Senior Specialist Regulatory Affairs

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.

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 healthiest life.

Our location in Abbott Park, IL currently has an opportunity for a Senior Specialist Regulatory Affairs. Open to this person being based out of our Columbus, Ohio office, or other international Abbott Nutrition locations.

WHAT YOU'LL DO

Responsibilities:
  • Regulatory project management for global programs (PIERs, Global Science Innovation, Supply Network, Strategic) without close supervision by manager
  • Lead strategic programs with supervision by manager
  • Develop and execute regulatory strategies to ensure successful registration and approval of international nutrition products
  • Represent Abbott Nutrition regulatory affairs on departmental and divisional teams, providing timely regulatory input and communication to ensure regulatory requirements are met
  • Analyze and identify regulatory requirements against project needs
  • Communicate registration needs before and during product development
  • Prepare options, suggestions, and/or a regulatory assessment for product registration to achieve global project goals
  • Execute plans, complete tasks according to priorities set by Manager, align work with business goals, and align actions with agreed upon strategies
  • Excellent verbal and written communication skills and ability to effectively present scientific data to management
  • Assure established policies and standard interpretations of regulations are followed for assigned projects. Maintain an awareness of legislation and assess impact on Abbott business.
  • Responsible for tracking and timely completion of regulatory assignments, registration assessments, and execution of filing
  • Responsible for effective communication of regulatory requirements to project teams and internal customers (scientists, marketing, quality assurance, product development, affiliates)
  • Accountable for compliance with internal SOPs and understanding & compliance with relevant regulations
  • Position is highly visible to internal and external stakeholders
  • Provide direction and oversight for position responsibilities


EDUCATION AND EXPERIENCE, YOU'LL BRING

Required:
  • Bachelor's degree is required (engineering, nutrition, chemistry or biological science is preferred)
  • 3 or more years of relevant experience (exposure to regulatory affairs is preferred)
  • Project management experience and/or exposure to project management principles
  • High level of effective verbal and written communication skills, including ability to negotiate, influence, and manage conflict
  • Able to work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates, etc.) to solve problems and communicate regulatory needs


Preferred
  • Master's degree
  • Prior regulatory experience in the food industry
  • Knowledge of regulations relating to foods, infant formula manufacturing and/or consumer products
  • Manufacturing/Quality/Packaging or similar experience


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • A fast-paced work environment where your safety is our priority
  • Production areas that are clean, well-lit and temperature-controlled
  • 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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