Regulatory Affairs Coordinator- Temp Position

Company DescriptionAt TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we’re shaping the future of health worldwide.Our strength lies in our people—a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms livesJob DescriptionThe opportunityTo lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirementsHow you’ll spend your daySupport the life cycle management of APIs from RA perspectiveReview and approve ROS, specification and analytical control when requiredCoordinate DMF preparation and related activities for On Time Submissions for all relevant marketsProactively collaborates with the Regulatory Specialist team members, which support the submission or answer service requestsPrepare a DMF specific high level gap analysis report and proactively communicate any risk to the relevant departments. Follow up on the gaps' solving during the review periodRespond to deficiency letters and coordinate related activitiesCoordinating pre-launch activities from RA perspectiveManages the regulatory aspects and related tasks of the assigned commercial APIsEvaluate change requests and address the required submission per market to support the requested change. Follow through the submissionMaintain up to date the DMFs according to the required regulation of updating per marketSupport customers regarding Service Requests, giving relevant professional information in the shortest of timeContinue learning of regulatory guidance, SOPs and work processesQualificationsM.Sc./ PHD in a relevant field, e.g. chemistry/biochemistry/biology or biotechnology- MustEnglish Proficiency: Fluent in English, both written and spoken, at a professional level- MustTime Management: Effective time management skills and ability to prioritize tasksAttention to Details: Meticulous and accurate in work executionOrganization and Planning: Strong organizational skills and ability to meet deadlinesExcellent Communication: Strong verbal and written skills, both internally and externallyLeadership and Teamwork: Effective leadership skills and ability to collaborate effectively with othersCustomer-Centric Approach: Dedicated to providing high-quality service to both internal and external stakeholdersAdaptability and Learning: Open to new ideas, self-motivated, and capable of continuous learningInitiative and Proactivity: Takes initiative and is proactive in seeking solutions and opportunitiesAdditional Information*** Temporary position for 1 year ***