Associate Director, Regulatory Affairs

Position Overview

Tonix is looking for a full-time Associate Director, Regulatory Affairs to effectively develop regulatory strategies and submission plans. This position would be responsible for leading regulatory activities related mainly for novel biologics or drugs in early phase development (pre-IND and nonclinical experience) to clinical development and marketing application. The Associate Director, Regulatory Affairs can work autonomously and will support all aspects of this process including early phase interactions with regulatory authorities (FDA and/or global), providing direction and actively participating in overall preparation of activities with cross-functional teams to advance the drug development program.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Co-Head of Regulatory Affairs, Management and Execution, and will be based out of a Tonix office or can be a remote based position. 

Key Responsibilities

• Act as Regulatory Lead and Manager for investigational programs in the US or global programs by providing regulatory expertise to advance product development, from nonclinical to clinical and marketing application
• Prepare, review, and co-ordinate regulatory documentation to support early phase development including early phase meetings with Regulatory Authorities and initial IND application and IND amendments to support first-in-human clinical trials
• Manage and prepare complex regulatory submissions, including drafting and review and approval of submission contents, which will require interaction with cross-functional teams and external vendors to ensure timely and quality execution
• Provide regulatory impact assessments to changes to project teams and senior management and recommend strategies and regulatory courses of action
• Follow all established occupational health and safety procedures, GxP and standard operating procedures (SOP’s)
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work as necessary to support the Regulatory function and Tonix on various business initiatives

Qualifications

• Bachelor’s degree in biological or pharmaceutical sciences
• Seven (7) years of experience in pharmaceutical or health care industry experience or equivalent
• Five (5) years in early and late stage regulatory drug development
• Good scientific background and understanding of biology and immunology with the ability to acquire therapeutic area and regulatory knowledge in a short timeframe
• Knowledge of FDA and EU regulations and ICH requirements
• Proven successful leadership and project management experience
• Experience directly writing submission documents that support IND applications, clinical trials, and marketing applications
• Experience developing and implementing regulatory strategies 
• Ability to travel up to 20%
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Strong planning and organizational skills and attention to detail with accuracy and quality
• Excellent written and verbal communication skills
• Able to work independently with minimal supervision and collaboratively with team members
• Able to effectively interact with internal and external parties to drive projects through to completion to tight timelines