Lilly Sr. RA Specialist in Seoul, South Korea
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. We’re looking for people who are determined to make life better for people around the world.
Regulatory Plan Execution
Implement the Regulatory Plan in alignment with affiliate business plans as well as regulatory requirements.
Ensure submission and approval of high quality regulatory applications within planned timelines. Maintain or support maintenance of clear metrics for Regulatory deliverables.
Preparation and support of new applications to obtain marketing authorisations.
Voicing affiliate perspective and needs to global and regional regulatory contacts.
Ensuring timely responses to requests from support groups and/or Regulatory Authorities.
Maintaining marketing authorisations (timely submission of post approval maintenance activities like renewals, variations and periodic reports)
Maintain Regulatory Tools in alignment with defined compliance metrics.
Support Affiliate launch Teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plans.
Represent the Regulatory Affairs function as appropriate in Affiliate Lead Team and New Product Planning discussions
Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally.
Facilitate interactions with regulatory bodies on a regular basis.
Ensure that internal Regulatory IT tools are up to date and accurate.
Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.
Ensure that the regulatory archive is complete and up-to-date and that all current licenses and labels are readily available.
Ensure implementation of local quality system in line with the global quality system and local regulations.
Support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.
Implement corrective/preventive actions as appropriate.
Provide regulatory quality oversight for Third Parties (i.e. Regulatory Services Providers, Translators, Graphic Agencies, etc.) as appropriate.
Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions.
Perform the function of Primary, Alternate or Delegate Affiliate Labelling Responsible Person (ALRP), 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 labeling
Ensure alignment and implementation of internal regulatory initiatives.
Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge.
Support implementation of launch readiness initiatives.
Build and maintain relationships with key regulatory officials (External Influence).
Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives.
Personal and Professional Development
Knowledge and understanding of local regulations and local, regional and global regulatory procedures.
Attend appropriate external symposia, workshops or conferences to develop technical expertise
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 ( LillyRecruitingCompliance@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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!