Senior Manager, Regulatory Affairs

Salary Range

$170,000 - $190,000 per year

We are seeking a dynamic and experienced Sr. Manager 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 contributing 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%).

US Regulatory Affairs Leadership, Global Regulatory Strategy Execution, Drug Development Lifecycle Support (PoC to Post-Approval), Regulatory Submissions to Health Authorities, FDA and Global Health Authority Interactions, Global Regulatory Leader (GRL) Experience, Regional and Global Registration Strategy, Regulatory Strategy Development, Cross-Functional Team Leadership, Regulatory Document Strategy and Planning, Briefing Book Authorship and Ownership, Health Authority Meeting Leadership, Regulatory Governance and Agency Liaison, Regulatory Intelligence and Guidance Interpretation, Product Labeling Strategy, Nonclinical Documentation Review, Clinical Documentation Review, CMC Documentation Review, IND/NDA/BLA Support, Integrated Drug Development Knowledge, Oncology Drug Development Experience, Global Regulatory Procedures and Practices, Regulatory Compliance and Quality Oversight, Advisory Committee Research and Analysis, Strong Scientific and Technical Writing, Executive and Regulatory Presentations, Stakeholder Communication, Attention to Detail, Project Autonomy, Fast-Paced Multitasking Environment

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