Associate Director, Regulatory Affairs
Tonix Pharmaceuticals
6 hours ago
Remote friendly (Berkeley Heights, NJ)
United States
Corporate Functions
Associate Director, Regulatory Affairs
Responsibilities:
- Act as Regulatory Lead/Manager for investigational US and global programs, providing regulatory expertise from nonclinical through clinical and marketing application
- Prepare, review, and coordinate regulatory documentation to support early-phase development, including regulatory authority meetings and initial IND applications and IND amendments for first-in-human trials
- Manage and prepare complex regulatory submissions, including drafting/review/approval of submission content, working with cross-functional teams and external vendors
- Provide regulatory impact assessments for project team changes and senior management; recommend regulatory strategies/courses of action
- Follow occupational health and safety procedures, GxP, and SOPs
- Uphold company mission/values (accountability, innovation, integrity, quality, teamwork)
- Perform ad-hoc regulatory/function support for business initiatives as needed
Qualifications:
- Bachelor’s in biological or pharmaceutical sciences
- 7 years of pharmaceutical/health care industry experience (or equivalent)
- 5 years in early and late stage regulatory drug development
- Good scientific background in biology/immunology; ability to acquire therapeutic area and regulatory knowledge quickly
- Knowledge of FDA and EU regulations and ICH requirements
- Proven leadership and project management experience
- Experience directly writing IND/clinical trial/marketing application submission documents
- Experience developing and implementing regulatory strategies
Skills and Abilities:
- Strong planning/organizational skills and attention to detail
- Excellent written and verbal communication
- Ability to work independently and collaboratively
- Ability to manage interactions with internal/external parties to meet tight timelines
- Travel ~20%
Compensation & Benefits:
- Medical, dental, vision; life/AD&D; short/long-term disability; flexible spending; health savings; employee assistance
- Pet insurance
- 401(k) with company match and annual discretionary stock options
- Paid time off, sick time, and paid holidays
- Career development and training
Application instructions:
- Tonix does not offer sponsorship for this role.
Responsibilities:
- Act as Regulatory Lead/Manager for investigational US and global programs, providing regulatory expertise from nonclinical through clinical and marketing application
- Prepare, review, and coordinate regulatory documentation to support early-phase development, including regulatory authority meetings and initial IND applications and IND amendments for first-in-human trials
- Manage and prepare complex regulatory submissions, including drafting/review/approval of submission content, working with cross-functional teams and external vendors
- Provide regulatory impact assessments for project team changes and senior management; recommend regulatory strategies/courses of action
- Follow occupational health and safety procedures, GxP, and SOPs
- Uphold company mission/values (accountability, innovation, integrity, quality, teamwork)
- Perform ad-hoc regulatory/function support for business initiatives as needed
Qualifications:
- Bachelor’s in biological or pharmaceutical sciences
- 7 years of pharmaceutical/health care industry experience (or equivalent)
- 5 years in early and late stage regulatory drug development
- Good scientific background in biology/immunology; ability to acquire therapeutic area and regulatory knowledge quickly
- Knowledge of FDA and EU regulations and ICH requirements
- Proven leadership and project management experience
- Experience directly writing IND/clinical trial/marketing application submission documents
- Experience developing and implementing regulatory strategies
Skills and Abilities:
- Strong planning/organizational skills and attention to detail
- Excellent written and verbal communication
- Ability to work independently and collaboratively
- Ability to manage interactions with internal/external parties to meet tight timelines
- Travel ~20%
Compensation & Benefits:
- Medical, dental, vision; life/AD&D; short/long-term disability; flexible spending; health savings; employee assistance
- Pet insurance
- 401(k) with company match and annual discretionary stock options
- Paid time off, sick time, and paid holidays
- Career development and training
Application instructions:
- Tonix does not offer sponsorship for this role.