Regulatory Affairs Senior Associate

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Affairs Senior Associate in the United States.

This role supports the development and execution of regulatory strategies for innovative therapies intended to address serious diseases and unmet medical needs. You will work closely with cross-functional regulatory and clinical teams to prepare, manage, and maintain regulatory submissions and supporting documentation throughout the product lifecycle. The position involves contributing to IND, NDA, and BLA submissions, ensuring compliance with FDA regulations and global regulatory standards. You will also support regulatory research, quality control activities, and communication with health authorities while helping drive operational excellence within regulatory processes. Working in a collaborative and science-driven environment, you will contribute to impactful programs that support the advancement of life-changing therapies. This is an excellent opportunity for a regulatory professional seeking growth within a highly innovative and patient-focused industry.

Accountabilities:

• Support U.S. regulatory activities related to INDs, NDAs, BLAs, amendments, annual reports, and other regulatory submissions.
• Prepare, organize, and maintain regulatory documentation, correspondence, and product history records within regulatory management systems.
• Assist regulatory leads in developing strategic plans, conducting regulatory research, and preparing supporting materials for submissions and agency interactions.
• Coordinate collection, quality review, and submission readiness of regulatory documents and briefing packages.
• Participate in Global Regulatory Team activities, including meeting coordination, documentation, and communication support.
• Manage routine regulatory correspondence, FDA forms, and investigator-initiated study support documentation.
• Contribute to process improvement initiatives, template maintenance, compliance activities, and operational metrics tracking.

Requirements:

• Master’s degree preferred, or equivalent combination of education and regulatory/pharmaceutical industry experience.
• Bachelor’s degree with at least 2 years of regulatory or pharmaceutical experience, or equivalent alternative qualifications.
• Understanding of FDA regulatory processes, submission documentation, and regulatory compliance standards.
• Strong organizational and project coordination skills with the ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication skills with strong attention to detail.
• Ability to work collaboratively within cross-functional global teams in a fast-paced environment.
• Experience with regulatory document management systems and preparation of regulatory submissions is a plus.
• Proactive mindset with strong analytical and problem-solving capabilities.

Benefits:

• Competitive annual salary range: $83,974 – $113,613.
• Comprehensive medical, dental, and vision insurance coverage.
• Retirement and savings plans with generous company contributions.
• Annual bonus opportunities and long-term stock incentive programs (eligibility-based).
• Paid time off, flexible work arrangements, and strong work-life balance support.
• Life insurance, disability coverage, and flexible spending account options.
• Career development programs, collaborative culture, and opportunities to contribute to meaningful healthcare innovation.

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. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1