Regulatory Affairs Specialist Nutrition Columbus, OH or Abbott Park, IL
Regulatory Affairs Specialist Nutrition Columbus, OH or Abbott Park, IL
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
JOB DESCRIPTION:
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. Youll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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 YOULL 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
- Bachelors 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.
- Theres no relocation assistance available for this role.
- Sponsorship: we will not provide sponsorship of any kind for this role (including OPT).
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
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 on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$60000.00 $120000.00In 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: EEO is the Law link - Espanol: Experience:
IC
Employment Type
Full-Time
Key Skills
Similar Jobs
Dr. Job is an online platform that connects employers with skilled job seekers, facilitating the search for job opportunities and top talent. Established in 2015. Dr. Job Pro has emerged as the world premier job portal, attracting thousands of job seekers every day from all over the world.
Follow Dr.Job
Dr Job FZ LLC. 2025 © All Rights Reserved