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Submission Publishing Expert
2 tygodni temu
Job Overview:
Regulatory Affairs Senior PositionWe are looking for a seasoned Regulatory Affairs Senior to join our team at Randstad Polska Sp. z o.o. This is a unique opportunity for a professional with a strong background in regulatory affairs and submission publishing.
The successful candidate will have extensive experience with various submission and application types, publishing templates, and relevant regulatory agency guidelines. They will be skilled in the use of Regulatory Information Systems, planning, and/or publishing tools.
The ideal candidate will be fluent in English (C1) and possess excellent communication skills, both written and verbal. They will be able to work effectively in a matrix environment and collaborate cross-functionally to publish compliant submissions.
Key Responsibilities:- Manage multiple high complexity submissions simultaneously with a high degree of independence.
- Proactively interact and support RA and cross-functional partners for submission-related needs and issues.
- Maintain open, timely, and effective communications with all publishing contributors and responsible regulatory affairs professionals.
- Determine the scope of electronic publishing requirements for submissions.
- Expert level knowledge of submission and application types, publishing templates, and regulatory agency guidelines.
- Proficient use of Regulatory Information Systems, planning, and/or publishing tools.
- Fluency in English (C1).
- Ability to work in a matrix environment and collaborate cross-functionally.
