Associate Director, Regulatory Affairs
Tonix Pharmaceuticals, Berkeley Heights, NJ, United States
Position Overview
Tonix is looking for a full‑time Associate Director, Regulatory Affairs to develop regulatory strategies and submission plans. This position will be responsible for leading regulatory activities related mainly to novel biologics or drugs in early‑phase development (pre‑IND and nonclinical experience) to clinical development and marketing application. The Associate Director will support all aspects of this process, including early‑phase interactions with regulatory authorities (FDA and/or global), providing direction and actively participating with cross‑functional teams to advance the drug development program.
This fast‑paced, challenging role reports directly to the Co‑Head of Regulatory Affairs, Management and Execution and is based in the Tonix office or may be remote.
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 coordinate 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, requiring interaction with cross‑functional teams and external vendors to ensure timely and quality execution.
Provide regulatory impact assessments of 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 (SOPs).
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 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.
Skills and Abilities
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 within tight timelines.
Ability for travel 20% of the time.
Salary Range $190,000 – $200,000 USD
Please note that Tonix does not offer sponsorship for this role.
Equal Employment Opportunity Statement Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
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This fast‑paced, challenging role reports directly to the Co‑Head of Regulatory Affairs, Management and Execution and is based in the Tonix office or may be remote.
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 coordinate 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, requiring interaction with cross‑functional teams and external vendors to ensure timely and quality execution.
Provide regulatory impact assessments of 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 (SOPs).
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 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.
Skills and Abilities
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 within tight timelines.
Ability for travel 20% of the time.
Salary Range $190,000 – $200,000 USD
Please note that Tonix does not offer sponsorship for this role.
Equal Employment Opportunity Statement Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
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