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Job Description
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies, authorities or to commercial partners, advise on the submission strategy
- Maintain regulatory files/database and chronologies in good order.
- Select and prepare CTD for products according to management instructions.
- Establish and maintain system for tracking changes in documents submitted to agencies, authorities or partners.
- Expertise proficiency with software tools and matrices for CTD submission.
- Review registration dossiers (countries specialized dossier or CTD).
- Contact with other departments inside and outside company to collect documents needed for registration files submission (R&D, Q.C., Marketing and Q.A.) such as: composition forms, analytical procedures, stability studies, insert leaflets, pricing approvals, etc).
- Negotiation and effective communication with agents and authorities to obtain timely product approval.
- Provide the regulatory reviews of customer complaints and defining the regulatory responsibility.
- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.
- Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes.
- Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
- Manage and train the registration team in regulatory policies or procedures.
- Provide guidance and feedback to management.
Job Requirements
- Bachelor of pharmacy or science.
- 2-3 years of experience in Regulatory Affairs.
- Expert in preparing CTD & E-CTD files
- Very Good Negotiation & Communication skills.
- Very Good Computer skills.
- Very Good Command of English Language
