Regional Export Control Officer and Quality and Regulatory Affairs Lead

Roche Pars Tehran

Posted a year ago

Job Description

Regional export control: The regional export control officer Middle East ensures compliance with international sanctions with respect to Roche diagnostics' business operations within the Middle East. The regional export control officer closely monitors adherence to all export control national laws and regulations of all countries where Roche is doing business as well as to the extraterritoriality of jurisdiction of the export administration Regulations and any Roche internal directives applicable to the trade of items. ● Manage export control against global EC regulation: implement or improve the company’s export control management and compliance program on-site with a special focus on the EC training program. - Customer screening: preparing red flag checklists and Roche Ender User Certificates (EUC) in alignment with distributors/3PLs. Performing background checks for new customers. - Supplier screening: monthly screening of the complete vendor list and all financial partners of embargoed countries and free zone areas. - GTS Screening and License application request: Prescreening of spare parts orders to prevent any blockage of restricted materials. Processing license applications like BAFA, OFAC, and BIS in close alignment with the global license application team - Material classification: verify if the item is eligible (meets all criteria) for importation or needs any special license (BAFA, OFAC, BIS). Identifying dual use products and products subject to EAR. ● Collaborate with regional supply chain and procurement functional teams to ensure trade activities are carried out efficiently and smoothly and associated records are maintained in compliance with CoreMap. ● Participate in relevant export control internal audits/assessments; report the findings and corresponding solutions to the line manager in time. Follow up on the corrective actions until the findings are corrected/improved/optimized to meet standards and requirements. ● Monitor the legal and regulatory developments including export regulations, changes, or implementations in the countries of the region. ● Define the local EC training plan, deliver training, monitor the training; ensure that manual screening procedures and tools are used, and conduct export control training to relevant stakeholders. ● Enable the complete and timely screening of local business partners; pay special attention to foreign trade business; oversee the local usage of the EC contractual clauses in procurement and sales. ● Escalates EC issues to the CECO in any case of red flags, suspected misuse of items, non-compliance violations, or any local enforcement activities by federal agencies.

Requirements

● 2 to 3 years of experience in managing export control processes. ● Experience in a regulatory role ideally in a multinational company. ● Bachelor's or Master's degree in Medical, Biomedical, Biochemistry, Biotechnology, or similar fields and at least five years of relevant regulatory and quality experience in the bio/pharmaceutical industry; or a Bachelor's degree in Supply Chain Management, Logistics, or Business Administration – preferably post-graduate degree in any related field. ● Demonstrated ability to work both independently and in a team environment. ● Well-developed teamwork, collaboration, and negotiation skills to communicate clearly and professionally both verbally and in writing. ● Proficiency in import and export regulations, especially in the regulation of FTZ (Free Trade Zone). ● Understanding local regulations on dangerous goods and GHS management. ● Quality management background. ● Self-starter, creativity, and organizational skills managing projects independently from start to finish. ● Fluent in English. ● Farsi is a strong plus. ● Arabic is a plus or any spoken language in the market.

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