Job Description


Regulatory Affairs 3-4 years Experience Medical Devices & Drug products

Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of company’s products.

Essential Duties and Responsibilities:
? Compile under supervision regulatory documents for submission
? Review, edit and proofread regulatory documentation
? Track of status and progress of regulatory documentation
? Assist in preparation and review of labeling, SOP’s, and other departmental documents
? Compile and prepare responses to regulatory authority’s questions
? Participate as an active team member of project teams as required,
? Maintain regulatory files in a format consistent with requirements
? Maintain awareness of regulatory requirements
? Responsible for label development, variation assessment
? Responsible to maintain trackers and database for regulatory affairs
? Responsible for regulatory documentation of adjoining South Asian Countries.

? Scientific knowledge
? Written and verbal communication skills
? Knowledge of regulations
? Technical systems skills (e.g. word processing, spreadsheets, databases, online research)
? Proofreading and editing skills
? Responsible to contribute to multiple projects from a regulatory affairs perspective
? Ability to multitask and prioritize Include the education and experience that is necessary to perform the job satisfactorily.

Education & Experience (Basic)
? Master’s degree (scientific area) / Bachelor’s degree (scientific area), Relevant experience 1-2 years.