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The Manager, Global Labeling Associate (GLA) focuses on end-to-end non-US/Central EU (Most of World) labeling development and implementation. This position provides innovation and technical expertise for the creation, maintenance and implementation of labeling to meet country-specific regulatory requirements and effectively manages labeling operations globally. Additionally, this role participates in a ‘follow the sun’ model for the review and escalation of differences in local labeling as they relate to the company core position. Key partner to GRA Regions, GRA GPS TA’s, Global Labeling Experts, GRA Regulatory CMC and End-to-End Supply groups. Supports cross-functional, end-to-end non-US/Central EU global labeling processes across the company utilizing cross-functional stakeholder partnership. Assesses labeling changes for MOW for differences in meaning and emphasis and participates in the respective labeling exception approval process with the Global Labeling Committee (GLC) nor non-US/Central EU labelling. Helps resolve issues between the countries and Product Care, Quality and Supply Chain related to artwork creation, translation and implementation through use of established processes, systems and best practices. Ensures consistent communication to the regions and countries regarding updates to CCDSs that will impact labeling revisions and related implementation. Leads the assessment and, as necessary, Global Labeling Committee (GLC) review of proposed exceptions between the CCDS and the MOW labeling when meaning and/or emphasis are changed utilizing established departmental processes. Escalates differences and issues to the Director, Global Labeling Operations as necessary. Remains up to date with the global labeling requirements and expectations. Represents Global Labeling in internal and external meetings as needed. Builds effective, cross-functional networks with GRA (regional and global) as well as across functions within Product Care, Quality and the End-to-End Supply Chain. University degree in Life Sciences or related Pharmaceutical field (e.g., Chemistry, Engineering); advanced degree (MSc, PhD or Pharm D) helpful. Biotech/pharmaceutical industry experience. This is inclusive of experience in labeling/regulatory experience combined with other global responsibility. Knowledge and understanding of principles of regulatory requirements relevant to drug development, global labeling and post-marketing requirements. Demonstrated problem-solving ability able to analyze risk and make appropriate recommendations/decisions. Must work well with others and within global teams, particularly crosscultural exposure. Experience working in a complex and matrix environment is required. Organizational skills to interact seamlessly both internally and externally on regulatory compliance matters. Proficient regulatory knowledge including an understanding of scientific concepts within labeling and implications across the organization and globally. Effective communication skills, specifically related to the explanation of concepts, options and impact. Attention to detail, coupled with the ability to think strategically. Fluency in English (verbal and written). CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit accessibility-statement. CSL Global Privacy Notice for Job Applicants and Candidates. #J-18808-Ljbffr

John Crane (www.johncrane.com) is a global leader in rotating equipment solutions, supplying engineered technologies and services to process industries. The company designs and manufactures a variety of products, including mechanical seals and systems, couplings, filtration systems and digital diagnostics technologies. John Crane customer service is accessed through a global network of more than 200 sales and service facilities in over 50 countries. Global reported revenue for fiscal year 2023 was in excess of $1.2 billion/1b GBP. John Crane is part of Smiths Group, a global leader in applying advanced technologies for markets in engineered components, energy, contraband detection, and communications. This senior role reports directly to the Materials Technology Manager and is responsible for ensuring that all John Crane products comply with applicable product regulatory requirements while providing strategic leadership on product regulatory compliance across the company. The role requires a broad understanding of global regulatory trends and emerging requirements, with responsibility for monitoring, tracking, trending, and interpreting regulatory developments that may impact the business. In partnership with cross-functional teams, the incumbent leads the timely implementation of new and revised regulations into company processes, products, and documentation, while ensuring that required product-related SDSs are authored, maintained, and readily available to all interested parties. • Leads the coordination and preparation of internal and external audits and compliance activities in accordance with applicable regulatory standards., • Provides senior-level guidance across the organization on product regulatory compliance matters and serves as a key resource and point of contact for internal and external stakeholders in support of John Crane products., • Responsible for the ongoing identification, monitoring, tracking, trending, and interpretation of relevant laws, regulations, and industry standards related to product regulatory compliance, and helps translate regulatory developments into practical business actions., • Performs timely product regulatory compliance and risk reviews throughout all stages of the product lifecycle and proactively collaborates with QHSE, Procurement, Sales & Marketing, Materials Lab, and other cross-functional teams to identify and mitigate potential compliance risks., • Oversees the collection, management, and analysis of product regulatory compliance data and supports the administration of documentation collection from suppliers to help ensure ongoing product regulatory compliance., • Provides the reply for product regulatory compliance-related customer inquiries and helps guide responses to compliance questions from internal and external stakeholders., • Authors product-related Safety Data Sheets, the implementation of product labeling programs, and raw material introduction programs, while helping ensure required product documentation remains accurate, current, and available., • Prepares external product registrations/certifications/notifications to support existing business and to secure business growth., • Partners with internal stakeholders to drive proactive compliance strategies, support training and awareness initiatives, facilitate readiness for regulatory agency inspections and other compliance reviews, and support corrective actions and continuous improvement activities across the company. Qualifications & Education • Bachelor’s degree in Chemistry, Chemical Engineering, Polymer Science, Environmental Science, Industrial Hygiene, or a related technical field required., • Master’s degree in Inorganic Chemistry or a related discipline preferred., • Significant relevant industry experience may be considered in lieu of a formal degree. Experience • Strong experience in global product regulatory compliance, product stewardship, or chemical regulatory affairs., • Proven experience working with global chemical regulations and product compliance frameworks. Core Competencies • Advanced knowledge of global product regulatory compliance principles, including:, • Chemical regulations (e.g., REACH, TSCA, GHS, etc.), • Safety Data Sheet (SDS) authoring requirements, • Hazard communication and product labeling standards, • Product stewardship practices relevant to industrial products (e.g., John Crane portfolio) Regulatory Expertise • Demonstrated ability to interpret and apply global, regional, and local regulations and industry standards., • Experience assessing regulatory impact on products and business operations., • Ability to identify emerging regulatory trends and compliance risks and support implementation of new or updated requirements across products, processes, and documentation., • Experience preparing and managing regulatory submissions in government-required formats. Technical & Functional Skills • Strong capability in:, • Regulatory data analysis and management, • Supplier documentation review, • Product lifecycle compliance assessments, • Raw material approvals and introductions, • Product registration/notification activities, • Ability to review and interpret:, • Product drawings, • Technical specifications, • Engineering documentation Cross-Functional Collaboration • Proven ability to collaborate effectively across functions, including QHSE, Procurement, Sales & Marketing, and Materials/Laboratory teams, to resolve complex compliance issues and drive regulatory alignment., • Skilled at influencing stakeholders and supporting cross-functional implementation of regulatory initiatives. Communication & Execution • Strong analytical, written, and verbal communication skills., • Ability to translate regulatory requirements into clear, practical guidance for internal stakeholders and customers., • Experience responding to customer and regulatory inquiries with accuracy and professionalism., • High attention to detail with strong documentation and recordkeeping practices., • Sound judgment in making risk-based, compliant decisions. Systems & Tools • Advanced proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)., • Experience working with ERP systems and regulatory data management tools. Certifications (Preferred) • Professional certification or specialized training in product stewardship, regulatory compliance, chemical management, or SDS authoring. Additional Attributes • Demonstrated learning agility and ability to adapt in a dynamic regulatory environment., • Strong project coordination and organizational skills. Additional Information With colleagues stretching across the globe, we are proud of our diversity. To foster inclusivity, we run employee resource groups (ERGs) to provide a safe space for employees to connect and support each other. Our cross-business ERGs include Veterans, Pride Network, Black Employee Network, Women@Work Network, and Neurodiversity. Across our company, we recognize excellence, culminating in the Smiths Excellence Awards, our annual celebration of the most extraordinary activities, people, and projects that best showcase our strengths and help drive our business forward. We announce these on our annual Smiths Day, a global celebration of Smiths around our network. Join us for a great career with competitive compensation and benefits, while helping engineer a better future. We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity. We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity. By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply #J-18808-Ljbffr

John Crane (www.johncrane.com) is a global leader in rotating equipment solutions, supplying engineered technologies and services to process industries. The company designs and manufactures a variety of products, including mechanical seals and systems, couplings, filtration systems and digital diagnostics technologies. John Crane customer service is accessed through a global network of more than 200 sales and service facilities in over 50 countries. Global reported revenue for fiscal year 2023 was in excess of $1.2 billion/1b GBP. John Crane is part of Smiths Group, a global leader in applying advanced technologies for markets in engineered components, energy, contraband detection, and communications. This senior role reports directly to the Materials Technology Manager and is responsible for ensuring that all John Crane products comply with applicable product regulatory requirements while providing strategic leadership on product regulatory compliance across the company. The role requires a broad understanding of global regulatory trends and emerging requirements, with responsibility for monitoring, tracking, trending, and interpreting regulatory developments that may impact the business. In partnership with cross-functional teams, the incumbent leads the timely implementation of new and revised regulations into company processes, products, and documentation, while ensuring that required product-related SDSs are authored, maintained, and readily available to all interested parties. • Leads the coordination and preparation of internal and external audits and compliance activities in accordance with applicable regulatory standards., • Provides senior-level guidance across the organization on product regulatory compliance matters and serves as a key resource and point of contact for internal and external stakeholders in support of John Crane products., • Responsible for the ongoing identification, monitoring, tracking, trending, and interpretation of relevant laws, regulations, and industry standards related to product regulatory compliance, and helps translate regulatory developments into practical business actions., • Performs timely product regulatory compliance and risk reviews throughout all stages of the product lifecycle and proactively collaborates with QHSE, Procurement, Sales & Marketing, Materials Lab, and other cross-functional teams to identify and mitigate potential compliance risks., • Oversees the collection, management, and analysis of product regulatory compliance data and supports the administration of documentation collection from suppliers to help ensure ongoing product regulatory compliance., • Provides the reply for product regulatory compliance-related customer inquiries and helps guide responses to compliance questions from internal and external stakeholders., • Authors product-related Safety Data Sheets, the implementation of product labeling programs, and raw material introduction programs, while helping ensure required product documentation remains accurate, current, and available., • Prepares external product registrations/certifications/notifications to support existing business and to secure business growth., • Partners with internal stakeholders to drive proactive compliance strategies, support training and awareness initiatives, facilitate readiness for regulatory agency inspections and other compliance reviews, and support corrective actions and continuous improvement activities across the company., • Bachelor’s degree in Chemistry, Chemical Engineering, Polymer Science, Environmental Science, Industrial Hygiene, or a related technical field required., • Master’s degree in Inorganic Chemistry or a related discipline preferred., • Significant relevant industry experience may be considered in lieu of a formal degree., • Strong experience in global product regulatory compliance, product stewardship, or chemical regulatory affairs., • Proven experience working with global chemical regulations and product compliance frameworks., • Advanced knowledge of global product regulatory compliance principles, including:, • Safety Data Sheet (SDS) authoring requirements, • Hazard communication and product labeling standards, • Product stewardship practices relevant to industrial products (e.g., John Crane portfolio), • Demonstrated ability to interpret and apply global, regional, and local regulations and industry standards., • Experience assessing regulatory impact on products and business operations., • Ability to identify emerging regulatory trends and compliance risks and support implementation of new or updated requirements across products, processes, and documentation., • Experience preparing and managing regulatory submissions in government-required formats., • Strong capability in:, • Regulatory data analysis and management, • Product lifecycle compliance assessments, • Raw material approvals and introductions, • Product registration/notification activities, • Ability to review and interpret:, • Product drawings, • Technical specifications, • Proven ability to collaborate effectively across functions, including QHSE, Procurement, Sales & Marketing, and Materials/Laboratory teams, to resolve complex compliance issues and drive regulatory alignment., • Skilled at influencing stakeholders and supporting cross-functional implementation of regulatory initiatives., • Strong analytical, written, and verbal communication skills., • Ability to translate regulatory requirements into clear, practical guidance for internal stakeholders and customers., • Experience responding to customer and regulatory inquiries with accuracy and professionalism., • High attention to detail with strong documentation and recordkeeping practices., • Sound judgment in making risk-based, compliant decisions., • Advanced proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)., • Experience working with ERP systems and regulatory data management tools., • Professional certification or specialized training in product stewardship, regulatory compliance, chemical management, or SDS authoring.#, • Demonstrated learning agility and ability to adapt in a dynamic regulatory environment., • Strong project coordination and organizational skills. With colleagues stretching across the globe, we are proud of our diversity. To foster inclusivity, we run employee resource groups (ERGs) to provide a safe space for employees to connect and support each other. Our cross-business ERGs include Veterans, Pride Network, Black Employee Network, Women@Work Network, and Neurodiversity. Across our company, we recognize excellence, culminating in the Smiths Excellence Awards, our annual celebration of the most extraordinary activities, people, and projects that best showcase our strengths and help drive our business forward. We announce these on our annual Smiths Day, a global celebration of Smiths around our network. Join us for a great career with competitive compensation and benefits, while helping engineer a better future. We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity. At no time during the hiring process will Smiths Group, nor any of our recruitment partners ever request payment to enable participation – including, but not limited to, interviews or testing. Avoid fraudulent requests by applying for jobs directly through our career’s website (Careers - Smiths Group plc) #J-18808-Ljbffr

• Leads or plays a key role in cross-functional teams for the review of safety data or safety-related reports, • Mentors and trains newer members of the functional area, • Ensures functions to comply with national and international regulations, such as GxP guidelines and/or any other relevant international and national legislation(s), regulations(s), and guidance(s) as well as company policies and procedures in area of responsibility, • Ensures direct reports to support and ensure QPPV’s oversight on the company’s Pharmacovigilance system, and identify, implement and monitor KPIs/KQIs across the company and manages cross functional CAPAs and other improvement activities on behalf of the QPPV., • Performs impact assessment of evolving pharmacovigilance legislations and propose or provide strategic direction for implementation of required changes to the global PV system. This may involve cross-functional approaches, including multiple interface functions., • Supports the preparation and conduct of PV and other GxP inspections and audits, as required and organize or support the back-office for regulatory PV inspections., • Maintain/contribute to regulatory required documents such as the PSMF, in line with international and national regulations, guidelines and internal standards., • Implements and supervise pharmacovigilance procedures as well as processes and ensures the uniform and timely processing and analysis of safety data to comply with regulatory requirements, • Ensure correct coding of all event and drug terms., • Ensure inter- and intra-consistency for case evaluations., • Participate in ICSR reporting compliance analysis and respective CAPA, • Together with Risk Management function develops and maintains Medical Concepts to support internal decision making and safety analyses for safety surveillance and provides expertise to pharmacovigilance and clinical development programs with regards to safety data/ SAE coding, • Manages regular MedDRA upgrades and provides impact analysis to RM physicians and ME, • Develop and provide advanced analytical outputs to global teams to support analyses and decision making based on safety data., • Development of new or enhancement of existing standard reports per company BT quality standards, • Gathers, details, and documents user requirements in a way that is useful and meaningful to their business area experts and the technical team implementing the solution, • Analyzes impact from changes to the database or change in user/reporting requirements, • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements., • Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary., • May support/contribute to cross functional BT projects to fulfill GxP requirements and to improve inspection readiness, • May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies, • Bachelor degree or equivalent in a life science discipline (e.g. nursing, biological, or pharmaceutical sciences), Medical Documentation, Master’s or PhD in life sciences., • 5+ years' Pharmacovigilance experience in multinational pharmaceutical industry., • Expert knowledge of local/international regulations and PV processes., • Knowledge of local/international relevant GxP regulations, IT standards and other relevant legislations such as legislations related to privacy protection., • Experience with regulatory inspections., • Experience in administration of complex data sets., • Experience in project-managing CAPA and SOP development., • Experience with relevant software applications., • Experience with GxP. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. #J-18808-Ljbffr

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Proclinical in the United Kingdom seeks a Senior Regulatory Consultant to steer global regulatory strategy for oncology and biotech portfolios, covering EU and international markets. You will work on lifecycle management, submissions, and cross-functional teams. The role requires deep regulatory experience, strong communication, and the ability to navigate complex regulatory environments across geographies; you will lead variations, PSURs, labeling updates, and ensure compliance. #J-18808-Ljbffr

Manager, Global Labeling Associate (GLA) to lead end-to-end labeling development and implementation outside the US/Central EU. This role supports global labeling operations, ensuring country-specific regulatory compliance and seamless cross-functional collaboration. The position requires strong regu

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