Senior Associate Regulatory Affairs -Publishing Job at Meitheal Pharmaceuticals,

Senior Associate Regulatory Affairs - Publishing

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Position Summary

The Regulatory Affairs Senior Associate is responsible for providing effective support to the Publishing Operations function in Regulatory Affairs. The responsibilities for this position include utilizing publishing systems and processes for the preparation of high-quality submission dossiers, ensuring compliance with the FDA regulations and internal policies/procedures. Pharmaceutical experience required.

Essential Duties and Responsibilities

• Prepare, compile, publish, validate, and submit electronic regulatory submissions (eCTD) for ANDA, NDA, BLA, IND, and DMF applications.
• Manage pre‑approval, post‑approval, and lifecycle management submissions, including Annual Reports, PADERs, PAS, CBE‑0, CBE‑30, Amendments, Supplements, and Safety Reports.
• Publish and submit Promotional and Advertising materials in compliance with FDA OPDP/2253 requirements.
• Perform advanced quality control (QC) reviews of submission components, including XML backbone, metadata, hyperlinks, bookmarks, file naming conventions, and validation reports.
• Submit eCTD submissions through the ESG FDA gateway, ensuring all components meet eCTD format requirements in collaboration with the publishing operations lead.
• Handle ANDA, NDA, and BLA submissions for pre‑approval, post‑approval, and promotional materials, supporting full product lifecycle management.
• Develop and maintain an in‑depth understanding of relevant US and EU regulatory requirements for submissions.
• Troubleshoot and resolve complex technical issues related to publishing systems, validation errors, gateway rejections, large file handling, and system performance.
• Perform administrative tasks related to submissions, including transferring files via FTP servers.
• Input submission information into internal databases and systems per company procedures.
• Perform other duties as assigned to support Regulatory Affairs publishing operations.

Competencies

• Planning and Organizing
• Teamwork
• Problem Solving
• Quality
• Judgement
• Dependability

Qualifications

• Assimilate to changing environments.
• Ability to prioritize and multitask.
• Organized and detailed orientated.
• Have a sense of urgency to meet all required deadlines.

Education and/or Experience Required

Bachelor's degree from a 4‑year college or university; over 3‑4 years pharma experience and/or training; or equivalent combination of education and experience.

Computer Skills

Excellent dexterity: Microsoft Office (Word, Excel, Power Point and Outlook), Adobe Systems (Pro, Acrobat DC), and Practice Database system (DocuBridge, Veeva Systems, eCTD Manager, Liquent Insight publisher, etc).

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Salary Description

$70,000 to $85,000