Sr. Executive/Executive, Global Regulatory Affairs

M.Pharm or M.Sc. in Biochemistry/Chemistry.

(2-3) years of related (Global Regulatory) experience is preferable

Well conversant in MS Office.

Good interpersonal and communication skills.

Strong personal & professional ethical values are essential for the position.

Capable to work in a team and in shifting environment.

Responsible for preparing registration dossiers (e.g., CTD, ACTD, etc.) in accordance with the specific requirements of various countries.

Possess expertise in various validation activities, including process validation and analytical method validation (e.g., Assay, Dissolution, Impurity, Residual Solvent, etc.), to check document from QC and PD.

Manage and address queries and deficiencies (e.g. NODs) received from foreign drug authorities.

Conduct comprehensive data checks, covering stability, specifications, standard test methods, standard operating procedures, Certificates of Analysis, Batch Manufacturing Records, Formulations and Batch Packaging Records, while performing gap analysis through document reviews from QC, QA, production, and engineering departments.

Demonstrate a deep understanding of various regulatory guidelines such as ICH, WHO TRS, and PICS, among others.