Job Description

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 115,000 colleagues serve people in more than 160 countries.

Senior Specialist Regulatory Affairs

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, currently has an opportunity for a Senior Specialist Regulatory Affairs

Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions.

WHAT YOU’LL DO

• As the Senior Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, renewal, amendments, or periodic experience reports.
• Interacts with country affiliates to compile and prepare registration and submission documentation.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in some of the following: product plan development and implementation, and regulatory strategy
• Serves 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.
• Maintains annual food facility licenses.
• Maintains strong communication and working relationships across business functions, Third party manufacturers, and suppliers.

Required Qualifications

Required

• Bachelor’s Degree Preferred in science (biology, chemistry, microbiology, food science)
• Minimum 3 years’ experience in regulated industry (e.g. medicinal products, nutritionals)

MISC:

• This is an on-site role - not a remote role.
• Applicants from all geographic locations encouraged to apply for internal employees.
• There’s no relocation assistance available for this role.
• Certification is a plus (such as RD (Registered Dietician)
• 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

$78,000.00 – $156,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

AN Abbott Nutrition

LOCATION:

United States > Columbus : RP03

ADDITIONAL LOCATIONS:

United States > Abbott Park : AP06C

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf