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About the Role

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist 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, identifying submission risks and opportunities, and driving high-quality global regulatory authority engagements and submissions.

Responsibilities

Partner closely with members of the global regulatory team to define stage-appropriate regulatory strategy in alignment with global regulatory requirements and expectations.
Closely monitor evolving global and regional regulatory guidelines, policies, and procedures.
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.
Advise regulatory and cross-functional teams of opportunities to accelerate development by evaluating risks and identifying potential solutions.
Participate in meetings with Health Authorities to gain direct exposure to regulatory feedback.
Contribute to submission delivery strategies for all dossiers and application types that are responsive to health authority advice.
Analyze regulatory procedures and special designations used during development, authorizations and extension of the product.
Use and share best practices during interactions with health authorities and in day-to-day work.
Develop, execute and maintain submission delivery plans and submission content plans.
Proactively provide status updates to designated stakeholders.
Support operational and compliance activities for assigned projects.
May assume 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, 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
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

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
Continuous Improvement and knowledge sharing focused

Experience Level

5+ years of Regulatory experience
7+ years of Regulatory experience

Education Level

Bachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field
Master’s, PharmD, or PhD degree in Science, Regulatory Sciences, Pharmacy, or another related discipline

Salary/Compensations

$135,624.80 - $203,437.20 USD Annual

Benefits

Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage

About the Company

At AstraZeneca we’re dedicated to being a Great Place to Work.
Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.
There’s no better place to make a difference to medicine, patients and society.
An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development.
We’re on an exciting journey to pioneer the future of healthcare.

Equal Opportunity

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.
In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.
If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.