متخصص امور رگولاتوری

اروند فارمد

تهران

منتشر شده 23 روز پیش

Job Description

● Obtain and distribute updated information regarding the related laws, guidelines, or standards from related organizations. ● Coordination and preparation of regulatory documents or submissions. ● Prepare required information as requested by regulatory agencies. ● Prepare or maintain technical files as necessary to obtain and sustain product approval. ● Coordinate recall or market withdrawal activities as necessary. ● Advise the related teams on subjects such as regulatory and labeling requirements, or clinical study compliance issues. ●Review adverse drug reactions and the related reports in accordance with regulatory agency guidelines. ● Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. ● Identify relevant guidance documents and standards. ● Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. ● Participate in internal or external audits and doing the required follow-ups. ● Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

Requirements

● Bachelor's or Master's degree in Chemistry or related fields. ● 3 years of relevant work experience. ● Fluent in preparing and compiling CTD. ● Good English skills. ● Good ICDL skills. ● Attention to detail. ● Stress tolerance. ● Reliable, responsible, and dependable. ● Analytical thinking. ● Working with a work group or team.

Employment Type

  • Full Time

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