Job Description
A Good Opportunity for ..
• Effectively implement the company QA, SHE and REG policies and standards, guarantee the regulatory compliance to local and international laws and regulations in all concerned areas
• Account for all administrative matters such as budget, expenses, travel approvals, holidays etc.
• Act as first RA contact person in the country
• Report on local RA activity
• Report on critical deviations and claims
• Implement RA guidelines and procedures
• Coordinate RA activities among RA and Specialist Lines (QA, SHE, REG)
• Implement internal QA rules and coordinate QA activities in the Country
• Audit existing processes and improve QA standards in the Country
• Set up and standardize local QA process, guarantee full compliance of all goods, integrated with global QA and whole RA system
• Audit suppliers, forwarders, Elaborate, review, check and communicate QA related documents (reports, specifications, etc.)
• Elaborate, review and check classification of a chemical according to the chemical and transport regulations in place (Global Harmonized System for classification and labeling and the ADR, IATA, IMDG) along with the material creation process in SAP
• Harmonize classifications with SHE managers abroad
• Create and maintain the Safety Data Sheet of a chemical
• Keep informed about local, national, international legislation, including updates and revisions
• Inform local employees about the legislation
• Support requests for information from internal and external contacts according to corporate policies and procedures
• Maintain familiarity with local government regulations, policies and guidelines
• Visit conferences and local associations
• Prepare budget costs for registration and get internal approval for registration
• Ensure that all required elements for regulatory / registration filing are scheduled correctly and in place to meet the target filing, registration dates and the budget
Job Requirements
• Bachelor or Master Degree in Chemistry, Pharma or otherwise experienced and qualified
• Good knowledge of Quality Management System
• At least 5 years of experience in RA
• Strong communication skills
• English is a must (both written and spoken)
• Additional languages of the Region or country are an advantage