Sr. Regulatory Affairs Specialist

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.

Regulatory Affairs Specialist

Des Plaines, IL

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
• Career development with an international company where you can grow the career you dream of .
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• An excellent retirement savings plan with high employer contribution

The Opportunity

As an individual contributor, the function of a Sr. 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.

MAIN RESPONSIBILITIES

Regulatory Knowledge

• Submission/registration types and requirements
• Interpret and apply regulatory requirements
• Domestic and international regulatory guidelines, policies and regulations
• Regulatory agency structure, processes and key personnel
• Ethical guidelines of the regulatory profession, clinical research and regulatory process
• Principles and requirements of applicable product laws
• Principles and requirements of promotion, advertising and labeling
• Compile, prepare, review and submit regulatory submissions to authorities
• Regulatory history, guidelines, policies, standards, practices, requirements and precedents

Communication

• Work with cross-functional teams
• Communicate effectively verbally and in writing
• Work with people from various disciplines and cultures
• Write and edit technical documents
• Negotiate internally and externally with regulatory agencies
• Communicate with diverse audiences and personnel
• Clearly explain and articulate Regulatory plans to peer groups

Cognitive Skills

• Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues
• Define regulatory strategy with supervision
• Has broad knowledge of various technical alternatives and their potential impact on the business
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Exercise good and ethical judgment within policy and regulations
• Organize and track complex information
• Use in-depth knowledge of business functions and cross group dependencies/ relationships
• Think analytically and critically

The base pay for this position is $71,300.00 – $142,700.00. In specific locations, the pay range may vary from the range posted.