Regulatory Affairs Consultant

Summary

Join Syner-G BioPharma Group and Sequoia Biotech Consulting, a leading life sciences consultancy, as a Regulatory Affairs Consultant, Regulatory Strategy. Guide clients through regulatory processes, particularly in clinical development and application filings. Coordinate meetings, guide authors, and serve as a primary point of contact with regulatory agencies. Work cross-functionally with various teams to ensure timely filing and successful regulatory approval of therapeutic agents. This remote-eligible position offers domestic and international travel opportunities (up to 20%). The company values its employees and offers a competitive salary, benefits, and career development opportunities.

Requirements

• Hold at least a Bachelor’s degree in a scientific field
• 6+ years of experience in regulatory affairs, including agency interactions, submission and project management and regulatory planning
• Experience in supporting teams in filing of INDs/CTAs and NDAs/BLA/MAAs
• Expertise across all phases of drug development, including biologics, pharmaceuticals, oncology, orphan drugs, and pediatric studies
• Strong research skills to stay current with changing regulations and locate relevant resources
• Knowledge of FDA regulations, international guidelines, and the ability to advise on fast-track analysis, pediatric studies, and emergency inquiries
• Proficiency in Microsoft Office applications, particularly Excel and PowerPoint
• Strong communication skills, with the ability to mentor, educate, and influence a diverse group of stakeholders
• Ability to work in a fast-paced, dynamic environment, managing multiple projects and clients while ensuring regulatory compliance and alignment with business goals
• Experience in supporting and developing strategies and participating in Health Authority interactions

Responsibilities

• Guide clients on decisions, agency meetings, and regulatory filings, with emphasis on clinical development
• Oversee INDs, CTAs, application filings, and approvals for various clients, including significant applications for clinical supplies and trials
• Handle FDA meetings, prepare clients, resolve questions, and develop/execute data driven strategies
• Engage in multiple phases of drug development, from early-stage to post-registration, ensuring client needs are met
• Develop and review regulatory documents, authoring NDA, BLA submissions, and coordinating with medical writing, CMC, quality, nonclinical, and technical teams
• Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines
• Lead meetings with FDA representatives, prepare briefing documents, and assist clients in navigating regulatory requirements
• Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement
• Mentor and train new employees, providing guidance on systems, software, and regulatory processes
• Collaborate across departments and with client teams, ensuring alignment on project goals and regulatory strategies
• Maintain continuous education on regulatory updates and new releases, contributing to team knowledge and industry best practices

Preferred Qualifications

• Master's degree in a scientific field
• RAC certification

Benefits

• Market competitive base salary and annual incentive plan
• Robust benefit offerings
• Ongoing recognition and career development opportunities
• Generous flexible paid time off program
• Company paid holidays
• Flexible working hours
• Fully remote work options for most positions and the ability to work “almost anywhere”