Consultant II

Remotedxb; Dubai; On-site; AED 300,000 - 550,000; Full time

Job summary

Syner-G, a biopharma product development partner, is seeking a regulatory affairs professional to oversee preparation, review and submission of regulatory documents. You will handle FDA meetings and author IND, NDA and BLA submissions, coordinating with clinical teams.

You will mentor junior staff and manage global regulatory communications with FDA and other authorities, supporting clients through development and submission processes.

Qualifications

• 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 CTD structure.
• Experience with protocol development.
• Proven experience handling INDs, NDAs, BLAs, and global submissions.

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.

Skills

Regulatory knowledge

FDA processes

Project management

Education

Bachelor's degree in chemistry, pharmaceutics, biology, or related science

Tools

Microsoft Office Suite

TrackWise

Veeva

ICTD

Job description

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.