Regulatory Affairs Associate - Maternity leave replacement

Apply now »Regulatory Affairs Associate - Maternity leave replacementDate: Aug 11, 2024Location:Tel Aviv, Israel, 1Company: Teva PharmaceuticalsJob Id: 57529Who we areTogether, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityTo lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements.How 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 market.Support customers regarding Service Requests, giving relevant professional information in the shortest of timeContinue learning of regulatory guidance, SOPs and work processesYour experience and qualificationsCapabilitiesGood human communications High service approach to internal & external customersGood Leadership and communication skillsOrganizedWide and open viewSelf- learning capabilitiesIndividual work abilityComprehensive workHigh writing skillsMeeting work target time linesAccuracyReadiness to work when requiredInitiativeSelf-motivatedTime managementEnglish good professional level, both in writing and speakingEducationHigh degree in relevant field, e.g. chemistry/biochemistry/biology or biotechnologyReports ToMgr Regulatory Affairs, RA|IL(TAPI RA)Already Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career SiteThe internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Teva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.Apply now »