● Obtain and distribute updated information regarding the related laws, guidelines, or standards from related organizations.
● Coordination and preparation of regulatory documents or submissions.
● Preparing 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.
● 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 work group or team.