Associate Regulatory Affairs Director

AstraZeneca • Gaithersburg, MD

2d

About The Position

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to all collaborators and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives globally. Accountabilities Lead and/or contribute to the planning, preparation, and delivery of both simple and complex submissions throughout the product’s life cycle. Drive and lead delivery-focused teams, e.g., GRET (Global Regulatory Execution Team) on a product level or RSDT (Regulatory Submission Delivery Team) for major submissions (MAA/NDA). Assume overall accountability for the planning, forecasting, and reporting, applying refined project and stakeholder management skills, ensuring optimized delivery of regulatory activities to time and quality. Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including: Submission delivery strategy of all dossiers and all application types per market and/or region. Review documents and provide regulatory input (e.g., response documents, high-level documents, study protocols, PSRs, etc.). Analysis of regulatory procedures and special designations used during development, authorizations, and extension of the product. Identify regulatory risks, opportunities, and proactively develop mitigation strategies for operational regulatory activities, e.g., planned submissions (with input from all team members). May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies. As a member of the Regulatory Affairs Manager community, the ARAD will be a recognized expert in the current regulatory environment. Understand the regulatory framework, including regional trends for various types of applications, procedures, and documents, in both small and large molecules with a particular focus on planning, delivery, and project management. Provide coaching, mentoring, and knowledge sharing within the RAM skill group. Contribute to process improvement.

Requirements

• Bachelor’s degree in science or a related field with 5+ years of regulatory experience within the biopharmaceutical industry or health authority
• 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
• 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

• Proficiency with common project management (e.g., MS Project) document management tools and Veeva Vault/ERV
• Managed complex regulatory deliverables across projects/products

Responsibilities

• Lead and/or contribute to the planning, preparation, and delivery of both simple and complex submissions throughout the product’s life cycle.
• Drive and lead delivery-focused teams, e.g., GRET (Global Regulatory Execution Team) on a product level or RSDT (Regulatory Submission Delivery Team) for major submissions (MAA/NDA).
• Assume overall accountability for the planning, forecasting, and reporting, applying refined project and stakeholder management skills, ensuring optimized delivery of regulatory activities to time and quality.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including: Submission delivery strategy of all dossiers and all application types per market and/or region.
• Review documents and provide regulatory input (e.g., response documents, high-level documents, study protocols, PSRs, etc.).
• Analysis of regulatory procedures and special designations used during development, authorizations, and extension of the product.
• Identify regulatory risks, opportunities, and proactively develop mitigation strategies for operational regulatory activities, e.g., planned submissions (with input from all team members).
• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
• Provide coaching, mentoring, and knowledge sharing within the RAM skill group.
• Contribute to 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

What This Job Offers

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