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Sr. Regulatory Affairs Specialist
| Company | Abbott Laboratories |
| Address | , Abbott Park, Il |
| Employment type | FULL_TIME |
| Salary | |
| Expires | 2023-07-26 |
| Posted at | 11 months ago |
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, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Primary Job Function
As an individual contributor; the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed; obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
Core Job Responsibilities
Responsible for implementing and maintaining the effectiveness of the quality system.
Core job responsibilities for this function may include:
- Review regulatory aspects of contracts
- Participate in risk-benefit analysis for regulatory compliance
- Monitor applications under regulatory review
- Maintain annual licenses; registrations; listings and patent information
- Assess the acceptability of quality; preclinical and clinical documentation for submission filing
- Compile; prepare; review and submit regulatory submission to authorities
- Monitor and submit applicable reports to regulatory authorities
- Assist compliance with product post marketing approval requirements
- Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
- Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
- Ensure product safety issues and product-associated events are reported to regulatory agencies
- Assess external communications relative to regulations
- Provide regulatory input to product life-cycle planning
- Submit and review change controls to determine the level of change and consequent submission requirements
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
- Determine and communicate submission and approval requirements
- Monitor impact of changing regulations on submission strategies
- Review and approve advertising and promotional items to ensure regulatory compliance
- Understand; investigate and evaluate regulatory history/background of class; disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
- Contribute to the development and functioning of the crisis/ issue management program
- Assist with label development and review for compliance before release
- Determine trade issues to anticipate regulatory obstacles
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
- Analyze the input of cumulative product changes to current product submissions
- Provide regulatory input for product recalls and recall communications
- Assist in SOP development and review
Supervisory/Management Responsibilities
Individual may provide direction and guidance to exempt and/or skilled non-exempt levels of employees. Also may be asked to evaluate performance of and assist in career development planning.
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.
Minimum Education
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
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