulatory Sciences, Pharmacy, or another related discipline
• 7+ years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• Managed complex regulatory deliverables and submissions across projects/products
• Managed CTA or first wave Marketing Applications and/or LCM submissions with application of IVDR/GMO
• Knowledge of AZ Business and processes
• Experience and expertise using Artificial intelligence tools

Responsibilities

• Partner closely with members of the global regulatory team, to define stage appropriate regulatory strategy in alignment with global regulatory requirements and expectations, to bring innovative cell-based gene therapies to patients.
• Closely monitor evolving global and regional regulatory guidelines, policies, and procedures to support efficient, scientifically rigorous, and patient-centric development plans.
• Lead and contribute to the planning, preparation, review, and submission of regulatory submissions (e.g., IND, CTA, GMO, BLA, IVDR) s for cell-based gene therapies across all regions, ensuring proper documentation and compliance with internal and external standards.
• Advise the regulatory and cross-functional teams of available opportunities to accelerate development by evaluating risks and identifying potential solutions to address regulatory hurdles.
• Participate in meetings with Health Authorities to gain direct exposure to regulatory feedback and enable: Contribution to submission delivery strategies for all dossiers and application types that are responsive to health authority advice Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Support some operational and compliance activities for assigned projects.
• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
• Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group.
• Contribute to governance meetings and process improvement.

Benefits

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

What This Job Offers

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