Regulatory Affairs Associate

🔥 6 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🚫👨‍🎓 No degree required

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Bimeda

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1960

🏭 Manufacturing

🏥 Healthcare

🌾 Agriculture

Manufacturing • Healthcare • Agriculture

Bimeda is a global leader in animal health, specializing in the development and manufacturing of veterinary pharmaceuticals, vaccines, and health products for a wide range of animals including livestock, poultry, horses, companion animals, and aquatic species. Operating in over eighty countries, Bimeda is dedicated to optimizing animal health and wellbeing with a significant focus on research and development, supported by multiple manufacturing and R&D facilities worldwide. With a strong commitment to quality and sustainability, Bimeda employs over 1,000 staff and holds more than 1,600 marketing authorizations for its diverse product range.

📋 Description

• Manage regulatory maintenance activities for approved NADA and ANADA products • Maintain approved NADA and ANADA applications throughout the product lifecycle • Compile and submit annual reports, CMC submissions, labeling supplements, and correspondence with regulatory agencies • Maintain regulatory records, submission archives, commitments, and approval histories • Ensure compliance with applicable regulations, guidance documents, and approved filings • Monitor evolving FDA and industry requirements through review of regulations, guidance documents, and industry publications • Gather GMP documentation for post-approval submissions for US-marketed products through cross-functional communication • Coordinate communications and maintain state registrations for drug product distribution • Prepare electronic submissions to FDA-CVM • Perform regulatory reviews and assess cGMP documentation • Determine appropriate reporting categories under FDA regulations

🎯 Requirements

• Minimum of two (2) years of experience working in a professional office or laboratory environment managing documents, records, and multiple concurrent priorities • Proficiency in Microsoft 365 applications (Word, Excel, PowerPoint, Teams, and Outlook) • Ability to learn and effectively utilize digital regulatory, document management, and AI-enabled productivity tools • Experience using Adobe Acrobat Pro, Foxit PDF Editor, or similar document management software • Strong written and verbal communication skills • Excellent organizational skills with a high degree of accuracy and attention to detail • Ability to work independently, prioritize tasks, and manage multiple responsibilities effectively • Self-motivated with a collaborative, team-oriented approach • Eagerness to learn and develop new skills • Ability and willingness to travel occasionally (approximately 2%) • Minimum of two (2) years of experience in regulatory affairs, the pharmaceutical industry, or a similarly regulated environment • Experience 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 similar 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 • Associate's, Bachelor's, or equivalent post-secondary degree in a related field is desirable • Ability to build and maintain lasting 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