Associate Regulatory Affairs Director

Associate Regulatory Affairs Director

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

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
• 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

Preferred Qualifications

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