Senior Regulatory Affairs Specialist, this position provide support to Nutrition business, the location will consider countries in Latin America (Guatemala, Peru, Colombia, Mexico) and United States (Abbott Park and Columbus).
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.
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 will have access to:
Career development with an international company where you can grow the career you dream of.
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 Opportunity
This position works out of our LATAM and US (open to Latin America and United States) location in the Nutrition business. 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.
As the Senior Regulatory Affairs Specialist, individual contributor, you will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide. Responsible for implementing and maintaining the effectiveness of the quality system. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
What you'll do:
Accountability / Scope:
It is a critical business continuity role, and the individual will work with Project teams to ensure timely submissions, approvals which enables business for timely launches.
As the professional in the Regulatory Affairs function, the individual will assist in the registration of products by preparing and submitting documentation needed for registration in Latin America.
Individual will execute and manage technical and scientific regulatory activities, understand regulations that might impact Regulatory submissions/ launches.
Individual shall develop strategic partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions and any deficiencies and develop approach to solutions.
Major Responsibilities:
Ensures timely approval of General Foods, Infant Milk, Drugs, Functional Health Foods for Latin America. Possess well developed skills in directing development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc …
Track regional submissions and maintain monthly metrics related to regional registrations, deficiencies and Right First Time Submissions.
Lead regional regulatory submissions strategy and update strategy based upon regulatory changes.
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
Partners with affiliates to support regulatory agency interactions to expedite approval of pending registration.
Serves as regulatory liaison throughout product lifecycle.
Participates/ Awareness on Affiliates Business plans, project plan, regulatory submission strategy, any risks management.
Advises project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Partner with other regulatory functions for smooth project transition and launch.
Partner with relevant stakeholders to determine trade issues to anticipate regulatory obstacles.
Submit and review change controls to determine the level of change and consequent submission requirements.
Offers country specific regulatory support.
Assist in SOP development and review.
Stakeholders:
Direct interaction with RA functions including Regulatory Project Management, Strategic Area and other stakeholders such as Project Managers, Manufacturing Plants, Affiliates, R&D, Technical center & Product Developers.
Requirements
Minimum requirements include:
Bachelor's degree in nutrition, Science related field.
5-7 years of experience.
Good understanding and working experience in different regulatory environment in multiple countries.
Fluency in Spanish and English (Advanced).
Digital skills: Microsoft Office.
Proven track record of successful registration filing process of new products.
Knowledge and understanding of formulation & scientific aspects of nutritional products.
Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Influence stakeholders on technical solutions.
Participates in determining goals and objectives for projects. Establishes and cultivates an extensive network of support to facilitate timely launches.
Adaptable in cultural and political diversity.
Capacity to learn and challenge status quo.
Team player
Self-motivated.
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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.