Regulatory Affairs Submissions Coordinator
3 dni temu
ManpowerGroup Sp. z o.o., a global leader in the staffing industry, is seeking a highly skilled Regulatory Affairs Submissions Specialist to join our team.
About the JobWe are recruiting for a Regulatory Affairs Professional Submission Specialist (Mid and Senior position) to support our client specialized in pharma industry.
Job DescriptionThe Experienced RA Submissions Professional collaborates with colleagues to ensure compliance with regulatory agency regulations and interpretation. This position coordinates and compiles medium to complex dossier plans/submission packages and may publish/dispatch.
Main Responsibilities- Creates and manages the Dossier Plan(s)/Submission Packages in line with regulatory strategy. Provides guidance to project team members.
- Ensures that all required documents are included in the Dossier/Submission Package.
- Performs a dossier review of the published output.
- Tracks submission events/activities and timelines in appropriate systems/tools.
- Leads submission team meetings, as applicable. Works with partners to resolve issues with time lines.
- Monitors the effectiveness of the dossier process to identify improvement opportunities.
- Leads and/or participates in special projects and process improvement initiatives, as needed.
- In-depth understanding of the product development process.
- Degree in pharmacy, bioscience or similar fields would be an asset.
- Experience in in regulatory, medical, or pharmaceutical fields, or a background in information/library science.
- Effective interpersonal, teamwork, and communication skills.
- Ability to work or lead in a matrix environment.
- Fluency in English.
- Proficient use of Regulatory Information Systems, planning, and publishing tools.
We offer:
- Opportunity to join a global team and work on global innovative projects.
- Option for 100% remote job within Poland.
- Work mainly in English within an international team.
- Attractive salary.
- ManpowerGroup Benefit Package: healthcare, sports card, possibility of joining group insurance, professional development program.
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