Regulatory Affairs Project Manager - Nutrition - Columbus OH/Abbott Park, IL (internal OUS)

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 Project Manager

About Abbott

Our nutrition business develops science-based nutritional 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 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

This position works out of our Abbott Park, IL location in the Nutrition Division.

What You’ll Work On

Primary Function/Primary Goals/Objectives:  
1.    Combine knowledge of scientific, regulatory and business issues to enable Abbott Nutrition products to meet required legislation.  
2.    Have department/group/site level influence and be generally recognized as an expert resource within the department.  May also share knowledge and expertise with others in support of team activities.  
3.    Identify emerging regulatory issues and analyze broad scope implications of changing regulations and guidance. 
4.    Identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. 
5.    Utilize technical regulatory skills to propose strategies on complex issues.

Major Responsibilities:
1.    Responsible for compliance with applicable Corporate and Divisional Policies and procedures and evaluation of regulatory risks of these documents.
2.    Responsible for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs.
3.    Provide regulatory input to product and/or packaging lifecycle planning and in all stages of product and/or packaging development.
4.    Anticipate regulatory obstacles and emerging issues throughout the product and/or packaging lifecycle and work with appropriate teams to develop solutions.
5.    Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
6.    Interpret and apply regulatory requirements.
7.    Monitor and influence external environment for impact on company products/business activities (e.g., regulation changes, government practices, trade association activities, etc.).
8.    Recruit, develop and mentor regulatory professionals.
9.    Maintain regulatory data in electronic systems.
10.    Depending on specific role, the Regulatory Affairs Project Manager may be involved in various regulatory activities (market access activities, regulatory submissions/registrations; evaluation of product and/or packaging and manufacturing changes for regulatory implications; maintaining compliance documentation,; review and approval of label changes, advertising and promotional items; oversight of systems related to product and/or packaging management, project management, process improvement, etc.).    

Supervisory/Management Responsibilities (Influence/Impact/Leadership):       
1.    Provide leadership without direct authority (i.e., project leader) and provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments.  May mentor other department members.
2.    Develop, communicate, and build consensus for operating goals that are in alignment with the division.
3.    Provide leadership by communicating and providing guidance towards achieving department objectives.
4.    Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
5.    Perform work without appreciable direction.

Accountability/Scope:
1.    Execute and manage technical and scientific regulatory activities.   
2.    Function independently as a decision-maker on regulatory issues and assure that deadlines are met.      
3.    Effectively communicate, prepare, and negotiate internally and externally with key stakeholders, various regulatory agencies, trade associations, etc.
4.    Create immediate to long-range plans to carry out objectives established by top management.  

EDUCATION AND EXPERIENCE, YOU’LL BRING
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.  
• 5 years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area.
• 4-5 years of experience in a regulated industry (e.g., food, nutritionals, medical products).   

Note:  Higher education may compensate for years of experience or vice versa.

Preferred

• M.S. in a technical area.  A Ph.D. in a technical area or law is helpful.  Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Regulatory knowledge of food contact packaging requirements
• Regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc. (Outside the US)
• Principles and requirements of 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.
  • Follow scientific arguments, identify regulatory scientific data needs, solve regulatory issues, and define regulatory strategy.
• Evaluate various technical alternatives and perform risk assessment and analysis. 

Other skills:
a.    Strong attention to detail.
b.    Create and manage project plans and timelines.
c.    Manage multiple and competing priorities.
d.    Think analytically; creatively solve problems; organize and track complex information.
e.    Plan and conduct effective meetings.
f.    Proficient computer skills. 

MISC:

• This is an on-site role - not a remote role.
• Sponsorship: we will not provide sponsorship of any kind for this role (including OPT).
• Relocation assistance is not offered for this role.

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 > 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.pdf

     

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