Associate Regulatory Affairs Director

About the role

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 will partner 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, identifying submission risks and opportunities, and driving high-quality global regulatory authority engagements and submissions. The ARAD provides regulatory expertise and guidance on clinical development requirements, including procedural and documentation requirements, to regulatory and cross-functional teams, working flexibly within and across regions to achieve business objectives.

Responsibilities

• Partner closely with members of the global regulatory team to define stage-appropriate regulatory strategy in alignment with global regulatory requirements and expectations, bringing 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) for cell-based gene therapies across all regions, ensuring proper documentation and compliance with internal and external standards.
• Advise regulatory and cross-functional teams on 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 contribute to submission delivery strategies for all dossiers and application types responsive to health authority advice.
• Analyze regulatory procedures and special designations used during development, authorizations, and product extensions, sharing best practices for handling applications and procedures.
• Develop, execute, and maintain submission delivery plans and content plans, proactively providing status updates to designated stakeholders.
• Support operational and compliance activities for assigned projects.
• 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.

Requirements

• Bachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
• 5+ years of Regulatory experience within the biopharmaceutical industry, 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.

Preferred Qualifications

• Master’s, PharmD, or PhD degree in Science, Regulatory Sciences, Pharmacy, or another related discipline.
• 7+ years of Regulatory experience within the biopharmaceutical industry, 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 AstraZeneca business and processes.
• Experience and expertise using Artificial Intelligence tools.

Skills

• 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.
• Focus on continuous improvement and knowledge sharing.

Internal and External Contacts

• Global Regulatory Leads (GRLs).
• Regional Leads (e.g., US, EU, international RADs).
• Lead RPM.
• Regulatory skill group in CGT.
• Marketing Companies.
• Health Authorities.
• External Collaboration partners.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility to participate in equity-based long-term incentive program (salaried roles).
• Retirement contribution (hourly roles).
• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage.

Pay

The annual base pay for this position ranges from $135,624.80 - $203,437.20 USD. Base pay offered may vary depending on market location, job-related knowledge, skills, and experience. In addition, this position offers a short-term incentive bonus opportunity and eligibility to participate in an equity-based long-term incentive program (for salaried roles).