Regulatory Affairs Specialist
VirtualVocationsLowell, Massachusetts, United Statesjob_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_description
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
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Regulatory Specialist • Lowell, Massachusetts, United States
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