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Manager Regulatory Affairs (Latin America) – Nutrition
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 113,000 colleagues serve people in more than 160 countries.
MANAGER REGULATORY AFFAIRS (LATIN AMERICA)
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®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.
WORKING AT ABBOTT
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- 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 yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays
- Company Paid Pension Plan
- 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
This position works out of our ABBOTT PARK, IL location in the NUTRITION DIVISION.
Responsible for compliance with applicable laws & regulations and with Corporate Divisional Policies and procedures. As part of the LATAM AN Regulatory group support the development and execution of Regulatory assessments to ensure successful registration and approval of nutritional products in Latin America countries by:
- Analyzing and identifying regulatory requirements against project needs
- Communicating registration needs prior to and during product development
- Identifying and obtaining documents needed and ensuring that they are effectively presented for the registration of the products.
- Preparing options, suggestions, and/or a regulatory assessment for product
Responsible for leading the LATAM Regulatory Labeling support team. Another core responsibility of this role may include representing LA Regulatory on teams tasked with creating and reviewing global product claims for LATAM region. This requires close collaboration with other functional areas including commercial, R&D, and medical.
WHAT YOU’LL WORK ON
- Provide regulatory input to product lifecycle planning
- Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
- Assist in the development of regional regulatory strategies and update strategies based upon regulatory changes.
- Determine and communicate submission and approval requirements
- Participate in risk evaluation analysis for regulatory compliance
- Monitor impact of changing regulations on submission strategies
- Monitor applications under regulatory review
- Review and approve Reginal advertising and promotional items to ensure regulatory compliance
- Assist with label review for compliance
- Submit and review change controls to determine the level of change and consequent submission requirements
- Provide regulatory input for product action and related communications
- BA/BS + 10 years, MS + 7 years, or PhD in Analytical Chemistry, Food Science, or equivalent with a background in method development and validation.
- 15+ years of deep expertise in analytical chemistry research, food & physical chemistry, method development, and troubleshooting with food and beverage products.
- Minimum 3 years of prior team leadership and talent development experience along with budgetary responsibility.
- Team oriented, with high energy and desire to achieve results. Ability to work in multidisciplinary teams and meet business goals.
- Excellent written and verbal communication skills to communicate with technical and commercial stakeholders the full relevance of scientific observations and to produce documents and reports. Strong organizational skills required.
- Strong understanding of GLP, ISO 17025, and other laboratory quality requirements.
- Proficient with basic computer skills, including word processing, spreadsheets, presentations, and lab information systems.
- Minimum Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nutrition, food science, etc.) or medical fields is preferred plus 5 years of experience in a regulated industry (e.g., medical products, nutritionals).
- 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- Note: Higher education may compensate for years of experience.
- Fluency in Spanish and English.
- 10% travel
* 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.
Job posted: 2022-07-10