Lilly Senior Regulatory Associate in Istanbul, Turkey
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.
Senior Regulatory Associate
The purpose of the Regulatory Associate role is to obtain licenses for new products and maintain licenses for existing products on advice of the regulatory manager.
Perform local regulatory affairs activities on a day to day basis under supervision by:
Obtaining and maintaining product licenses for marketing affiliate by preparing and filing submissions to local regulatory agency, e.g. new products, line extensions, variations (Chemistry, Manufacturing and Control (CM&C), new indications, labeling etc.), renewals, co-marketing and GMP submissions for the inspections.
Supporting responses and issue resolution with regulators
Using and updating corporate regulatory systems
Maintaining complete archive of all MoH communications and all submitted and proposed documents (product dossier, approved labeling documents etc.)
Contribute to the successful implementation of local commercial objectives by:
Responding to queries on regulatory processes and regulatory status
Analyzing possible solutions to solve a range of regulatory problems
Becoming knowledgeable on all aspects of regulatory affairs and aware of national legislation and guidance as well as some areas of the latest regional legislation and/or ICH guidance if applicable
Using appropriate local and global SOPs and the applicable Lilly Quality Standards.
Performing labeling tasks such as development & submission & implementation of new packaging material, maintaining existing packaging material updates in due time
Act as ALRP (affiliate labeling responsible person) delegate:
Performing labeling tasks such as development of new packaging material, maintaining existing packaging material updated in compliance with Core Labeling and local regulatory requirements and approving packaging material through BLUE system for the products under responsibility.
Collaboration with GoLD (Global operations Labeling department) regarding safety and CDS compliance.
Submitting labeling changes in due time per instructions communicated by SAIL (Submission and implementation of labeling)
Relevant scientific degree or Bachelor's degree in pharmacy or life sciences (pharmaceutical, medical, chemical) is required
Minimum 5 years of experience in regulatory affairs
Very good command of English - written and verbal
Very good knowledge of MS Office applications
Effective communication skills to interact with diverse groups and individuals
Strong decision-making and problem-solving skills to impact own priorities and allocation of time to meet deadlines
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!