Abbott Senior Specialist Regulatory Affairs in Lake Forest, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
• Assist in SOP development and review
• Provide regulatory input to product lifecycle planning
• Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
• Understand; investigate and evaluate regulatory history/background of class; disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
• Determine trade issues to anticipate regulatory obstacles
• Determine and communicate submission and approval requirements
• Participate in risk-benefit analysis for regulatory compliance
• Assess the acceptability of quality; preclinical and clinical documentation for submission filing
• Compile; prepare; review and submit regulatory submission to authorities
• Monitor impact of changing regulations on submission strategies
• Monitor applications under regulatory review
• Monitor and submit applicable reports to regulatory authorities
• Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Maintain annual licenses; registrations; listings and patent information
• Assist compliance with product postmarketing approval requirements
• Review and approve advertising and promotional items to ensure regulatory compliance
• Assess external communications relative to regulations
• Review regulatory aspects of contracts
• Assist with label development and review for compliance before release
• Submit and review change controls to determine the level of change and consequent submission requirements
• Analyze the input of cumulative product changes to current product submissions
• Contribute to the development and functioning of the crisis/ issue management program
• Ensure product safety issues and product-associated events are reported to regulatory agencies
• Provide regulatory input for product recalls and recall communications
Position Accountability / Scope:
Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues; and must assure that deadlines are met. Effectively communicate; prepare; and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Work is reviewed upon completion for adequacy in meeting objectives. Individual is recognized as an expert in work group.
Bachelor's degree (or equivalent); Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Minimum Experience / Training Required:
2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals).
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com