Regulatory Affairs Manager - KSA

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** ------------------- **Educational Requirement:** Bachelor's degree in pharmacy field from a renowned institution / university **Relevant Experience \& knowledge:** * At least 5 years of experience in Regulatory Affairs field. * 3 years of solid Regulatory Affairs experience in a medium to large size reputable organizations. * Excellent in\-depth knowledge in different Regulatory Pathways for SFDA. * In\-depth understanding of pharmaceutical industry within the country. * Good knowledge of key business functions such as business development, market access, Medical, etc. * Must be able to work in a fast\-paced environment with demonstrated ability to deal with competing tasks and demands. * Excellent verbal and written communication skills. **Job Function and Description:** * In collaboration with International RA Strategists, provide regulatory strategies to responsible functional groups and regulatory management. * Prepare and submit Takeda’s product applications, variations, post approval reporting obligations and general product life cycle management support for Saudi Arabia. * Ensure that Takeda’s products comply with the registration of health authorities in Saudi Arabia. * Ensure appropriate evaluation of local business and regulatory registration requirements for investigational and marketed products and prepare regulatory assessment reports as needed. * Provide guidance/advice on international regulatory environments, provide assessment of the impact of new and changing regulations/requirements. * Develop effective working relationships with business partners and service providers in the Saudi Arabia, including local visits as needed. * Updates Takeda with the most recent registration requirements and procedures for manufacturers and products. * Receives the registration files and makes the final check before uploading on SFDA platform or forwarding to the local distributor for submission to the authorities. * Places the orders for buying chemicals and / or HPLC columns requested by the SFDA Laboratory. * Negotiate with the SFDA for product pricing on behalf of Takeda * Receives the final registration certificate of the product and / or manufacturing site. * Sends copy of the registration certificate and archives the original in the LOC. * Keeps records of all registration certificates and notifies IRA and local distributor six months before expiry so as to initiate the renewal process. **Locations** ------------- Riyadh, Saudi Arabia**Worker Type** --------------- Employee**Worker Sub\-Type** -------------------- Regular**Time Type** ------------- Full time