Job Information
Abbott Regulatory Affairs Specialist (One Year Contractor) in Zwolle, Netherlands
What are you responsible for?
Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF & FUF, Drug for EURI/ MENAP/ global. Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies and amendments.
Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changes.
Partnership with affiliates to support regulatory agency interactions to expedite approval of pending registration.
Participates/ Awareness on project plans, 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.
Support review of change controls to determine the level of change and consequent submission requirements.
Support pulling reports, metrics related to submissions and approvals.
Offers country specific regulatory support.
Direct interaction with RA functions including Regulatory Operations, Submissions Execution, Regulatory Project Management, Strategic Area and other stakeholders such as Project managers, Manufacturing Plants, affiliates, R&D, Technical center & Product Developers.
Who are you?
Prior experience (2-3yrs) and bachelor’s degree in nutrition/science related field.
Good understanding and working experience in different regulatory environment in multiple countries.
Experience in registration filing process of new nutrition products preferred.
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.
Adaptable in cultural and political diversity.
Capacity to learn and challenge status quo.
Team player
Self-motivated.
How do you apply?
Do you enjoy working in an international organization that contributes to healthcare and do you recognize yourself in this profile, then we would like to receive your response.
You can apply with your CV and motivation via our website
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com