Regulatory Affairs Associate

Job Description

Our guiding principles are to protect the health and safety of our employees, and to protect our ability to make and supply medicines to patients. To reduce the risk of virus transmission, were taking measures to maximize social distancing by asking employees at Lillys facilities to work from home if possible, and by restricting travel. As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company subject to applicable law. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used throughout the recruitment process and will be on hand to answer any questions you might have. For more detail on what were doing at Lilly to make sure our employees and their families are safe, and to ensure people have access to Lilly medicines .Regulatory Affairs AssociateRiyadh, Saudi ArabiaReq IDR-33189TitleRegulatory Affairs AssociateCityRIYADHCountrySaudi ArabiaRegionResearch At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. Were looking for people who are determined to make life better for people around the world.Job summaryThe purpose of the Affiliate Regulatory Affairs Associate role is to execute the operational aspects of regulatory affairs for the marketing affiliate, including: * License maintenance activities (e.g. Labelling changes, CMC Changes, Renewals)* New registrations, line extensions and new indications.* Tracking regulatory procedures and archiving correspondence in accordance with local Saudi regulations and quality system requirements.* Provide operational excellence to successfully achieve Affiliate regulatory objectives.* Facilitate and cultivate relationships with relevant external regulatory personnel.Main Accountability/responsibilityRegulatory Plan Execution* Collaborate with the implementation of the Regulatory Plan in alignment with affiliate business plans as well as with regulatory requirements.* Support submission of high-quality regulatory applications within planned timelines.* Support dossier preparation of new applications to obtain marketing authorizations.* Coordinate administrative tasks (i.e. translations, legalizations, etc.) to facilitate dossier preparation.* Execute maintenance activities for marketing authorizations (timely submission of post approval maintenance activities like renewals, variations and periodic reports).* Support Dossier assembly in compliance with local regulations and quality system requirements.* Maintain awareness of current regulations and upcoming changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally.Regulatory Compliance* Keep internal Regulatory IT tools up to date and accurate* Ensure that all products & medical devices comply with local regulations and quality system requirements whichever is more stringent.* Keep the regulatory archive complete and up-to-date and ensure that all current licenses and labels are readily available* Support implementation of local quality system in line with the global quality system and local regulations.* Support internal/external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.* Raise awareness on compliance issues with leadership and relevant functions.Labelling* Perform the function of Affiliate Labelling Responsible Person, ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or MOH timelines.* Follow global labelling procedures and document relevant exceptions in order to produce accurate and high-quality Product Information which is in compliance with global core labelingProcess Improvement* Support implementation of relevant internal regulatory initiatives.Personal and Professional Development* Keep up to date on knowledge and understanding of local regulations and local, regional and global regulatory procedures, to include where applicable attendance to MOH meetings focused on regulatory/regulations* Keep up to date on trainings for professional development, to include external regulatory trainings* Ensure Performance objectives are completed in line with company process (MyPM)* Understanding and adherence to all company policies and proceduresKey Relationships*Internal* * Medical Team* Sales Team* Market Access Team* Marketing Team* HR team* Finance Team* Global Regulatory teams*External* * SFDA* MOH* Other Regulatory bodiesQualifications, Knowledge, Experience and SkillsEducational Qualifications Core: * Bachelors degree in Pharmacy.* Demonstrated ability to use Microsoft Office* Strong communication skills* Strong command of English language (written and spoken)* Ability to work within a team and deliver results* Planning & Organizing* Time Management* Must be legally allowed to work in KSA* Saudi Nationals only Desired: * Min of 2 years Regulatory experience* Good capability to establish positive networking both internally and externally.* Knowledge of Quality systems* Ability to adapt to difficult and different challenges Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively Lilly) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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