Senior Specialist, Regulatory Operations

Benefits

Qualifications

• •Skilled at balancing strategic oversight with hands-on execution
• •Strong communicator and collaborator with excellent organizational skills
• •Ability to travel 10% of the time
• •Bachelor's degree in a scientific or related field
• •3-4 years of regulatory operations experience in biotech or pharmaceutical industry
• •Strong understanding of eCTD submission standards and regulatory requirements across global regions
• •Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management
• •4 more items(s)

Responsibilities

• •Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication
• •The Senior Specialist, Regulatory Operations, will be responsible for submission management across the development pipeline and support the commercial portfolio
• •This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases
• •You'll work closely with Regulatory Affairs and cross-functional partners to manage timelines, ensure submission readiness, and strengthen operational excellence across the organization
• •This position will report directly to the Senior Director of Regulatory Affairs and will be based out of a Tonix office or can be a remote based position
• •Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables
• •This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities
• •Serve as submission manager and primary contact for publishing vendors and internal stakeholders
• •Oversee regulatory document management, tracking, and archival activities
• •Manage regulatory systems (e.g., Veeva RIM, PromoMats), and serve as internal subject matter expert (SME) for training and support to internal stakeholders
• •Develop and implement processes, templates, and tools that improve submission efficiency and consistency
• •Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases
• •Provide subject matter expertise on regulatory technologies and submission best practices
• •Monitor new regulations and industry trends to assess impact on operational practices
• •Any other supporting activities or research, as needed, for the regulatory team
• •12 more items(s)