This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Senior Associate based in United States.
This role is part of a highly regulated, science-driven environment focused on supporting the development and approval of innovative therapies for patients with serious and life-threatening conditions. You will contribute directly to the preparation, coordination, and submission of critical regulatory documentation that enables clinical development and product approvals. Working closely with senior regulatory leads, you will help ensure compliance with U.S. FDA requirements while supporting global regulatory strategy execution. The position combines hands-on regulatory operations, documentation management, and cross-functional collaboration across global teams. You will also contribute to process improvement initiatives and help maintain high standards of regulatory quality and consistency. This is a mission-driven role where precision, scientific rigor, and collaboration directly impact patient access to life-changing treatments.
Accountabilities
- Support US Regulatory Leads in the preparation and submission of key regulatory applications, including INDs, BLAs, and NDAs
- Assist in the creation, maintenance, and lifecycle management of regulatory documentation such as annual reports, amendments, and agency correspondence
- Ensure accurate archiving and management of regulatory records and maintain product regulatory history documentation systems
- Contribute to regulatory strategy development by performing research and supporting updates to Global Regulatory Strategic Plans (GRSP)
- Coordinate cross-functional input and documentation required for regulatory submissions and agency communications
- Support FDA interaction processes, including preparation of responses to agency queries and regulatory correspondence
- Participate in global regulatory teams and assist with meeting coordination, agendas, and documentation of outcomes
- Perform quality checks on regulatory deliverables, including briefing packages and submission components
- Draft routine regulatory documents, forms, and cross-reference letters supporting clinical and investigator-initiated studies
- Contribute to continuous improvement initiatives, including template development, standards enhancement, and process optimization
Requirements
- Bachelor’s degree with 2+ years of regulatory or pharmaceutical experience, or equivalent combination of education and experience
- Strong understanding of regulatory affairs processes, ideally within biotech, pharma, or highly regulated healthcare environments
- Experience supporting regulatory submissions or documentation for FDA or similar health authorities
- Familiarity with IND, BLA, and NDA processes (or equivalent regulatory frameworks)
- Strong attention to detail with the ability to manage complex documentation and ensure compliance standards
- Excellent organizational skills with the ability to manage multiple priorities in a deadline-driven environment
- Strong written and verbal communication skills for regulatory documentation and cross-functional collaboration
- Ability to work effectively within global, cross-functional teams including regulatory, clinical, and quality functions
- Experience with regulatory document management systems is a plus
- Proactive mindset with willingness to support continuous improvement and operational excellence initiatives
Benefits
- Competitive annual salary ranging from $83,974.90 to $113,613.10 depending on experience and qualifications
- Comprehensive medical, dental, and vision insurance coverage
- Retirement and savings plans with employer contributions
- Annual bonus program and long-term incentive opportunities
- Flexible work arrangements where applicable
- Paid time off, holiday programs, and well-being initiatives
- Life and disability insurance coverage
- Strong career development and training opportunities within a global organization
- Inclusive and collaborative work environment focused on scientific innovation and patient impact