Senior Regulatory Operations AssociateVirtualVocations • Lowell, Massachusetts, United States
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Senior Regulatory Operations Associate
VirtualVocations • Lowell, Massachusetts, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
A company is looking for a Senior, Regulatory Operations Associate (TEMP) to join their Regulatory Operations team.
Key Responsibilities
Format and ensure compliance of submission level documents for electronic submissions
Coordinate and publish components of various Regulatory Agency submissions
Participate in the interpretation of health agency guidelines and lead projects to improve department processes
Required Qualifications
Bachelor's degree in Science / Technology or equivalent experience
6+ years of experience in Regulatory Operations within the pharmaceutical or biotech industry
Advanced skills in Microsoft Office Word, Adobe Professional, and relevant tools
Proficiency in eCTD publishing tools such as docuBridge or Global Submit
Current knowledge of global regulatory submission requirements and industry legislation
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Senior Associate • Lowell, Massachusetts, United States
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