Regulatory Affairs Specialist

A company is looking for a Regulatory CMC Author.

Key Responsibilities

Lead the preparation, submission, and maintenance of regulatory documents for clinical trials and drug registration

Provide expertise on regulatory requirements and standards to internal teams

Interface with regulatory agencies to address inquiries and submissions

Required Qualifications

Bachelor's degree in a scientific or related field; advanced degree preferred

3 - 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry

Strong knowledge of global regulatory requirements for clinical trials and product registration

Proven ability to manage regulatory submissions and agency interactions