Sr. Regulatory Affairs Specialist at Jobgether – United States

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

This role provides a pivotal opportunity to support global regulatory strategies and ensure compliance across multiple regions, including EMEA, LATAM, and APAC. You will coordinate, author, and review regulatory submissions, working closely with cross-functional teams in clinical, manufacturing, and research areas. The position requires staying current with international regulations and guidelines, assessing their impact, and providing actionable recommendations. You will contribute to regulatory strategy execution, maintain accurate documentation, and act as a key liaison across projects to ensure timelines and quality standards are met. This is a high-visibility role ideal for professionals who thrive in a fast-paced, detail-oriented, and collaborative environment, with the chance to make a meaningful impact on global health outcomes.

• Coordinate, prepare, and submit regulatory documents for multiple international regions, ensuring compliance with local requirements
• Review documentation from clinical, pre-clinical, research, development, and manufacturing functions for consistency with regulatory standards
• Maintain up-to-date knowledge of global regulatory requirements and assess the impact of changes on assigned projects
• Support the development and execution of regulatory strategies in collaboration with senior Regulatory Affairs personnel
• Participate in cross-functional project teams, integrating regulatory considerations into project planning and execution
• Maintain accurate and organized regulatory records, including submission archives and correspondence with agencies
• Independently manage routine assignments while following guidance on complex or new tasks

• Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, or related field)
• Minimum of 5 years of regulatory affairs experience in biotechnology, pharmaceutical, or medical device industries
• Proven ability to manage multiple priorities and meet deadlines in a fast-paced environment
• Strong written and verbal communication skills, with attention to interpersonal collaboration
• Highly detail-oriented and committed to accuracy and quality in regulatory documentation
• Effective time management, organizational skills, and ability to take initiative and work independently

• Competitive base salary: $150,000 – $165,000 annually
• Comprehensive medical, dental, and vision coverage, including domestic partner benefits
• Paid maternity and paternity leave
• Flexible spending accounts for healthcare and dependent care
• Life and accidental death insurance, short- and long-term disability coverage
• 401(k) retirement plan with company match and RSUs
• Employee Assistance Program (EAP), legal and financial services, health club discounts, and tuition reimbursement