Job Title: Junior Regulatory Specialist
Location: Irving, TX
Duration: 12 Month Assignment
Experience Required
- This position does not require previous regulatory experience. 2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.
- Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
- Work with cross-functional teams. Work with people from various disciplines and cultures.
- Write and edit technical documents.
- Negotiate internally.
- Pay strong attention to detail.
- Manage projects. Create project plans and timelines.
- Think analytically and critically.
- Organize and track complex information.
- Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Has a sound knowledge of a variety of alternatives and their impact on the business.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.