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Regulatory Affairs Consultant- MAAs
6 dni temu
We are seeking a highly motivated and experienced Regulatory Affairs Consultant (MAAs) to join our team. As a Regulatory Affairs Consultant, you will provide operational regulatory support for assigned programs and activities. This role can be office or home based in various European locaitons.
Job Responsibilities:
Coordinate with other groups within Regulatory Affairs to finalize and ensure timely dispatch of Health Authority submissions as aligned with assigned program Regulatory Affairs sub-teams. Contribute to assigned Module 1 documents including forms and cover letters with oversight of the Regulatory Affairs program lead(s). Independently manage assigned regulatory compliance and maintenance activities for clinical trial, registration, and post-approval regulatory activities. Ensure tracking and update of relevant regulatory information in client compliance systems and trackers as provided by Regulatory Affairs sub-team representatives. Preparation of Regulatory Authority submissions on local level based on local requirements, as requested. Escalate or proactively inform the Regulatory Leader about any new local regulation or other issues that may impact the quality and/or timelines of submission/approval. Communicate Regulatory Authority application status and ensure any communication required with local regulatory authorities. Preparation, Review, and translation of Local Labelling according to local requirements and language. Import/export submissions if required in the country. Close collaboration with regulatory leader and iCRAs to ensure alignment in submissions and notifications. Qualifications: Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred. 3-5 years+ experience in an industry-related environment. Experience of post-approval regulatory processed and activities. Project management knowledge. Excellent interpersonal and intercultural communication skills, both written and verbal. Proficiency in local language and extensive working knowledge of the English language.-
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