Regulatory Affairs Specialist

We're seeking a detail-oriented and proactive Senior Regulatory Associate to support the preparation and submission of high-quality regulatory documentation. This is a fantastic opportunity for professionals with 1-3 years of experience in Regulatory Affairs who are ready to take the next step in their career.

Key Responsibilities:

• Publish, dispatch, and archive regulatory submissions in agency-recommended formats.
• Ensure timely delivery of compliant, high-quality submissions aligned with client and internal standards.
• Format, hyperlink, and process submission-ready documents using MS Word and Adobe Acrobat.
• Troubleshoot technical issues related to document formatting and publishing tools.
• Collaborate cross-functionally to plan, prepare, and perform quality control checks on submissions.
• Support regulatory audits and compliance activities.
• Maintain up-to-date knowledge of agency standards and submission procedures.
• Manage technical aspects and provide status updates for assigned submissions.
• Use publishing and validation tools effectively.
• Mentor junior staff and contribute to SOPs, work instructions, and training materials.

What We're Looking For:

• Experience: 1-3 years in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of electronic submission standards and tools.
• Proficiency in MS Word, Adobe Acrobat, and publishing/validation platforms.
• Excellent communication and collaboration skills.
• Ability to work independently and manage multiple priorities.