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

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.

 Regulatory Affairs Specialist     

Working 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®, 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. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• 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, 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

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

WHAT YOU’LL DO

Primary Function/Primary Goals/Objectives:  

• Provide support for the regulatory department to ensure efficient and compliant business processes and environment.  
• Execute regulatory tasks and exercise influence generally at the middle management level.
• Maintain current registrations by preparing documentation required and submitting documentation on schedule as directed.

Major Responsibilities:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs.

•  Support maintenance of Regulatory Affairs quality system documentation
• Provide regulatory input to product lifecycle planning.
• Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
• Interpret and apply regulatory requirements.
• Understand the business environment and relate extensive knowledge of internal and external activities to trends; Determine trade issues to anticipate regulatory obstacles.
• Participate in risk-benefit analysis for regulatory compliance.
• Plan and organize project assignments of substantial variety and complexity; initiate and/or maintain schedule for projects and project milestones.
• Maintain regulatory data in electronic systems.
• Depending on specific role, the Regulatory Affairs Specialist may be involved in various regulatory activities (review of documentation; regulatory submissions and follow-up; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses, registrations, listings with regulatory IT systems management and data analytics.

Influence/Impact/Leadership:

• May provide direction and guidance to exempt and/or skilled non-exempt levels of employees;
• Participate in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
• Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
• Perform work under minimal supervision and may independently determine and develop approach to solutions.

Required Qualifications

Required

• Bachelor's degree (or equivalent) is required - preferred area of focus in science (biology, chemistry, nutrition, dietetics, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields.  

Preferred

•  2-3 years of experience in a regulated industry (e.g., nutritionals, medical products).  Regulatory area is preferred, but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Note:  Higher education may compensate for years of experience or vice versa.

• This position does not require previous regulatory experience. 
• Regulatory knowledge of (as applicable - note: This knowledge may be developed through tenure in this position.):

  Regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc.

  Principles and requirements of regulatory submissions, advertising/promotion,  and labeling.

• Communication skills and ability to:

Communicate effectively verbally and in writing  Communicate with diverse audiences and personnel. Work with and negotiate with people from various disciplines, organizations, and cultures. Solve regulatory issues and define regulatory strategy Evaluate various technical alternatives. 

• Other skills:
  Strong attention to detail.
  Create and manage project plans and timelines.
  Think analytically; organize and track complex information.
  Proficient computer skills. 
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.

Accountability/Scope:

• Execute and manage regulatory activities.
• Ability to work independently and prioritize work to meet deadlines
• Resourceful, ability to use resources to solve problems
• May lead a departmental project team.

MISC:

• This is an on-site role - not a remote role.
• There’s no relocation assistance available for this role.
• Sponsorship: we will not provide sponsorship of any kind for this role (including OPT).

Apply Now

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 $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.