Abbott Regulatory Affairs Specialist in Irving, Texas

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.

Summary:

As an individual contributor, the function of a 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 exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.

Main Responsibilities:

  • 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.

  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.

  • Understand and investigate 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 riskbenefit analysis for regulatory compliance.

  • Monitor applications under regulatory review.

  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

  • Assist in preparation and review of regulatory submission to authorities.

  • Maintain annual licenses, registrations, listings and patent information.

  • Assist compliance with product postmarketing approval requirements.

  • Assist in the review of advertising and promotional items.

  • 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.

  • Contribute to the development and functioning of the crisis/ issue management program.

  • Ensure product safety issues and productassociated events are reported to regulatory agencies.

  • Provide regulatory input for product recalls and recall communications.

Accountability/Scope/Budget:

  • Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.

  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.

  • Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

  • May lead a departmental project team.

  • Participates in determining goals and objectives for projects.

  • Influences middle management on technical or business solutions.

  • May interact with vendors.

  • Plans and organizes non-routine tasks w/approval.

  • Initiates or maintains work schedule.

  • Establishes priorities of work assignments.

  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

  • Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.

  • Comments (Optional):

  • Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.

Qualifications:

Bachelors degree (or equivalent); Bachelors 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.) 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. Note: Higher education may compensate for years of experience. 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 crossfunctional 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 Apply business and regulatory ethical standards

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 corpjat@abbott.com