Senior Clinical Strategy Consultant

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the creation, examination, and submission of Non-Clinical/Clinical regulatory documents for a diverse range of clients.

• Manage FDA Type A, Type B, Type C, and Type D meetings.

• Participate in all stages of drug development, from initial phases to post-registration.

• Create and evaluate regulatory documents, author IND, NDA, and BLA submissions, while coordinating with Non-Clinical/Clinical teams.

• Support clients in Non-Clinical and Clinical strategy, clinical development endeavors, design, draft submission documents, and review content for thoroughness and quality.

• Oversee and submit forms and documents on a global scale, ensuring adherence to international and regional regulations.

• Lead discussions with FDA representatives, prepare briefing materials, and assist clients in navigating regulatory requirements.

• Conduct research, provide regulatory guidance, and promote marketing efforts through blogs, white papers, and industry involvement.

• Act as the primary contact for clients, ensuring clear communication and regulatory assistance.

• Mentor and train new team members in regulatory affairs, Non-Clinical/Clinical matters, and FDA procedures.

• Facilitate the development, review, and resolution of comments on technically intricate Non-Clinical/Clinical documentation for regulatory submissions.

• Collaborate with clients on Non-Clinical/Clinical strategy and submissions.

• Manage regulatory communications regarding Non-Clinical/Clinical matters with the FDA and other global regulatory bodies.

⛳️ Requirements

• Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific field; a Master's degree is preferred.

• RAC Certification is a notable advantage; equivalent certifications or extensive regulatory affairs experience are highly regarded.

• Skilled in Microsoft Office Suite and industry-specific software tools such as Trackwise, Veeva, and ICTD.

• Strong knowledge of drug development, manufacturing, and clinical development processes.

• Experience in authoring and managing Non-Clinical/Clinical and FDA sections for regulatory submissions.

• Ability to assess manufacturing and quality changes for regulatory implications.

• Proven expertise in regulatory information management systems and tools.

• Familiar with the ICH Common Technical Document (CTD) structure and capable of authoring sections within this framework.

🏝️ Benefits

• Market competitive base salary and annual incentive plan.

• Comprehensive benefit offerings.

• Continuous recognition and career advancement opportunities.

• Generous flexible paid time off program.

• Company-paid holidays.

• Flexible working hours.

• Fully remote work options for most roles.

• Ability to work “almost anywhere.”

• Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.