Contract: Permanent Full-Time Closing Date: 18/07/25 We are seeking experienced Regulatory Affairs Labeling professionals to join our global regulatory team. In this role, you will be working in a matrix team of global consultants, with responsibilities for one or more of G&L’s clients. You would be responsible for ensuring accurate and compliant product labelling in accordance with international regulatory requirements. Why Join Us? Competitive salary and Benefits package Hybrid working model (2 days per week at G&L’s office locations) Wide variety of projects, new challenges, and experience Start date Q3 & Q4 2025 The Role Key Responsibilities: Preparing and reviewing product labels, leaflets, and packaging for compliance with global regulations Collaborating with cross-functional teams, including regulatory, medical, and commercial Supporting product submissions, updates, and lifecycle management activities Maintaining labeling documentation and change control records Safety signal assessments, creating and maintaining CCDS Experience in providing labelling support across study phases Supporting/leading Labeling Working Committee groups/ Labeling Review Committee Performing detailed gap analysis of Product Information against regulatory reference products, to determine the highest level of safety information Authoring updates using all relevant HA guidelines and the latest templates Preparing variation packages Undertaking literature reviews Post-approval activities Requirements Skills & Competencies: Strong background in regulatory affairs, with specific experience in labeling Knowledge of EU, US, and/or global regulatory requirements Experience with Document Management Systems Working knowledge of Veeva Excellent attention to detail and communication skills Life sciences degree or equivalent experience Strong organizational skills with the ability to manage multiple projects Proactive and team-oriented mindset with a commitment to continuous learning Excellent working knowledge of MS Office Troubleshooting skills Flexible and adaptable, with innovative problem-solving abilities Expertise in interpreting regulatory requirements and determining compliance strategies How to Apply If you would like to hear more, please send your details to: [email protected] today! G&L is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process. G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity. View our current opportunities
Contract: Permanent Full-Time Closing Date: 05/12/25 We are seeking a Global Regulatory Data Standards Expert to lead the implementation and governance of ISO IDMP standards and ensure ongoing compliance with EMA requirements for structured medicinal product data. This role will also oversee XEVMPD submissions and support the transition to IDMP, playing a critical part in global regulatory data management. The Role Key Responsibilities: IDMP Implementation & Governance Lead adoption of ISO IDMP standards (ISO 11615, 11616, 11238, 11239, 11240) Define and maintain data governance frameworks for IDMP compliance Collaborate with EMA SPOR services (Substance, Product, Organisation, Referential) for alignment Support the transition from XEVMPD to IDMP and integration with PMS/SMS systems XEVMPD (Article 57) Compliance Manage submission and maintenance of product data in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) Ensure compliance with Article 57(2) of Regulation (EC) No 726/2004 and EMA guidelines Validate data quality using EVWEB and controlled vocabularies Data Quality & Standardization Oversee data mapping, cleansing, and enrichment for IDMP and XEVMPD Ensure controlled terminology alignment across regulatory systems Monitor and resolve data discrepancies impacting pharmacovigilance and regulatory submissions Regulatory & Cross-Functional Collaboration Serve as subject matter expert (SME) for IDMP and XEVMPD Partner with Regulatory Affairs, IT, and Data Governance teams to ensure system readiness and compliance Requirements Required Skills & Experience: Experienced in global regulatory data standards, IDMP, and XEVMPD (Article 57) compliance Strong understanding of EMA requirements and controlled terminology Skilled at cross-functional collaboration with Regulatory, IT, and Data Governance teams Detail-oriented, proactive, and able to influence global data strategies Why Join G&L?: This role offers the opportunity to work at the forefront of global drug development while embedded with a top-tier pharmaceutical client. You will gain exposure to high-impact projects, contribute to advancing innovative therapies, and play a strategic role in shaping regulatory pathways worldwide - all while being supported by our expert, global teams of consultants. If you're passionate about regulatory excellence and digital transformation in life sciences, we’d love to hear from you. How to Apply If you would be interested in joining the team at G&L Scientific, please send your CV to [email protected] today. G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
As a Global Regulatory Affairs Specialist at G&L Scientific, you will play a crucial role in providing subject matter expertise and supporting internal SMEs during a significant regulatory transformation initiative. Your primary focus will be on ensuring the continuity of day-to-day regulatory operations, with a specific emphasis on CMC, labeling, and lifecycle management activities. Key Responsibilities: - CMC Documentation Support: - Compile, review, and maintain Chemistry, Manufacturing, and Controls (CMC) documentation - Coordinate with Quality, Manufacturing, and regulatory teams to ensure accuracy and completeness - Labeling Activities: - Review and update product labeling in accordance with regulatory and internal requirements - Ensure alignment between approved labeling and market implementation - Regulatory Operations & Lifecycle Management: - Support preparation, review, and submission of regulatory filings - Ensure compliance with CHC regulatory standards, policies, and timelines - Contribute to lifecycle activities including variations, renewals, and maintenance submissions Required Skills & Experience: - Experienced in Regulatory Affairs, ideally with exposure to CMC, labeling, or lifecycle management - Detail-oriented, organized, and comfortable coordinating across multiple functions - Able to manage priorities in a fast-moving, global environment - Strong communicator with a compliance-focused mindset Joining G&L Scientific offers you the opportunity to work at the forefront of global drug development, embedded with a top-tier pharmaceutical client. You will gain exposure to high-impact projects, contribute to advancing innovative therapies, and play a strategic role in shaping regulatory pathways worldwide - all while being supported by our expert, global teams of consultants. If you are passionate about regulatory excellence and digital transformation in life sciences, we would love to hear from you. Apply by sending your CV to [email protected] At G&L Scientific, we recruit based on talent alone and firmly believe that an individual's background should play no part in the recruitment and selection process.,
As a Regulatory Process Design Manager/PMO Lead at G&L Scientific, you will play a crucial role in driving the redesign of future-state regulatory processes as part of the Veeva RIMS transformation program. Your combination of regulatory expertise and strong project and process management skills will be instrumental in ensuring the success of this initiative. Key Responsibilities: - Own all process-related tasks within the RIMS implementation initiative - Plan, track, and report on progress across multiple regulatory workstreams - Ensure redesigned processes align with regulatory requirements and system capabilities Define & Document Future-State Processes: - Lead workshops and working sessions with Regulatory Subject Matter Experts (SMEs) - Develop comprehensive process documentation, including workflows, Standard Operating Procedures (SOPs), and decision logs - Maintain clear traceability between current-state and future-state operations Governance & Change Management Support: - Support decision-making and escalation processes related to business process change - Collaborate with Change Management teams on communication, training, and adoption - Help ensure successful roll-out and integration of new ways of working Required Skills & Experience: - Regulatory Affairs expertise with a strong process design or operational background - Experience in managing large, cross-functional projects or PMO activities - Ability to translate stakeholder input into clear, structured processes - Strong communicator who can facilitate workshops and drive alignment G&L Scientific offers you the opportunity to work on high-impact projects in global drug development while collaborating with a top-tier pharmaceutical client. You will contribute to advancing innovative therapies and play a strategic role in shaping regulatory pathways worldwide. Join our expert, global teams of consultants and be at the forefront of regulatory excellence and digital transformation in life sciences. If you are passionate about making a difference in regulatory processes and driving digital transformation in the life sciences industry, we encourage you to apply by sending your CV to [email protected] At G&L Scientific, we recruit based on talent alone, believing that an individual's background should not influence the recruitment and selection process.,
As a Regulatory Data Quality Analyst at G&L Scientific, you will play a crucial role in supporting critical data remediation and migration activities as part of the RIMS implementation. Your focus will be on ensuring regulatory data integrity, compliance, and alignment with business needs. **Key Responsibilities:** - **Regulatory Data Remediation** - Review, cleanse, and standardize existing regulatory data - Identify and resolve inconsistencies, gaps, and duplications across regulatory systems and records - **Support Data Migration Activities** - Collaborate with IT and business teams to support extraction, cleansing, and upload processes into RIMS - Validate migrated data for accuracy, completeness, and compliance with regulatory requirements - **Data Quality & Controls** - Implement and monitor data quality measures to maintain ongoing integrity - Participate in audits and provide remediation plans as required - **Compliance & Governance** - Ensure all data handling activities adhere to internal governance policies and external regulatory expectations - Support development and enforcement of regulatory data governance frameworks - **Documentation & Reporting** - Maintain detailed documentation of remediation and migration activities - Provide regular updates on data quality status and migration progress to stakeholders **Required Skills & Experience:** - Experienced in regulatory data management, data quality, or RIMS-related projects - Detail-oriented with strong analytical and problem-solving skills - Comfortable collaborating across IT, regulatory, and business teams - Knowledgeable in regulatory compliance and data governance frameworks If you are passionate about regulatory excellence and digital transformation in life sciences, this role offers you the opportunity to work at the forefront of global drug development. You will be embedded with a top-tier pharmaceutical client, gaining exposure to high-impact projects and contributing to advancing innovative therapies. Additionally, you will play a strategic role in shaping regulatory pathways worldwide, all while being supported by our expert, global teams of consultants. Join us at G&L Scientific by sending your CV to [email protected] today. We recruit based on talent alone and firmly believe that an individual's background should play no part in the recruitment and selection process.,