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.
JOB DESCRIPTION:
Regulatory Affairs Manager
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 Lake County/Abbott Park, IL, currently has an opportunity for a Regulatory Affairs Manager.
WHAT YOU’LL DO
- The Latin America Manager of the Regulatory Affairs Innovation oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports for pediatric nutritional products distributed in Latin America.
- Interacts with Affiliate Regulatory, Division Regulatory, international manufacturing plants, and other Divisional functional areas.
- Serves as regulatory liaison throughout product lifecycle.
- Participates in some of the following: Innovation product plan development and implementation, regulatory submission strategy, risk management.
- Serves as regulatory representative to marketing, manufacturing sites, project/program managers, research teams and regulatory agencies.
- Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Accountability/Scope
- The compliance of AN products is a competitive advantage in the marketplace, and any lessening of our standards or not meeting market requirements can have an adverse long-term impact on our business. This position will work with limited supervision.
Required Qualifications
Required
- Bachelor’s degree in a relevant discipline/or equivalent work experience is required (Chemistry, Microbiology, Food Science, Engineering, Business Administration).
- 5-7 years in a regulated nutritional food-manufacturing environment, preferably pediatric or medical nutrition products, in a Regulatory, Quality, R&D, Project Management, Procurement or Operations function and good knowledge of food and nutrition regulations.
- 3-5 years’ experience in project roles.
- Critical thinking/problem-solving skills.
- Ability to plan and facilitate meetings.
- Effective Stakeholder Management.
Preferred
- Master’s degree
- Spanish speaking or understanding of the language
- Ingredient expertise, process expertise, and formulation expertise in nutritional and infant concepts.
- Well-developed interpersonal, communication and negotiation skills.
- Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.).
- Change management.
- Sound decision-making skills contributing to high levels of competence, confidence and credibility are required.
- Cross-functional/cross-divisional experiences.
- Experience dealing with international locations.
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
$99,300.00 – $198,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
AN Abbott Nutrition
LOCATION:
United States > Abbott Park : AP06D
ADDITIONAL LOCATIONS:
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
