Clinical Strategy Consultant

Job Summary

As a Consultant II (Clinical Strategy), the full-time remote position will oversee regulatory compliance and facilitate the development and approval of pharmaceutical products, engaging in all phases of drug development and serving as a strategic partner for clients.

Key Responsibilities

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients
• Engage in all phases of drug development, from early-stage to post-registration, and manage regulatory communications with global authorities
• Mentor and train new employees in regulatory affairs and assist clients with Non-Clinical and Clinical strategy and documentation

Required Qualifications

• Bachelor's degree in chemistry, pharmaceutics, biology, or a related scientific discipline; MA degree preferred
• RAC Certification or equivalent certifications/experience in regulatory affairs is highly valued
• Proficient in Microsoft Office Suite and industry-specific software tools such as Trackwise and Veeva
• Strong understanding of drug development processes and experience with INDs, NDAs, and BLAs
• Demonstrated ability to adapt to client needs and provide strategic advice across various therapeutic areas