Senior Clinical Strategy Consultant

Job Summary

Guiding clients through the complex landscape of regulatory affairs, the full-time Senior Clinical Strategy Consultant will oversee the preparation and submission of regulatory documents, manage FDA meetings, and engage in all phases of drug development while working remotely.

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
• Serve as the main point of contact for clients, ensuring effective communication and regulatory support

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, manufacturing, and clinical development processes
• Proven experience in handling INDs, NDAs, BLAs, and global submissions