Opis stanowiska podany przez pracodawcę:

Job Tasks:

• Navigate through systems and tools to assemble, publish, validate, dispatch, and archive complex regulatory submissions in both paper and electronic formats, adhering to internal processes and regulatory guidelines, with a high level of independence
• Provide component-level publishing support for regulatory deliverables in PDF format, ensuring compliance with submission standards (e.g., bookmarking, linking, PDF versioning)
• Apply regulatory submission standards, requirements, processes, and policies to ensure adherence to internal and external health agency guidelines
• Maintain timely and effective communication with publishing contributors and responsible regulatory affairs professionals
• Provide technical guidance to submission contributors on submission requirements, standards, and processes to facilitate efficient processing by regulatory agencies
• Manage multiple complex submissions simultaneously, working with a high degree of independence
• Interpret and enforce paper and electronic submission standards, policies, and operating procedures
• Collaborate closely with various departments within Regulatory Affairs to ensure smooth processes

Requirements:

• Proficiency in using Regulatory Information Systems, planning, and/or publishing tools
• In-depth knowledge and experience with various submission and application types, publishing templates, and relevant regulatory agency and industry guidelines
• Strong project or submission management skills
• Deep understanding of therapeutic areas and the product development process
• Fluency in English
• Ability to work or lead in a matrix environment
• Strong interpersonal, teamwork, networking, and communication skills
• Ability to influence and develop work practices, standards, and procedures across the organization
• Capability to coach and mentor colleagues on applicable guidelines, standards, and publishing requirements

Offer:

• Opportunity to join a global team and contribute to innovative projects in international markets
• Option for 100% remote work within Poland
• Work primarily in English within a dynamic, international team
• Competitive salary
• Benefits package including healthcare, sports card, and insurance

The offer applies to permanent work.

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