Senior Associate Specialist, Regulatory Operations

Accountabilities:
The Senior Associate Specialist, Regulatory Operations will support regulatory submission activities by ensuring accurate preparation, organization, and delivery of regulatory materials. The role requires strong attention to detail, ownership of regulatory systems, and collaboration across scientific and operational teams to keep programs moving efficiently. Assist with the preparation, review, formatting, and organization of clinical and CMC regulatory submissions and reports. Compile and package regulatory submissions using electronic submission platforms, ensuring accuracy and compliance with requirements. Assemble, publish, and submit regulatory documentation to relevant agencies, including technical sections, amendments, annual reports, meeting requests, and related correspondence. Manage electronic submission processes, including account administration, submission tracking, receipt reconciliation, and troubleshooting transmission issues. Maintain regulatory archives, correspondence logs, and documentation systems to ensure information can be quickly accessed during review cycles or inspections. Own regulatory document templates, formatting standards, and submission style guidelines. Create and maintain submission trackers while ensuring regulatory activity records remain accurate and up to date. Collaborate with Research, Clinical Development, CMC, and other cross-functional teams to coordinate submission content and timelines. Support product labeling activities and regulatory documentation requirements. Monitor regulatory updates and evolving requirements from relevant authorities to ensure continued compliance. Independently manage assigned regulatory operations activities while aligning with broader regulatory strategies and priorities. Requirements: The ideal candidate has hands-on regulatory operations experience and understands the requirements involved in preparing and submitting regulatory documentation. Successful candidates will combine technical knowledge, organizational skills, and the ability to collaborate effectively across multidisciplinary teams. Bachelor’s degree in biology, veterinary medicine, regulatory affairs, life sciences, or a related field; relevant professional experience may be considered in place of a specific degree. 3–5 years of regulatory operations experience within human health, animal health, biotechnology, pharmaceuticals, or related industries. Experience preparing, formatting, packaging, and submitting regulatory documentation. Hands-on experience with electronic regulatory submission systems, including FDA electronic submission processes. Knowledge of regulatory submission types and processes, including IND/INAD, NDA/NADA, biologics submissions, meeting requests, supplements, and related filings. Understanding of regulatory documentation standards and submission lifecycle management. Experience collaborating with cross-functional teams, including Research, Clinical Development, CMC, and Regulatory Affairs. Ability to manage multiple priorities, maintain accurate records, and meet deadlines in a dynamic environment. Strong attention to detail with excellent organizational and documentation skills. Ability to work independently, take ownership of responsibilities, and make informed decisions within established frameworks. Familiarity with international regulatory submissions is preferred. Regulatory Affairs Professionals Society (RAPS) certification is a plus but not required. Passion for contributing to innovative regulatory programs and emerging healthcare solutions. Benefits: The role offers a competitive compensation package and benefits designed to support employees’ health, development, flexibility, and overall well-being. Competitive annual salary range of $110,000 - $160,000. Company equity options grant for new hires. Full health insurance coverage, including medical, dental, and vision plans for employees and dependents. $1,000 home office equipment stipend. $1,200 annual learning and development budget for books, courses, and professional growth. $250 monthly wellness budget for eligible personal wellness expenses. Extended weekends with all three-day weekends converted into four-day weekends. Unlimited vacation policy and paid holidays. Paid leave opportunity for employees who adopt a dog. Remote work flexibility and a collaborative, mission-driven environment. Opportunities to contribute to innovative programs creating new possibilities in healthcare.

How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
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