Regulatory Affairs Specialist

Roche Pars

  • Full Time

  • Tehran

      -   Tehran

Regulatory Affairs Specialist

Posted 4 Month ago

Job Description

Summary: Assuring the fulfillment of all sanitary regulation requirements including those for export to Iran, to provide support on any regulatory affairs matters required for commercial operations. Developing, establishing, implementing, reporting and following up with all the local initiatives and corporate guidelines regarding regulatory affairs, giving support to other areas/functions about these topics. Your Responsibilities: •Coordinating every necessary activities for preparation and evaluation of registrations dossiers and legal documents associated, and to direct and coordinate regulatory activities related to preparation of files for the new products registration processes, modifications, renewals and technical evaluations requirements for registration of products in Iran where they are needed; asking Global Regulatory support, preparing and sending required documents and giving support to local organizations for registration processes, negotiating with authorities any problem related with registrations in process, to obtain the approval for initiate or continue the products commercialization. •Participating together or consulting with the Regulatory Affairs in Roche Diagnostics Middle East in local legislation and standardization, and to negotiate with in charge authorities the regulatory affairs that guarantee the establishment of an adequate regulatory environment for products to facilitate business growth and clearer communication in processes with authorities, in Iran. •Representing the company with local authorities and associations in affairs related to current legislation (product launching, regulatory activities, quality affairs, export etc.) •Monitoring the legal and regulatory developments including export regulations, changes or implementations in Iran. Establishing and maintaining contact with regulatory authorities. •Directing, compiling, evaluating and notify involved departments about reports of adverse incidents received through Global Regulatory & export control. Evaluating and notifying about adverse incidents that should be notified to the authority according to current legislation. •Actively support local organizations and marketing, sales and logistic departments to obtain documents related with regulatory affairs such as certificates, declarations, etc., needed ad required for tender processes, contracts and /or any commercial activity. Defining, implementing and monitoring a follow up system for all registers of Iran. Generating the reports required by the company regarding the areas under his/her responsibility. •Collaborating closely with the Legal, sales and Regulatory Affairs Manager in any projects or activities that the department requires. Performing other functions according to the requirements of the immediate Superior. Compliance •You are expected to adhere through your conduct to all applicable laws and regulations as well as to the high integrity standards as set forth by Roche •Representing the company in all the Audit/Inspection visits, keeping all the records for Audit/ Inspection visits and follow up all the required corrective actions through progress sheets. Aligning the warehouse procedures with local authorities. Maintaining the SC KPI.

Requirements

Who you are: •You have university degree with similar working experience in regulatory affairs in healthcare sector. For this position, you bring the following qualification: •Understanding and complying with applicable regulations and Company operating procedures, processes, policies, and rules. •Experience in preparing, performing, reporting and following up on regulatory processes. •Fluent in English and Farsi Language (written and Spoke) with computer skills, advance organization, proactive, dynamic and problem solving/decision making skills, working cooperatively and productively with others, building solid relationship with local authorities, focusing on the analysis and solution of problems, Intermediate level.

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