Senior Specialist Regulatory Affairs - Nutrition - Columbus, OH or Abbott Park, IL

Abbott • Columbus, OH

2d • Onsite

About The Position

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. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. This role is for a Senior Specialist in the Regulatory Affairs Sub-Function, considered as a highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, renewal, amendments, or periodic experience reports. It involves interacting with country affiliates to compile and prepare registration and submission documentation, and serving as a regulatory liaison throughout the product lifecycle. The role also participates in product plan development and implementation, and regulatory strategy, and serves as a regulatory representative to marketing, research teams and regulatory agencies. Additionally, the Senior Specialist will manage and evaluate product changes by assessing change scope, regulatory impact and international submission requirements, and maintain annual food facility licenses. Strong communication and working relationships across business functions, Third party manufacturers, and suppliers are essential.

Requirements

• Required Bachelor’s Degree in science (biology, chemistry, microbiology, food science)
• Minimum 3 years’ experience in regulated industry (e.g. medicinal products, nutritionals)

Nice To Haves

• Certification is a plus (such as RD (Registered Dietician))

Responsibilities

• Directing development of product registration submission, progress reports, renewal, amendments, or periodic experience reports.
• Interacts with country affiliates to compile and prepare registration and submission documentation.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in product plan development and implementation, and regulatory strategy.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Manage and evaluate product changes by assessing change scope, regulatory impact and international submission requirements.
• Maintains annual food facility licenses.
• Maintains strong communication and working relationships across business functions, Third party manufacturers, and suppliers.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement
• the Freedom 2 Save student debt program
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees