Consultant II

Responsibilities

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents
• Handle FDA Type A, Type B, Type C and Type D meetings
• Author IND, NDA and BLA submissions and coordinate with clinical teams
• Assist clients with clinical development activities, design, and drafting submission documents
• Manage and submit regulatory forms and documents globally
• Serve as the main point of contact for clients regarding regulatory support
• Mentor and train new employees in regulatory affairs and FDA processes
• Manage regulatory communications with the FDA and other global authorities

Requirements

• Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific discipline
• Proficiency in Microsoft Office Suite, Trackwise, Veeva, and ICTD
• Strong understanding of drug development, manufacturing, and clinical development processes
• Experience authoring and managing Non-Clinical/Clinical and FDA sections for regulatory submissions
• Familiarity with ICH Common Technical Document (CTD) structure
• Experience with protocol development
• Proven experience handling INDs, NDAs, BLAs, and global submissions

Preferred Qualifications

• MA degree in a related scientific discipline
• RAC Certification

About the Company

Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and the delivery of life-enhancing therapies to patients.