ID: 111559
Regulatory Affairs Specialist
Geen aanbiedingen geplaatst
Omschrijving
Functieomschrijving
Role Description The EMEA Regulatory Integration Coordinator role reports to the Regulatory Integration Lead (RIL) EMEA who is responsible for adequate planning and resourcing of regulatory work to maintain compliance and continuity of supply from an end to end cross divisional perspective within the Europe, Middle East and Africa region. The Regulatory Integration Coordinator will partner with the RIL to ensure the Legal Entity Integration changes and MA transfers within scope of this project are planned, managed and executed timely and accurately, issues are identified and resolved, and opportunities for improvement are pursued. Scope of this project is EU regulated countries. Primary Activities: * Working closely with RIL and countries to collect and analyze regulatory intelligence that is required to develop a regulatory strategy for a specific project and perform impact analysis on this data to ensure the information is available for an optimal planning and execution the projects. * Under direction of the RIL, support the regulatory strategy, planning, execution and tracking of changes to include but not limited to: working with cross divisional groups (e.g. regulatory affairs, regulatory operations, Packaging sites and artwork teams, CMC, Supply Chain) to identify regulatory risks and enable earliest possible approval. * Work closely with cross-functional teams to provide country-level status and reporting. * Secure continuous follow-up & interaction with Countries RA and /or RAE on execution status and on tracking milestones achievements of the project plans.
Functie-eisen
BS/MS preferably in a science related to medicines with at least 5 years of working experience with a regulatory affairs function in the pharmaceutical industry. Demonstrated ability to work in a global regulatory environment, and with workflows associated with the preparation and submission of product filings, at the HQ and country level. Skilled in the management of complex and time-urgent project plans. Technically proficient in the use of tools to develop plans, manipulate spreadsheets, create reports. Demonstrated ability to collaborate and communicate across cultures. Demonstrated problem-solving ability, effective and timely decision-making, and negotiating skills. Ability to focus on customers, and has the candor, courage and willingness to listen and speak up.
Sollicitatieprocedure
Balans offers you a challenging and responsible job for the longer term. You have the opportunity to develop yourself and to work in dynamic and international teams.Do you have any questions regarding this vacancy? Please do not hestitate to contact Lieke van de Meerakker LL.M. on 31 (0)88-8900843. Are you an experienced laboratory professional and looking for the next step in your career? Balans Laboratorium mediates in a professional and thorough manner for senior scientists and managers with a laboratory or food background. If you are open to further broaden and deepen your career at a new employer, we suggest you visit our website to see how we can assist you in your search. If you want to leave us your details so we can contact you when we have an interesting position available for you, you can register via our website. Once you have registered, we will contact you within five working days to discuss your specific needs and wishes.
Role Description The EMEA Regulatory Integration Coordinator role reports to the Regulatory Integration Lead (RIL) EMEA who is responsible for adequate planning and resourcing of regulatory work to maintain compliance and continuity of supply from an end to end cross divisional perspective within the Europe, Middle East and Africa region. The Regulatory Integration Coordinator will partner with the RIL to ensure the Legal Entity Integration changes and MA transfers within scope of this project are planned, managed and executed timely and accurately, issues are identified and resolved, and opportunities for improvement are pursued. Scope of this project is EU regulated countries. Primary Activities: * Working closely with RIL and countries to collect and analyze regulatory intelligence that is required to develop a regulatory strategy for a specific project and perform impact analysis on this data to ensure the information is available for an optimal planning and execution the projects. * Under direction of the RIL, support the regulatory strategy, planning, execution and tracking of changes to include but not limited to: working with cross divisional groups (e.g. regulatory affairs, regulatory operations, Packaging sites and artwork teams, CMC, Supply Chain) to identify regulatory risks and enable earliest possible approval. * Work closely with cross-functional teams to provide country-level status and reporting. * Secure continuous follow-up & interaction with Countries RA and /or RAE on execution status and on tracking milestones achievements of the project plans.
Functie-eisen
BS/MS preferably in a science related to medicines with at least 5 years of working experience with a regulatory affairs function in the pharmaceutical industry. Demonstrated ability to work in a global regulatory environment, and with workflows associated with the preparation and submission of product filings, at the HQ and country level. Skilled in the management of complex and time-urgent project plans. Technically proficient in the use of tools to develop plans, manipulate spreadsheets, create reports. Demonstrated ability to collaborate and communicate across cultures. Demonstrated problem-solving ability, effective and timely decision-making, and negotiating skills. Ability to focus on customers, and has the candor, courage and willingness to listen and speak up.
Sollicitatieprocedure
Balans offers you a challenging and responsible job for the longer term. You have the opportunity to develop yourself and to work in dynamic and international teams.Do you have any questions regarding this vacancy? Please do not hestitate to contact Lieke van de Meerakker LL.M. on 31 (0)88-8900843. Are you an experienced laboratory professional and looking for the next step in your career? Balans Laboratorium mediates in a professional and thorough manner for senior scientists and managers with a laboratory or food background. If you are open to further broaden and deepen your career at a new employer, we suggest you visit our website to see how we can assist you in your search. If you want to leave us your details so we can contact you when we have an interesting position available for you, you can register via our website. Once you have registered, we will contact you within five working days to discuss your specific needs and wishes.