Regulatory Publisher

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• Manage the end-to-end publishing (preparation through delivery) of regulatory submissions (e.g., INDs, NDAs, BLAs) in electronic and paper formats according to US FDA requirements.
• Ensures compliance in document formatting, PDF specifications and eCTD formatting of submission components.
• Ensure compliance with document management systems and version control procedures for regulatory submissions.
• Coordinate with internal and client project team as needed for publishing and submission‑related issues and activities.
• Compiling, reviewing, processing, and approving submission documents for format compliance including, but not limited to: amendments/supplements, annual reports, study protocols, briefing packages, and CMC updates.
• Providing advanced MS Word and template training/guidance and troubleshooting support to authors and subject matter experts.
• Creating or reviewing publishing standards and style guides.

• Bachelor's degree and at least 5 years experience in a relevant field such as Life Sciences, Computer Science, or a related discipline.
• Prior experience leading regulatory submissions projects.
• Strong understanding of US regulatory requirements and guidelines (FDA, ICH).
• Proficiency in electronic submissions tools and software (e.g., eCTD, submissions software).
• Excellent project management skills with the ability to prioritize tasks and meet deadlines.
• Effective communication and interpersonal skills, with the ability to collaborate across functions and influence outcomes.
• Detail‑oriented with a focus on quality and accuracy of deliverables.
• Expert level Microsoft Word knowledge and experience, especially as is pertains to pre‑publishing submission components.

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.