Senior Regulatory Affairs Associate
Tonix Pharmaceuticals
9 hours ago
Remote friendly (Chatham, NJ)
United States
Corporate Functions
Position Overview
Senior Specialist, Regulatory Operations: Responsible for submission management across the development pipeline and support the commercial portfolio. Hands-on role assisting regulatory affairs systems, applications, and tools (system implementations, maintenance, updates, and releases). Works with Regulatory Affairs and cross-functional partners to manage timelines and submission readiness. Reports to the Senior Director of Regulatory Affairs; office-based or remote.
Essential Duties
- Lead end-to-end management of regulatory submissions, ensuring timely, compliant, high-quality deliverables.
- Interface with external publishing vendors and internal stakeholders to provide operational oversight/support for eCTD regulatory submissions.
- Serve as submission manager and primary contact for publishing vendors and internal stakeholders.
- Oversee regulatory document management, tracking, and archival.
- Manage regulatory systems (e.g., Veeva RIM, PromoMats); act as internal SME for training/support.
- Develop and implement processes, templates, and tools to improve submission efficiency/consistency.
- Partner with IT to maintain regulatory technology landscape (maintenance, updates, releases).
- Provide regulatory technology and submission best-practices expertise.
- Monitor new regulations/industry trends and assess impact on operational practices.
- Perform other supporting activities/research as needed.
Necessary Skills/Abilities
- Experience managing outsourced publishing vendors (plus).
- Balance strategic oversight with hands-on execution.
- Strong communication/collaboration and organizational skills.
- Ability to travel 10%.
Educational Requirements
- Bachelor’s degree in a scientific or related field.
Experience Requirements
- 3–4 years regulatory operations experience in biotech/pharma.
- Strong understanding of eCTD standards and global regulatory requirements.
- Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management.
- Hands-on Veeva RIM and/or PromoMats strongly preferred.
Compensation & Benefits
- Medical, dental, vision, life/AD&D, short-/long-term disability, FSAs, HSA, Employee Assistance Programs; pet insurance; 401k with company match and annual discretionary stock options; paid time off, sick time, paid holidays; career development/training.
Application Instructions
- Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition.
Senior Specialist, Regulatory Operations: Responsible for submission management across the development pipeline and support the commercial portfolio. Hands-on role assisting regulatory affairs systems, applications, and tools (system implementations, maintenance, updates, and releases). Works with Regulatory Affairs and cross-functional partners to manage timelines and submission readiness. Reports to the Senior Director of Regulatory Affairs; office-based or remote.
Essential Duties
- Lead end-to-end management of regulatory submissions, ensuring timely, compliant, high-quality deliverables.
- Interface with external publishing vendors and internal stakeholders to provide operational oversight/support for eCTD regulatory submissions.
- Serve as submission manager and primary contact for publishing vendors and internal stakeholders.
- Oversee regulatory document management, tracking, and archival.
- Manage regulatory systems (e.g., Veeva RIM, PromoMats); act as internal SME for training/support.
- Develop and implement processes, templates, and tools to improve submission efficiency/consistency.
- Partner with IT to maintain regulatory technology landscape (maintenance, updates, releases).
- Provide regulatory technology and submission best-practices expertise.
- Monitor new regulations/industry trends and assess impact on operational practices.
- Perform other supporting activities/research as needed.
Necessary Skills/Abilities
- Experience managing outsourced publishing vendors (plus).
- Balance strategic oversight with hands-on execution.
- Strong communication/collaboration and organizational skills.
- Ability to travel 10%.
Educational Requirements
- Bachelor’s degree in a scientific or related field.
Experience Requirements
- 3–4 years regulatory operations experience in biotech/pharma.
- Strong understanding of eCTD standards and global regulatory requirements.
- Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management.
- Hands-on Veeva RIM and/or PromoMats strongly preferred.
Compensation & Benefits
- Medical, dental, vision, life/AD&D, short-/long-term disability, FSAs, HSA, Employee Assistance Programs; pet insurance; 401k with company match and annual discretionary stock options; paid time off, sick time, paid holidays; career development/training.
Application Instructions
- Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition.