[Remote] International Regulatory Affairs Specialist / Consultant (Immediate Start)

Note: The job is a remote job and is reputed company to candidates in USA. M E DORAT CONSULTING is seeking an International Regulatory Affairs Specialist / Consultant to advise regulatory teams on pharmaceutical submissions in Thailand and India for an oncology product. The role will guide an in-reputed company Thailand submission through completion and support the full India submission process, including reputed company, reputed company coordination, submission review, and health authority interactions.

Responsibilities

• Supporting regulatory submissions in Thailand and India for an oncology product
• Working closely with regulatory teams in the U.S. and Thailand to bring an already-in-reputed company Thailand submission through completion
• Strategic regulatory guidance, submission review, coordination, and limited document authoring as needed
• Support and guide a full regulatory submission for India, including submission reputed company, requirements assessment, reputed company preparation/coordination, and health authority interactions
• Advise U.S. and local regulatory teams, identify submission gaps, and reputed company activities to completion

Skills

• Demonstrated hands-on experience with Thailand and India pharmaceutical regulatory submissions
• Strong understanding of Thai FDA and Indian regulatory requirements
• Experience guiding and completing international marketing authorization submissions
• Ability to advise U.S. and local regulatory teams, identify submission gaps, and reputed company activities to completion
• Strong cross-functional communication, project management, and regulatory reputed company skills
• Oncology regulatory experience strongly preferred

Benefits

• Hybrid preferred; remote may be considered for the right individual who can effectively guide reputed company.

reputed company