Senior Regulatory Affairs Specialist

1 month ago

Green Oaks, United States Abbott Full time

The Opportunity

This position works out of our Lake Bluff, IL (Abbott Park) location in the Transfusion Medicine Division . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the New Product Development 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.

What You’ll Work On

Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Supports necessary regulatory activities required for product market entry and on-market support of transfusion systems, including instrument hardware, software and mainly assay support. Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review, and submit regulatory submission to authorities. Work with cross functional teams to review and approve protocols to ensure alignment with regulatory requirements. Strategic Planning: 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 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. Compile; prepare; review and submit regulatory submission to authorities (US and International). 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. Postmarket: 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 Job specific responsibilities may include (choose applicable areas and expand as appropriate). Participates as a Team Member: Actively contributes to the team process, commits to team goals, expresses opinions, and shares ideas freely. Contributes to the creation of the team's mission objectives and strategies, accepts team decisions, and works toward their implementation.

Required Qualifications

Bachelors degree in regulatory affairs preferred and may be used in lieu of direct regulatory experience, or an equivalent combination of education and work experience. Minimum 3 years experience.

Preferred Qualifications

Masters degree 3-4 years’ experience in a regulated industry (e.g., medical products, nutritional). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Knowledge of: Regulatory history, guidelines, policies, standards, practices, requirements, and precedents. Regulatory agency structure and processes. Principles and requirements of applicable regulations and agency guidance. Submission/registration types and requirements. GxPs (GCPs, GLPs, GMPs). Principles and requirements of promotion, advertising, and labeling. Ethical guidelines of the regulatory profession. Has broad knowledge of various technical alternatives and their potential impact on the business. Exercise good and ethical judgment within policy and regulations. Use in-depth knowledge of business functions and cross group dependencies/ relationships. Define regulatory strategy with supervision. Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.

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