Senior Regulatory Affairs Specialist - Pediatric Nutrition Brands; (Kid/Toddler) - 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 109,000 colleagues serve people in more than 160 countries.

Senior Regulatory Affairs Specialist

Nourish the world and your career as part of the Nutrition team at Abbott.

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®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their life to the fullest.

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

Position Summary

As an individual contributor, the function of a Senior 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.

WHAT YOU'LL DO
  • Interpret and apply regulatory requirements for the United States pediatric nutrition business
  • 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. May lead cross-functional project teams.
  • 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
  • Where applicable, determine and communicate notification requirements for product registration in the United States; prepare and submit notifications


EDUCATION AND EXPERIENCE, YOU'LL BRING

Required
  • MS or PHD in Human Nutrition, Dietetics, Biological Science, or related
  • Individual executes and manages technical and scientific regulatory activities. 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.


Qualifications, Skills, and Experience
  • Excellent communication (oral and written) required: communicate with diverse internal and external audiences and personnel using various forms of communication, collaborate with cross-functional teams, write and edit technical documents. Experience working with regulatory agencies and/or trade associations is a plus.
  • Cross-functional partner: serve as subject matter expert and regulatory lead on cross-functional teams including those for new product development, process improvement, and business maintenance
  • Must be able to follow scientific arguments. Experience with clinical studies and working in a clinical setting is preferred.
  • Demonstrated ability to work independently, pay strong attention to detail, think analytically, take initiative, and manage projects is necessary
  • Knowledge of United States regulations relating to foods / nutritional products preferred. Experience defining regulatory strategy is a plus.
  • Knowledge of principles and requirements of promotion, advertising and labeling preferred


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities


Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.

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