Regulatory Associate - Publishing & Submissions

Why This Role Matters
The Regulatory Associate plays a crucial role in ensuring that all regulatory submissions are prepared, formatted, and delivered accurately and on time. By managing publishing, dispatching, and archiving of submissions in compliance with agency standards, the Regulatory Associate supports the organization’s commitment to regulatory compliance and timely product approvals. This role ensures high-quality submissions, enabling smooth interactions with regulatory authorities and contributing to successful drug development and market access.

Job Description
The Regulatory Associate is responsible for publishing, formatting, and dispatching regulatory submissions in agency-recommended formats. The role involves collaborating with cross-functional teams, performing quality control checks, troubleshooting technical issues in document preparation, and ensuring timely delivery of submissions. The Regulatory Associate also maintains knowledge of agency standards, manages technical aspects of submissions, and ensures that documents meet client and internal requirements for regulatory compliance.

Key Features Of The Role
• Publish, dispatch, and archive regulatory submissions in agency-recommended formats
• Ensure timely delivery of high-quality submissions following internal processes and client requirements
• Prepare submission-ready documents for electronic submissions, including formatting, hyperlinking, and processing in MS Word and Adobe Acrobat
• Develop and maintain up-to-date knowledge of established agency standards and procedures for regulatory submissions
• Troubleshoot document issues with Adobe Acrobat and MS Word
• Manage technical aspects and status updates for assigned submissions
• Collaborate with various departments for planning, preparation, publishing, and quality control checks of submissions
• Maintain compliance with internal SOPs and regulatory guidelines
• Support improvements in document preparation processes and publishing workflows

Responsibilities
• Prepare and format regulatory documents for electronic submissions according to agency standards
• Perform quality checks on submission documents to ensure accuracy, completeness, and compliance
• Troubleshoot and resolve technical issues related to document formatting, hyperlinks, and PDFs
• Track submission status and provide updates to internal stakeholders
• Maintain submission archives and records for easy retrieval and audit readiness
• Collaborate with regulatory, clinical, and quality teams to ensure coordinated preparation of submissions
• Support the implementation of publishing tools, validation software, and new processes
• Keep up-to-date with changes in regulatory guidelines and publishing standards
• Assist in training junior staff on submission formatting, publishing, and quality control practices

Required Qualifications

Educational Requirements
• Bachelor’s Degree in Pharmacy or related field

Experience And Skills
• Prior experience in regulatory publishing and submissions
• Proficiency in MS Word and Adobe Acrobat for document preparation and formatting
• Familiarity with electronic submission requirements and validation tools
• Knowledge of agency standards and regulatory submission processes
• Strong attention to detail and commitment to accuracy
• Good communication skills and ability to collaborate with cross-functional teams
• Ability to troubleshoot technical issues in submission documents

Salary Insights
• Compensation as per company norms and industry standards
• Performance-based incentives and opportunities for career growth
• Exposure to regulatory submission processes and electronic publishing tools

Company Overview
The organization is a global clinical research and pharmaceutical services provider, committed to delivering high-quality regulatory, clinical, and drug development solutions. The company emphasizes professional growth, collaborative teamwork, and adherence to regulatory compliance standards to ensure successful project outcomes and timely submissions.

FAQs
Q: What type of submissions will I work on?
A: The Regulatory Associate will handle regulatory submissions in agency-recommended electronic formats, including formatted documents, PDFs, and hyperlinks.

Q: Will I need technical skills?
A: Yes, proficiency in MS Word, Adobe Acrobat, and familiarity with publishing and validation tools is required.

Q: Is prior experience in regulatory publishing mandatory?
A: Yes, prior experience in publishing and regulatory submissions is required.

Application Tips
• Highlight prior experience in regulatory publishing and electronic submissions
• Showcase proficiency in MS Word, Adobe Acrobat, and validation tools
• Demonstrate attention to detail and knowledge of agency submission standards
• Emphasize ability to collaborate with cross-functional teams and meet deadlines