Associate Director, Regulatory Affairs
- Expired: over a month ago. Applications are no longer accepted.
Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS), immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19.
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 to biologics (large molecule/vaccines programs) in early phase development (pre-IND) to clinical development and marketing application. The Associate Director, Regulatory Affairs will support all aspects of this process including providing direction and actively participating in overall preparation of activities 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 Director of Regulatory Affairs and will be based out of a Tonix office or can be a remote based position.
- Participate as the regulatory Lead on teams and represent Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development, particularly regulatory strategy in biologics in the US for rare disease, vaccine, immunological indications
- Develop and execute regulatory strategy for one or more biologic, and may include drug and/or delivery device
- Assure connectivity to the overall regulatory strategy through partnership and communication with cross-functional internal and external teams
- Prepare and/or oversee complex regulatory submissions which require interaction with cross-functional teams to ensure optimal execution
- Prepare, review, and/or co-ordinate regulatory documentation to support early phase development including initial IND application/amendments to support first-in-human clinical trials
- Prepare, review, and/or co-ordinate submissions for assigned project(s) in line with ICH requirements, FDA requirements, and scientific and company policies and procedures
- Provide accurate regulatory assessments of changes to teams and projects and execute regulatory planning and implementation
- Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
- Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives
- Recruits, interviews, hires, and trains new staff
- Oversees the daily workflow of the department
- Provides constructive and timely performance evaluations
- If necessary, handles discipline and termination of employees in accordance with company policy
- Contributes to performance and compensation decisions such as: merit raises, bonuses, and promotions
- Bachelor’s in biological or pharmaceutical sciences with seven (7) years of experience in pharmaceutical or health care industry experience or equivalent preferred
- Solid understanding of biology relevant to pharmaceutical industry
- Five (5) years in biologics, in early and late-stage regulatory drug development
- Proven successful leadership and project management experience
- Experience directly writing submission documents that support IND applications, clinical trials, and marketing applications
- Knowledge of FDA and EU regulations
- Experience developing and implementing regulatory strategy
- Good scientific background and understanding with the ability to acquire therapy area and regulatory knowledge in a short timeframe
- Critical thinking on current global regulatory science questions and a good understanding of the corresponding scientific and clinical components
- Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills
- Strategic thinking skills with ability to facilitate/impact and influence effective planning interactions and discussions
- Attention to detail with accuracy and quality
- Able to effectively interact with external parties to information gather and drive projects through to completion to tight timelines
- Ability for travel 20% of the time
- Dedicated team player who is able to withstand the high demands of a fast-paced environment
- Excellent written and verbal communication skills are essential
- Strong planning and organizational skills
- Highly motivated and comfortable working independently with minimal supervision
- Highly organized, results driven, problem solver, and collaborator
- Demonstrated ability to perform the essential duties of the position with or without accommodation
Tonix offers salary commensurate with experience and an excellent benefits package.
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.
Please include any additional information that our Talent Acquisition Team should be aware of to help you fill the role (I.e.: experience more important to me than education, willing to look for candidates outside of the ideal location)
Tonix Pharmaceuticals Inc
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