G&L Scientific have an immediate need for Regulatory Labelling Specialists to join our team in India! Please only apply if you can start immediately. This role can be based in our Mumbai or Hyderabad Office 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 labelling documentation and change control records Safety signal assessments, creating and maintaining CCDS Experience in providing labelling support across study phases Supporting/leading Labelling Working committee groups/ Labelling review committee Performing detailed gap analysis of Product Information against regulatory reference products, to determine highest level of safety information Authoring updates using all relevant HA guidelines and latest templates Preparing variation packages Undertaking literature reviews Post-approval activities
G&L Scientific have an immediate need for a CMC Delivery Lead to work with one of our clients. Please only apply if you can start immediately and can accommodate EU working hours. This position can based in our Mumbai or Hyderabad office Key Skills and Experience Required: Demonstrated experience in CMC (Chemistry, Manufacturing, and Controls) for vaccines , with a solid understanding of regulatory and technical requirements. Proven ability in authoring CMC dossier sections for regulatory variations , including preparation, review, and management of Health Authority queries . Skilled in developing and writing CMC sections of Briefing Books to support regulatory submissions and meetings. Strong capability to identify and assess risks associated with submission data packages and proactively propose mitigation strategies. Effectively escalates issues with potential business or regulatory impact to line management, ensuring timely resolution and strategic decision-making.
Senior Regulatory Submissions Manager (2 openings – Immediate start) - Please only apply if you are an immediate joiner Location: Hybrid working from our office locations in Mumbai/Navi Mumbai/Hyderabad We are seeking two Senior Regulatory Submissions Managers to play a pivotal role in shaping how regulatory submissions are managed within our new Veeva RIMS platform. This is a high-impact opportunity to influence process design, system configuration, and regulatory compliance across a global organization. Duties will include: Define Submission Management Processes Lead the design and documentation of end-to-end Regulatory Submission Management workflows Partner across RA, QA, Clinical, and IT to identify process gaps and drive operational excellence Translate Business Needs into Veeva Configuration Convert business requirements into Veeva RIMS configuration specifications Collaborate with IT and Veeva consultants to ensure the system supports planning, tracking, publishing, and archival of submissions Ensure Compliance & Best Practice Alignment Align processes with Health Authority expectations and industry standards Maintain robust documentation of decisions, processes, and configurations Serve as SME & Project Contributor Act as Subject Matter Expert in workshops, design sessions, testing cycles, and UAT Help guide change management and end-user adoption Person Specification: Experienced in Regulatory Affairs and Submissions Management Hands-on familiarity with Veeva RIMS (or comparable regulatory systems) Strong communicator, collaborator, and process-thinker Comfortable influencing cross-functional teams in a global environment 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.
We are seeking three Global Regulatory Affairs Specialists to provide critical subject matter expertise and backfill internal SMEs during a major regulatory transformation initiative. These roles will ensure continuity of day-to-day regulatory operations - particularly across CMC, labelling, and lifecycle management activities. This opportunity can be located from our office locations in Mumbai and Hyderabad Duties will include: 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 Labelling Activities Review and update product labelling in accordance with regulatory and internal requirements Ensure alignment between approved labelling 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 Person Specification Experienced in Regulatory Affairs, ideally with exposure to CMC, labelling, 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 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.
This opportunity can offer hybrid working from our office locations in Mumbai, Navi Mumbai or Hyderabad Regulatory Operations / Data Quality / RIMS Implementation We are looking for five Senior Regulatory Data Analysts / Data Quality Specialists to support one of the most critical workstreams in our Veeva RIMS implementation: cleansing, standardizing, and preparing legacy regulatory data for migration. If you’re detail-oriented, analytical, and passionate about high-quality data, this role offers the chance to influence a global regulatory transformation. Duties will include: Regulatory Data Remediation Review, cleanse, and standardize legacy regulatory data Identify and resolve inconsistencies, gaps, duplications, and formatting issues Align data to Veeva’s defined data quality standards Data Migration Support Collaborate with IT, regulatory, and business teams throughout extraction, cleansing, and upload Validate migrated data to ensure accuracy, completeness, and compliance Data Quality & Governance Establish and monitor data quality checks and controls Support the development of data governance frameworks within Regulatory Affairs Documentation & Reporting Maintain clear audit-ready documentation of all remediation and migration activities Person Specification Experienced with regulatory data, lifecycle management, or RIMS (Veeva strongly preferred) Highly skilled in data analysis, cleansing, and quality control Process-driven, organized, and comfortable coordinating across global teams Passionate about data accuracy and regulatory compliance 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.
G&L Scientific have an immediate need for a CMC Delivery Lead to work with one of our clients. Please only apply if you can start immediately and can accommodate EU working hours. This position can based in our Mumbai or Hyderabad office Key Skills and Experience Required: Demonstrated experience in CMC (Chemistry, Manufacturing, and Controls) for vaccines or biologics with a solid understanding of regulatory and technical requirements. Proven ability in authoring CMC dossier sections for regulatory variations , including preparation, review, and management of Health Authority queries . Skilled in developing and writing CMC sections of Briefing Books to support regulatory submissions and meetings. Strong capability to identify and assess risks associated with submission data packages and proactively propose mitigation strategies. Effectively escalates issues with potential business or regulatory impact to line management, ensuring timely resolution and strategic decision-making.