Regulatory Affairs Associate

This is a fully remote position, open to applicants in Texas.

📋 Description

• Oversee regulatory maintenance tasks for approved NADA and ANADA products.

• Sustain approved NADA and ANADA applications throughout their lifecycle.

• Compile and submit annual reports, CMC submissions, labeling supplements, and correspondence with regulatory bodies.

• Keep regulatory records, submission archives, commitments, and approval histories up to date.

• Ensure adherence to relevant regulations, guidance documents, and approved filings.

• Monitor changing FDA and industry standards by reviewing regulations, guidance documents, and industry publications.

• Collect GMP documentation for post-approval submissions for US-marketed products through cross-functional collaboration.

• Coordinate communications and maintain state registrations for drug product distribution.

• Prepare electronic submissions to FDA-CVM.

• Conduct regulatory reviews and evaluate cGMP documentation.

• Identify appropriate reporting categories in compliance with FDA regulations.

⛳️ Requirements

• At least two (2) years of experience in a professional office or laboratory setting managing documents, records, and multiple concurrent priorities.

• Proficient in Microsoft 365 applications (Word, Excel, PowerPoint, Teams, and Outlook).

• Capacity to learn and effectively use digital regulatory, document management, and AI-enabled productivity tools.

• Experience with Adobe Acrobat Pro, Foxit PDF Editor, or other similar document management software.

• Strong written and verbal communication abilities.

• Exceptional organizational skills with a high level of accuracy and attention to detail.

• Capability to work independently, prioritize tasks, and manage multiple responsibilities efficiently.

• Self-driven with a collaborative, team-oriented mindset.

• Willingness to learn and acquire new skills.

• Ability and readiness to travel occasionally (approximately 2%).

• A minimum of two (2) years of experience in regulatory affairs, the pharmaceutical industry, or a similarly regulated environment.

• Familiarity with FDA electronic submission systems, including eSubmitter and FDA ESG NextGen.

• Experience with SharePoint, electronic document management systems (EDMS), information management platforms, and project management software.

• Experience or demonstrated skills in project coordination, problem-solving, regulatory submissions, or exposure to manufacturing environments.

• Understanding of AI tools such as Microsoft Copilot, ChatGPT, or comparable platforms.

• Experience supporting document preparation, submission activities, or regulatory records management within a regulated industry.

• Knowledge of continuous improvement principles, regulatory monitoring activities, and regulatory risk identification.

• An Associate's, Bachelor's, or equivalent post-secondary degree in a relevant field is preferred.

• Ability to establish and maintain enduring relationships with cross-functional team members.

🏝️ Benefits

• Health Insurance (medical, dental, vision).

• 401(k) plan for retirement savings.

• Paid time off (vacation, sick leave, holidays).

• Life insurance.

• Employee assistance program.