Senior Specialist Regulatory Affairs - Nutrition

1w1 week ago

Abbott

Columbus, US · Full-time · $78,000 – $156,000

About this role

Abbott's nutrition business develops science-based nutrition products for people of all ages, from babies to adults. Millions rely on brands like Similac, PediaSure, Pedialyte, Ensure, and Glucerna. The Senior Specialist Regulatory Affairs role offers comprehensive knowledge in directing complex regulatory projects.

This position involves executing highly complex or specialized projects in Regulatory Affairs, adapting precedents to develop innovative solutions. Serve as a highly experienced resource for product registration submissions, renewals, amendments, and periodic reports. Interact with country affiliates to prepare submission documentation.

Act as regulatory liaison throughout the product lifecycle and representative to marketing, research teams, and agencies. Manage product changes by assessing regulatory impact and international requirements. Maintain annual food facility licenses and strong relationships across functions, third-party manufacturers, and suppliers.

At Abbott, grow your career with an international company, access free medical coverage, excellent retirement savings, tuition reimbursement, and education benefits like FreeU. Recognized as a great place to work worldwide and one of Fortune's most admired companies.

Requirements

Bachelor’s degree preferred in science (biology, chemistry, microbiology, food science)
Minimum 3 years’ experience in regulated industry (e.g., medicinal products, nutritionals)
Comprehensive knowledge in Regulatory Affairs
Ability to execute highly complex or specialized projects
Adapt precedents and make significant departures from traditional approaches to develop solutions
Experience directing regulatory submissions and interacting with affiliates
Knowledge of product lifecycle regulatory requirements
Familiarity with assessing regulatory impact of product changes

Responsibilities

Direct development of product registration submissions, progress reports, renewals, amendments, or periodic experience reports
Interact with country affiliates to compile and prepare registration and submission documentation
Serve as regulatory liaison throughout product lifecycle
Participate in product plan development and implementation, and regulatory strategy
Serve 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
Maintain annual food facility licenses
Maintain strong communication and working relationships across business functions, third-party manufacturers, and suppliers

Benefits

Career development with an international company
Free medical coverage in Health Investment Plan (HIP) PPO medical plan
Excellent retirement savings plan with high employer contribution
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit
Recognized as a great place to work in dozens of countries and one of Fortune's most admired companies
Best place to work for diversity, working mothers, female executives, and scientists