Remote Position

Associate Director, Global Regulatory Affairs

🌍 Remote · United States 💼 Full-time

Job Description:

Serve as the regulatory representative on core teams
Develop and plan regulatory submission strategies
Coordinate preparation of submissions to regulatory agencies
Conduct regulatory intelligence activities
Oversee compilation, review, and submission of regulatory applications and submissions, ensuring accuracy, completeness, and timeliness
Monitor the regulatory environment and communicate developments to clinical, regulatory, senior leadership, and other stakeholders
Stay updated on global regulatory guidance and regulations
Communicate key regulatory updates to senior leadership and project team management
Ensure compliance with reporting requirements, including annual and periodic reports
Respond to regulatory questions from authorities in collaboration with clinical development, safety, and other subject matter experts
Provide strategic regulatory guidance for global development and registration programs, including INDs, CTAs, NDAs, and MAAs
Assess and communicate regulatory requirements
Contribute to processes and procedures, including authoring internal work instructions and company SOPs

Requirements:

Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
Established working knowledge of US and international regulatory guidelines and regulations
Demonstrated deep knowledge of the integrated drug development process
Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
Demonstrated ability to assess and manage risk in a highly regulated environment
Strong written, spoken, and presentation communication
Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
Travel expected (10-15%)
Bachelor's degree with 10+ years of relevant drug development experience OR advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience

Benefits:

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