Regulatory Publisher/Regulatory Operations Specialist

Responsibilities and Qualifications

• Responsible for the preparation of documents for publishing, compilation, and QC of regulatory submissions to Regulatory Health Authorities (e.g., FDA and EMA), including but not limited to IND, BLA/NDA/MAA, IND amendments, meeting requests and briefing books
• Knowledgeable of eCTD templates and structure of Modules (1-5)
• Word formatting, PDF publishing and eCTD backbone compilation of regulatory submissions
• Assures completeness and quality of submissions from the operations perspective
• Identifies issues, suggests and implements solutions
• Properly archives regulatory submissions
• Knowledge of current regulations, laws and guidance, both US and ex-US
• Responsible for interaction with team members across a number of development programs
• Keeps track of and manages timelines

Teamwork

• Interfaces with project managers, regulatory leads, and/or content authors to provide technical guidance and support in finalizing submission content
• Promotes and demonstrates collegiality with all firm members
• Participates in the training and development programs

Education and Skills

• BS in Chemistry or Life Sciences preferred
• Extensive knowledge of IND/BLA/eCTD and other electronic requirements and guidelines
• Experience with DocuBridge software required, minimum of 2 years preferred
• A minimum of 3 years pharmaceutical and/or medical device industry experience
• A minimum of 3 years of regulatory affairs in FDA regulated products
• Expert skills in MS Office, Adobe Acrobat applications, electronic/document/data management systems
• Excellent editing and organizational skills
• Ability to handle multiple tasks with strong attention to detail
• Excellent interpersonal communication skills, both oral and written
• Ability to work under strict deadlines and shifting priorities

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Regulatory Publishing: 3 years (Required)
• FDA regulations: 3 years (Required)
• DocuBridge: 1 year (Required)

Work Location: Remote

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