Associate Director Regulatory Affairs
Tonix Pharmaceuticals
9 hours ago
Remote friendly (Berkeley Heights, NJ)
United States
Corporate Functions
Position Overview
- Full-time Associate Director, Regulatory Affairs. Lead regulatory activities for novel biologics (large molecule/infectious disease, autoimmune disease programs) from pre-IND/nonclinical through clinical development and marketing application.
- Work autonomously; support early phase interactions with regulators (FDA and/or global) and collaborate with cross-functional teams.
Essential Duties
- Act as Regulatory Lead for US biologics programs (infectious disease, immunological/autoimmune).
- Prepare/review/co-ordinate regulatory documentation; lead early phase meetings and IND application/IND amendments for first-in-human trials.
- Manage complex regulatory submissions (drafting, review, approvals) with cross-functional teams and external vendors.
- Provide regulatory impact assessments and recommend regulatory strategy/course of action.
- Follow occupational health & safety procedures, GxP, and SOPs.
- Perform ad-hoc regulatory work to support business initiatives.
Minimum Qualifications / Skills
- Bachelor’s in biological-related subjects or pharmaceutical sciences.
- 5+ years in biologics regulatory drug development (early and late stage).
- Strong biology/immunology understanding; ability to rapidly learn therapeutic area and regulatory requirements.
- Knowledge of FDA/EU regulations and ICH.
- Leadership/project management experience.
- Direct experience writing IND/clinical trial/marketing application submission documents.
- Experience developing and implementing regulatory strategies.
- Strong planning/organizational skills and attention to detail; excellent written/verbal communication.
- Ability to work independently and collaborate; interact with internal/external parties; travel ~20%.
Compensation & Benefits
- Annual base salary: $130,000–$200,000 plus target incentive.
- Medical/Dental/Vision; life/AD&D; short/long-term disability; FSAs; HSA; EAP; pet insurance; 401(k) match and stock options; paid time off/sick time/holidays; career development & training.
Application Instructions
- Do not forward resumes to employees or other locations; Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition.
- Full-time Associate Director, Regulatory Affairs. Lead regulatory activities for novel biologics (large molecule/infectious disease, autoimmune disease programs) from pre-IND/nonclinical through clinical development and marketing application.
- Work autonomously; support early phase interactions with regulators (FDA and/or global) and collaborate with cross-functional teams.
Essential Duties
- Act as Regulatory Lead for US biologics programs (infectious disease, immunological/autoimmune).
- Prepare/review/co-ordinate regulatory documentation; lead early phase meetings and IND application/IND amendments for first-in-human trials.
- Manage complex regulatory submissions (drafting, review, approvals) with cross-functional teams and external vendors.
- Provide regulatory impact assessments and recommend regulatory strategy/course of action.
- Follow occupational health & safety procedures, GxP, and SOPs.
- Perform ad-hoc regulatory work to support business initiatives.
Minimum Qualifications / Skills
- Bachelor’s in biological-related subjects or pharmaceutical sciences.
- 5+ years in biologics regulatory drug development (early and late stage).
- Strong biology/immunology understanding; ability to rapidly learn therapeutic area and regulatory requirements.
- Knowledge of FDA/EU regulations and ICH.
- Leadership/project management experience.
- Direct experience writing IND/clinical trial/marketing application submission documents.
- Experience developing and implementing regulatory strategies.
- Strong planning/organizational skills and attention to detail; excellent written/verbal communication.
- Ability to work independently and collaborate; interact with internal/external parties; travel ~20%.
Compensation & Benefits
- Annual base salary: $130,000–$200,000 plus target incentive.
- Medical/Dental/Vision; life/AD&D; short/long-term disability; FSAs; HSA; EAP; pet insurance; 401(k) match and stock options; paid time off/sick time/holidays; career development & training.
Application Instructions
- Do not forward resumes to employees or other locations; Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition.