Regulatory Head for Daman Location

Job Description:

• 1) Review and comment on the deviation/changes with respect to its impact on the regulatory status and aspects.

   

  2) To communicate with MOH and other regulatory authorities regarding any notifications amendments, withdrawal for pre and post product approval.

   

  3) To ensure changes/deviations are complying to applicable regulatory requirement and expectations.

   

  4) To ensure registered and approved methods, facility and controls are used for holding, manufacturing, testing and packaging of the product of respective country.

   

  5) To review Stability Data in order to evaluate product shelf life/ storage conditions and applicable labeling requirements.

   

  6)  To ensure required studies are timely carried out for dossier submission.

   

  7)  To ensure required studies are timely carried out for dossier submission

   

  8) To ensure required samples are retained where applicable to support product registration/ studies.

   

  9) To participate in investigating issues related to quality complaints, adverse events during product lifecycle

   

  10) Responsible for filling dossier in prescribed formats of applicable countries.

   

  11) Responsible for risk assessment and reporting heavy metal impurities as per ICH Q3D for all materials and products.

   

  12) To review stability protocol and to ensure its compliance against requirements of intended market.