Regulatory Affairs Submissions Specialist

Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!

For our client specialized in pharma industry, we are recruiting for a role of Regulatory Affairs Professional Submission Specialist (Mid and Senior position).

Mid Position: The 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.

Senior Position: The Sr. RA Submissions Professional is responsible for the submission operational management and delivery of regulatory submissions required to support the development, registration, and compliance of products. This position coordinates and compiles complex dossier plans/submission packages in accordance with regulations and relevant guidelines and may publish/dispatch. 

Main tasks:

• Creates and manages the Dossier Plan(s)/Submission Packages in line with regulatory strategy. Provides guidance to project team members. Seeks input from regulatory therapeutic areas, functional area representatives and key stakeholders
• 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. (e.g., with time lines, document e-sub readiness etc.)
• Monitors the effectiveness of the dossier process to identify improvement opportunities
• Leads and/or participates in special projects and process improvement initiatives, as needed
• May create and/or sign specific submission documents
• Where appropriate provides component-level publishing support for Regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.)
• Utilizes current electronic document management systems/tools and/or publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions, with a high degree of independence
• Applies appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements
• Cultivates ongoing effective relationships within GRA as well as cross-functionally. Works with partners to communicate and resolve issues/concerns with submission timelines

Requirements:

• 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
• Knows who stakeholders are and builds effective relationships
• In-depth knowledge of project and submission management
• Demonstrated problem-solving, troubleshooting, and adaptability
• Proficiency in submission related HA and Industry regulations and guidelines as relevant

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 

Permanent job offer.