Senior Associate - Regulatory Affairs

The Senior Associate - Regulatory Affairs role is based in the United States and supports the development and delivery of innovative therapies. Key responsibilities include:

1. Supporting regulatory activities by preparing, reviewing, and submitting regulatory documents.
2. Maintaining regulatory documentation, including product histories, agency communications, submission records, and archival systems.
3. Providing support for regulatory filings such as annual reports, amendments, investigator packages, and other required documentation.
4. Collaborating with cross-functional teams to coordinate regulatory deliverables and ensure compliance with submission requirements.
5. Reviewing regulatory plans and contributing input to operational activities supporting product development strategies.
6. Participating in regulatory strategy discussions and supporting execution of regulatory goals within assigned programs.
7. Contributing to process improvement initiatives, development of regulatory standards, template creation, and operational efficiency improvements.
8. Monitoring regulatory compliance activities and communicating relevant updates, risks, or issues to appropriate teams.

Requirements

• A master’s degree required, or equivalent combination of education and regulatory experience.
• Qualified candidates may have a bachelor’s degree with 2+ years of Regulatory Affairs experience, an associate degree with 6+ years of relevant experience, or a high school diploma/GED with 8+ years of Regulatory Affairs experience.
• A preferred background includes a master’s degree in biology, life sciences, health sciences, or regulatory science with a strong biological focus.
• Experience working in a regulated industry, scientific environment, or clinical setting is highly valued.
• Understanding of regulatory processes, documentation requirements, and compliance standards.
• Strong organizational skills with the ability to manage timelines, priorities, and multiple deliverables.
• Excellent written and verbal communication skills with the ability to collaborate effectively across teams.
• Detail-oriented mindset with strong problem-solving skills and the ability to work independently.
• Experience contributing to process improvements, operational initiatives, or regulatory systems is preferred.

Benefits

• Competitive salary range of $83,974.90 - $113,613.10 USD per year, depending on skills, experience, qualifications, and location.
• Comprehensive employee benefits package, including medical, dental, and vision coverage.
• Retirement and savings plans with company contributions.
• Life and disability insurance coverage.
• Flexible spending accounts.
• Annual bonus programs.
• Long-term incentive opportunities through stock-based rewards.
• Generous paid time off programs.
• Flexible work models where applicable.
• Career development opportunities and support for professional growth.
• Opportunity to contribute to meaningful healthcare innovations that impact patients worldwide.