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Regulatory Affairs Senior / Specialist in Submission Publishing Warszawa

For our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for a Regulatory Affairs Senior / Specialist in Submission Publishing who will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional and global regulatory agencies and operating companies in both eCTD and non-eCTD format. If you have relevant experience and would like to participate in the process, apply for this role.

What we expect

• Expert level knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines.
• Proficient use of Regulatory Information Systems, planning, and/or publishing tools.
• Fluency in English (C1) is a must.
• Ability to work or lead in a matrix environment.
• Awareness of interdependencies and skill to collaborate cross-functionally to publish and dispatch compliant submissions.

What we offer

• Annual performance-based bonus.
• Opportunity to work with a leader in the pharmaceutical industry.
• A tangible impact on regulatory processes and the development of innovative products.
• Hybrid work model (office in Warsaw).
• Additional leave benefits (e.g., bereavement leave).
• Comprehensive medical care and life insurance.
• Employer-sponsored retirement plan.

Utilizes regulatory information management systems and tools to assemble, publish, validate, dispatch and archive complex submissions according to internal processes and regulatory guidelines for paper and electronic submissions with a high degree of independence. Proactively interacts and supports RA and cross-functional partners for submission-related needs and issues, as required. Maintains open, timely, and effective communications with all publishing contributors and responsible regulatory affairs professionals to ensure timely delivery of submission components and/or complete submissions to release for dispatch to a health authority or distribution to a local operating company. Determines the scope of the electronic publishing requirements for the submission. Interprets and enforces paper and electronic regulatory submission standards, policies, and operating procedure requirements. Manages multiple high complexity submissions simultaneously with a high-degree of independence.

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