Remote Regulatory Affairs Specialist

Shape Compliance. Drive Innovation. Influence Global Impact.

Are you ready to make a real difference in regulatory compliance while working remotely? We are seeking a Remote Regulatory Affairs Specialist who is passionate about helping businesses navigate complex regulatory landscapes. This role offers you the chance to lead strategic compliance initiatives, ensure timely regulatory approvals, and collaborate cross-functionally to bring innovative products to global markets.

Position Overview

As a Regulatory Affairs Specialist working remotely, you will support regulatory processes that impact domestic and international operations. This is an opportunity to elevate your career while enabling a company’s global compliance posture. Your insight into industry standards, evolving regulations, and quality assurance frameworks will drive our mission to deliver safe, ethical, and compliant products worldwide.

With a professional yet flexible environment, this role provides a gateway to influence policy, lead change, and serve as a regulatory voice at the strategic table.

Key Responsibilities

• Collaborate with internal teams to prepare, review, and submit regulatory filings for product approvals, renewals, and changes.
• Monitor regulatory trends and changes across key markets (FDA, EMA, TGA, etc.)
• Interpret regulations and provide guidance for product development and marketing strategies.
• Conduct risk assessments and regulatory impact analysis for new and existing products.
• Maintain a comprehensive database of global compliance documentation and regulatory intelligence.
• Ensure timely communication and responses to regulatory agencies and partners.
• Develop internal training and SOPs related to regulatory requirements
• Partner with R&D, quality assurance, and legal teams to align regulatory activities with company goals

Work Environment

Professional Remote Culture

• Independence in managing your workflow with trust and accountability
• Supportive leadership that encourages feedback and continuous improvement
• A culture built on integrity, transparency, and mutual respect

Virtual Team Collaboration

• Regular team huddles to share insights and brainstorm cross-functional solutions
• Work-from-home tools that support document control, regulatory tracking, and communication

Tools and Technology

Our tech stack enables innovative, seamless regulatory collaboration:

• Veeva Vault for regulatory document management
• MasterControl and TrackWise for compliance monitoring
• Microsoft Teams and Zoom for remote meetings and project coordination
• Jira and Confluence for cross-departmental alignment
• Regulatory databases and tools like FDA eSubmitter and EU CESP

Qualifications for Success

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or related discipline (Master’s or RAC certification is a plus)
• 3+ years of experience in regulatory affairs, with a focus on remote compliance operations
• Strong working knowledge of FDA, EMA, and global regulatory standards
• Experience in regulatory submission formats such as eCTD, CE Marking, and labeling regulations
• Proficiency in compiling, editing, and submitting high-quality technical documents
• Ability to interpret complex regulatory policies and translate them into actionable guidance
• Excellent communication and time management skills to balance multiple projects remotely
• Analytical mindset with a proactive approach to risk mitigation and problem-solving

Career Growth and Impact

Your Role in Our Success

• Champion new market entries by ensuring product approvals are fast, efficient, and strategic
• Participate in thought leadership by contributing to regulatory strategy development.
• Lead cross-functional initiatives that refine processes and reduce compliance risks.

Development Opportunities

• Grow professionally with access to industry certifications, mentorship, and leadership development.
• Be recognized for contributions, celebrate milestones, and follow clear pathways for advancement

Why You Should Apply

• Make a tangible impact by guiding products to market safely and ethically
• Join a visionary team that values both precision and innovation
• Expand your global regulatory expertise while enjoying work-life flexibility
• Thrive in a purpose-driven role that’s both strategic and technical
• Work in an environment where compliance isn’t just a requirement — it’s a shared value

Compensation and Benefits

Salary Information

• Annual Salary: $95,411

Take the Next Step

If you’re looking to shape your regulatory career while contributing to a broader mission, this opportunity is for you. Use your expertise to champion compliance and innovation from wherever you are. Apply now and help us set the global standard in regulatory excellence.