Regulatory Affairs Specialist - Nutrition - Columbus, OH

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 114,000 colleagues serve people in more than 160 countries.

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:

• 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
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• 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.
• 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.

The Opportunity

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 get the nutrients they need to live their healthiest life.

Our location in Columbus, OH currently has an opportunity for a Regulatory Affairs Specialist .

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 will execute tasks and play a consultative role by partnering with cross business functions. The individual is responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs.

Responsibilities

• Interpret and apply regulatory requirements for the United States adult nutrition business including products used for tube feeding.
• Understand the business environment, the regulatory environment, and pertinent regulations. Use knowledge to conduct regulatory assessments, formulate regulatory strategy, advise teams, and implement organizational plans to ensure compliance and successful marketing of nutritional products.
• Participate as a team member in product innovation to build product pipeline. Provide technical leadership to business units, commit to team goals, and effectively communicate regulatory position.
• Communicate project status, regulatory requirements, regulatory timelines, and other pertinent information to the regulatory affairs teams, core functional teams, and other cross-functional colleagues.
• Assess product claims for regulatory compliance and assist in identifying data needed to support claims.
• Review and approve product labels, advertising, and promotional items for regulatory compliance.
• Review technical documentation for regulatory compliance.
• Review external communications for regulatory compliance.
• Assess emerging regulations for business impact and make recommendations based on assessment.
• Act as a subject matter expert for IT systems used by the local regulatory affairs team

Education and Experience

Required

• BS or MS in Human Nutrition, Dietetics, Biological Science, or related
• Must function independently as a decision-maker on regulatory issues, be able to organize and track complex information, collaborate and communicate with others, and assure that deadlines are met.
• Excellent communication skills (oral and written), specifically the competency to communicate scientific and/or technical information to internal and external audiences in a clear and concise manner.
• Ability to establish and maintain productive relationships with internal stakeholders (e.g., legal, quality assurance, manufacturing, nutrition science, medical affairs, marketing, product development)
• Ability to work independently, pay strong attention to detail, think analytically, take initiative, and manage projects is necessary

Preferred

• Knowledge of United States regulations relating to foods preferred. Experience defining regulatory strategy is a plus.
• Knowledge of principles and requirements of labeling and advertising
• Ability to follow scientific arguments. Experience with clinical studies and working in a clinical setting is preferred.
• Experience with the DevEx product lifecycle management software and/or Veeva claims management system

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $57,300.00 - $114,700.00. In specific locations, the pay range may vary from the range posted.