Director Of Regulatory Affairs

Principal Responsibilities:

• Identify applicable regulatory requirements for conducting clinical trials
• Serve as the regulatory representative and work collaboratively at project meetings with cross- functional teams to achieve common goals, products in early and mid-stage development
• Effectively communicate the regulatory strategy, risks mitigation, and overall plans to program teams and senior management
• Manage filings of necessary regulatory documents and manage lead meetings with regulatory agencies and other reviewing bodies
• Content writing, compilation, maintenance, and review of all sections of the regulatory dossier such as DMF, IND/CTA, briefing packages, and life-cycle management of technologically complex biological products (vaccines, immune therapies)
• Regulatory strategy in and outside of the US
• Some domestic and international travel may be required
• Manage regulatory timelines, identify, and address gaps in planning and resourcing
• Occasional coordination with international vendors and potential work outside of core working hours to support may be required
• Manage and help negotiate the regulatory activities of contract research organizations, consultants, and contractors in the preparation of regulatory submissions

Qualifications:

• Strong project management, organization, communication, and interpersonal skills to work effectively with study sponsors, investigators, and subject matter experts involved in R&D projects
• Knowledge of regulatory requirements across development stages
• Experience in regulatory liaison/strategy including a broad understanding of FDA and ICH regulations, processes, and issues in therapeutic/vaccine development
• Regulatory Affairs Certification (RAC) or other regulatory certification preferred
• Experience with documentation and lifecycle management within the biotechnology industry preferred

Education/Experience:

• A minimum of 6-8 years of relevant regulatory experience is required; preferably including vaccine development and/or cancer immunotherapy
• PhD (preferred) or other advanced degree (MS, MD or equivalent) in a relevant scientific field required