Sr. Manager​/Associate Director, Regulatory Affairs US Lead

Job Summary

Sr. Manager / Associate Director, Regulatory Affairs US Lead

Salary Range: $195,000 - $215,000 per year

We are seeking a dynamic and experienced Sr Manager / Associate Director of Regulatory Affairs. The role is responsible for ensuring the execution of the regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). Provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company's portfolio.

Leads and coordinates local project team members in developing a strategy for applicable documents/activities.

• Primarily functions as a US-Regulatory Leader and is responsible for ensuring the execution of the regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL).
• Provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company's portfolio.
• Depending on the candidate's skill set, may also be assigned as a Global Regulatory Leader (GRL) with full regulatory responsibility for one or more earlier stages.
• Leads and coordinates local project team members in developing a strategy for applicable documents/activities.
• Ensures the quality and content of submissions to Health Authorities.
• Depending on skill set and as deemed appropriate by the GRL, may lead regional Health Authority meetings and liaise with local Health Authority and company governance boards for assigned projects.
• Depending on the skill set and as deemed appropriate by the GRL, may be the document owner of briefing books to Health Authorities.
• Assist with the development of the global regulatory functional plan through the research, review, and interpretation of related product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling.
• Experience reviewing nonclinical, clinical, and CMC documentation (e.g., nonclinical study reports, clinical protocols/study reports, Investigator Brochures, CMC information/data) and contribute to content as needed.
• This position has a moderate-high level of autonomy with growth opportunities. Able to work in a Fast-paced environment, handling multiple demands is preferred.

• Advanced scientific degree (i.e., PhD, MD, Pharm
  
  D) or master's degree with at least 5 years of drug development experience. Experience in Oncology is a great plus.
• Global Experience is a plus.
• Knowledge of Global regulatory procedures and practices, and awareness of evolving regulatory reform initiatives, is desirable.
• Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies.
• Global Experience is a plus.
• Strong written, spoken, and presentation communication.
• Demonstrated attention to detail.
• Travel expected (10%).

Regulatory Affairs Leadership, US Regulatory Strategy, Global Regulatory Strategy Alignment, Global Regulatory Leader (GRL) Collaboration, Drug Development Lifecycle Support, Proof of Concept (PoC) to Post-Approval Support, IND/NDA/BLA Regulatory Strategy, Health Authority Submissions, FDA Regulatory Interactions, Health Authority Meeting Leadership, Briefing Book Development and Ownership, Regulatory Documentation Strategy, Global Registration Strategy Execution, Cross-Functional Team Leadership, Local and Global Project Team Coordination, Regulatory Governance Liaison, Regulatory Intelligence and Policy Interpretation, Target Product Labeling Strategy, Advisory Committee Analysis, Nonclinical Documentation Review, Clinical Documentation Review, CMC Documentation Review, Investigator Brochure Review, Clinical Protocol and Study Report Review, Quality and Compliance of Regulatory Submissions, Oncology Drug Development Experience, Global Regulatory Procedures and Practices, Regulatory Reform Awareness, Integrated Drug Development Knowledge, Regulatory and Business Strategy Integration, Scientific and Technical Writing, Executive-Level Communication and Presentations, Attention to Detail, Fast-Paced Environment Execution, Multi-Project Management, Autonomous Decision-Making, Pharmaceutical and Biotech Drug Development, Travel-Ready Regulatory Leadership

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