Collabera
Regulatory Affairs Associate
Collabera, North Chicago, Illinois, us, 60086
Description
HomeSearch JobsJob Description
Regulatory Affairs Associate
Contract: North Chicago, Illinois, US
Salary: $30.00 Per Hour
Job Code: 351410
End Date: 2024-10-03Days Left: 9 days, 3 hours left
Apply
To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!
Job Description:Job Roles & Responsibilities: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, amendments, etc ...Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changesPartnership 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 requirementsSupport pulling reports, metrics related to submissions and approvals.Offers country specific regulatory supportSystem VEEVA experience is helpfulStakeholders:
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.Skills/Experience Requirements:
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 playerSelf-motivated.Job Requirement
Regulatory Affairs AssociateRegulatory AffairsRegulatory Affairs SpecialistRegulatory SubmissionPharmaceuticalFood ScienceProduct RegistrationdossiersNutrition ScienceBiotechnologyPharmaPharmaceuticalsReach Out to a RecruiterRecruiterEmailPhoneChitrank Rastogichitrank.rastogi@collabera.com4255231648
Apply Now
HomeSearch JobsJob Description
Regulatory Affairs Associate
Contract: North Chicago, Illinois, US
Salary: $30.00 Per Hour
Job Code: 351410
End Date: 2024-10-03Days Left: 9 days, 3 hours left
Apply
To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!
Job Description:Job Roles & Responsibilities: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, amendments, etc ...Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changesPartnership 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 requirementsSupport pulling reports, metrics related to submissions and approvals.Offers country specific regulatory supportSystem VEEVA experience is helpfulStakeholders:
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.Skills/Experience Requirements:
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 playerSelf-motivated.Job Requirement
Regulatory Affairs AssociateRegulatory AffairsRegulatory Affairs SpecialistRegulatory SubmissionPharmaceuticalFood ScienceProduct RegistrationdossiersNutrition ScienceBiotechnologyPharmaPharmaceuticalsReach Out to a RecruiterRecruiterEmailPhoneChitrank Rastogichitrank.rastogi@collabera.com4255231648
Apply Now