Regulatory Affairs Manager (Pharma) –

Titulo da Vaga: Regulatory Affairs Manager (Pharma)

Localização: Cascavel – PR

Descrição da Vaga: Detalhes da VagaEscolaridade Não InformadoSegmento Não InformadoSalário Não InformadoÁrea de AtuaçãoDiversos / OutrosO que você irá fazer

• Provide guidance to the company regarding regulatory requirements and ensure compliance with all relevant regulations.
• Submission and coordination with H.
• S.
• A.
• and with Regional RA APAC & RA HO.
• Collaborate with PIC for RA/QA of Business Partner/ Distributor in Hong Kong, Taiwan, and Brunei.
• Coordinate and liaise with necessary requirements for BE Study, CDP, BE site inspection, BE specific study.
• Facilitate critical submissions to H.
• S.
• A.
• as per commercial priority.
• Prepare a regulatory plan for submissions and renewals and ensure implementation as per agreed timelines.
• Provide up to date Registration status and estimated timeline for submission/ MA Approval.
• Proactively provide input on the current and upcoming New Regulation/Guideline and assess possible impact to registered/ upcoming registration product.
• Prepare documentation for GMP accreditation and monitor and record activities related to GMP.
• Provide support for all Pharmacovigilance / Quality Complaint Report.
• Recognize issues, roadblocks, and project risks, and proactively address these or raise to the attention of management with proposed solutions.
• Provide Technical support for Tender participation, Hospital listing and Medical enquiries.
• What you should do now Apply to this job ad or send your CV across to me at e.
• ng@brunel.
• net for a confidential discussion.

Informações AdicionaisQuantidade de Vagas 1Jornada Não Informado

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