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.

     

JOB DESCRIPTION:

Manager Regulatory Affairs

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.

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.

WORKING AT ABBOTT:

At Abbott, you can have a good job that can grow into a great career. We offer:

• 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, Medical Benefits start Day 1
• Vacation – 3 weeks accrued vacation (1st year is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• 401(k) retirement savings with a generous company match of 5%
• 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 stability of a company with a record of strong financial performance and history of being actively involved in local communities

Our location in Columbus, OH currently has an opportunity for a Manager, Regulatory Affairs supporting the US pediatric business.

Position Summary

As an individual contributor, the function of a Regulatory Affairs Manager 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, including those relevant to infant formula.
• 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.
• Author infant formula notifications for submission to US FDA
• 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 for external and internal consideration based on assessment.
• Where applicable, determine and communicate dossier requirements for novel ingredients.

EDUCATION AND EXPERIENCE, YOU’LL BRING: 

Required 

• MS or PhD degree in Human Nutrition, Dietetics, Biological Science, or related
• 5+ years executing and managing technical and scientific regulatory activities, 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 writing skills, specifically the competency to communicate scientific and/or technical information to internal and external audiences through clear, concise, and thorough writing.
• Ability to follow and develop scientific arguments.
• Experience serving as subject matter expert and/or regulatory lead on cross-functional teams such as those for new product development, process improvement, and business maintenance.
• Willingness to work both independently and in partnership with others.
• Proficiency using various forms of communication (email, PowerPoint slides, virtual meetings, in-person meetings, presentations, etc.) and information sharing/management systems.

• Self-driven to take initiative.

• High level of attention to detail.
• Analytical thinking skills.
• Ability to manage projects.

Preferred

• Experience with clinical studies and/or working in a clinical setting.
• Knowledge of United States regulations relating to foods/nutritional products
• Experience working with regulatory agencies and/or trade associations.
• Experience defining regulatory strategy.
• Knowledge of principles and requirements of promotion, advertising, and labeling

MISC:

• This is an onsite role (not a remote role)

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

$95,000.00 – $190,000.00

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:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 20 % 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.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf