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.
FAQs
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