Regulatory Manager in WARSAWA

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Regulatory Manager in WARSAWA, Apply Lilly careers in WARSAWA .


Position : Regulatory Manager

Location : Warsaw, Poland

Job id: R-34022


Job Details

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.The purpose of the Regulatory Manager role is to manage all aspects of regulatory affairs for the marketing affiliate. Serve as link to European regulatory group and to national regulatory authority. The position covers a broad spectrum of regulatory activities – strategic, commercial and technical.In addition, Regulatory Manager is appointed:Product Quality Representative, who:ensures the implementation and execution of Lilly Global Quality Standards in particular CQP-181 in the marketing affiliateensures the implementation and execution of an adequate product quality system based on Lilly Quality Standards and any applicable local regulationscollaborates with Regional Quality Team to seek advice, inputs and guidance in all related quality matters/projectsResponsible Complaints Person and coordinates all activities related to Product Complaints handling according to required timelines defined for the type of report and the level of complaint.Recall Coordinator and ensures that a local strategy is developed for each recall, and the execution is conducted in accordance with the strategy and local regulatory requirements.Principal Records and Information Management Steward, who provides direction and decision making at the affiliate level for records management activities.Primary Responsibilities:Manage local regulatory activities on a day to day basis by:Preparing and supporting applications to obtain marketing authorizationsVoicing affiliate perspective and needs in applications to regional regulatory e.g. draft labellingMaintaining marketing authorizations (renewals, variations)Acting as a primary interface with the local regulatory agency, driving for solutionsProviding timely response to requests from the International regulatory groupCollaborating with GOLD (Global Operations Labelling Department) and drug safety with regard to CDS complianceInterpreting existing and proposed legislation with respect to local needs/relevance. Implementing new legislation in a timely fashionKeeping up to date with changes in local and global regulatory environment and the impact of regulatory requirements changes to affiliate business opportunitiesCommunicating local changes to appropriate GRA Management and functional expertsOrganizing the development of new packaging materials and approving new packaging materials (Affiliate Labeling Responsible Person)Being responsible for and using and updating corporate regulatory systems as necessaryContribute to the successful implementation of local commercial objectives byEstablishing and maintaining good relations with decision making staff in the local regulatory agencyBuilding and maintaining relationships with Medical and Marketing in the affiliate to facilitate cross-functional activities including submissions, review of promotional materials and timely update of labelling materials (as appropriate). Serving as a key resource within the business areaConsistently participating in affiliate cross-functional teams and providing regulatory input & knowledgeSupporting the affiliate business planning process, ensuring coherent planning for all regulatory initiativesAnticipating and resolving complex problemsProviding training and education on regulatory matters and providing regulatory input to documents as needed within the affiliate to improve and maintain understandingProviding technical support to the affiliate in pricing/reimbursement and/or legal activities (as needed)Supporting preparation and submission of local Risk Minimization Plan with related educational materials, and Direct Healthcare Professional Communication, in line with GPS instructions and local requirementsAttending affiliate meetings and supporting local pharma associationProduct Quality Representative:Implementation of the Product Quality System at the affiliate, covering but not limited to:SOP system, Quality Manual and related activities Documentation and DataDeviation systemChange control systemNotification to management systemCorrective and Preventive Actions (CAPA)Quality PlanQuality systems trendingRecalls managementProduct complaints managementGMP/Product Quality decisions in conjunction with Regional Quality TeamWarehouse and distributionPhysician samples handlingPromotional Materials with GMP impactProduct customizationAudit readiness & Follow up on audit findings and health authorities inspectionsInvolvement in projects linked to Quality Systems at the affiliate such as:Warehouse and Distribution management: distribution agreements & AuditsTransport providers management: quality agreements and auditsCold Chain AssuranceSerialization initiativesCustomization initiativesExternal parties for GMP activitiesRecall CoordinatorCoordinates activities required for the removal of the product from the market or suspending the batch distribution, in line with corporate and local regulatory requirements, as described in the affiliate recall procedure.Ensures that a local strategy is developed for each recall, and the execution is conducted in accordance with the strategy and local regulatory requirements.Communication with the local regulatory authorities, distributors, customer service, manufacturing site Quality Unit, Quality leaders and the management.Documents the recall actions and maintains records in the recall file.Affiliate Responsible Complaints PersonMaintain and enhance product knowledge, especially medical devices.Maintain compliance through good knowledge of company and regulatory guidelines concerning product complaints.Responsible for handling complaints and deciding measures to be taken at the marketing affiliate.Review and update the Product Complaints procedure, ensure proper implementation within affiliate.Coordinate all activities related to PC according to required timelines defined for the type of report and the level of compliant: receipt and registration of complaints, collection of required PC information and entry of complaint details in Trackwise System 290 Product Complaints Module, categorization of PC, forwarding the PC information to regional center for evaluation.Perform required attempts for retrieval of complaints sample, as required by GQS and local PC procedure.Assist the QA unit in investigation of the causes of PC, if needed.Providing a response to the customer based on the Complaint Report received from the manufacturing site and ensure complaint closure according to required timelines.Appropriate and timely cooperation with PhV Administrator, to provide accurate and complete information about the product complaint connected with Adverse Event/LODE case.Cooperation with Medical Information Coordinator to ensure customer feedback received at the affiliate is captured in global Customer Connect system.If required for specific complaint type, notify PQR, RQL or management.Ensure compliance with local regulatory and Lilly GQS and GPS standards, policies, procedures and processes.deliver the training on the product complaints reporting to affiliate staff and external partners.Principal Records and Information Management StewardRaise awareness with the affiliate of the Global Procedure on Records Management and the Global RIM Program for implementation and compliance to ensure that all records (including electronic and hardcopy) are retained according to the appropriate record series. Ensure the Annual Clean Up Day activities are held in affiliateEnsure the affiliate is in compliance with Lilly’s Global Procedure on Records Management, associated Global Records Retention Schedule, and Standard Operating Procedures (SOP). Inform Global RIM staff of any needed changes to the Global Records Retention Schedule (GRRS), Global RIM procedures, or additional services required of the records management program.  This includes notifying Global RIM of any changes in laws and regulations affecting their area’s records.Make sure the affiliate completes the annual “Self Assessment for Compliance”  form.Assist Global RIM in implementing processes to appropriately manage electronic records.Ensure Department RIM Stewards are assigned and trained.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 ( ) 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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