Job Title

About Freyr: Freyr is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized global Life Sciences companies. With a mission to accelerate compliance and enable businesses to bring their products to market faster, Freyr operates in a dynamic, innovative, and collaborative environment. Our team of experts works on cutting-edge projects that drive meaningful impact across pharmaceuticals, biotechnology, cosmetics, food, and medical device industries. At Freyr, we believe in fostering talent and creating an inclusive work culture where employees are empowered to succeed. Join a company that values innovation, integrity, and the power of collaboration. Position: Labeling Operations and Compliance - Manager Location: Remote (EST 9:00 AM 5:00 PM Support) Summary The Sr. Manager, GRA Labeling Operations/Compliance, will be responsible for leading packaging and artwork strategies across all commercial product lifecycles. This role will collaborate closely with cross-functional teamsincluding global packaging operations, manufacturing, engineering, regulatory, and supply chainto ensure robust artwork creation and implementation. In addition, the role will oversee other labeling operational tasks, manage vendor interactions for translation, SPL, formatting, and QC of labeling documents, and ensure compliance and audit readiness. Responsibilities Serve as the primary coordinator between regulatory strategy, regulatory labeling, and global packaging operations to ensure timely generation, review/approval, and delivery of commercial product label artwork across the entire product lifecycle. Manage review and approval of commercial product label artwork globally (primary packaging, e.g., vials; secondary packaging, e.g., cartons; and accompanying labeling such as prescribing information or patient information leaflets). Oversee feedback collection from local regulatory experts from initial marketing authorization submissions through the full product lifecycle. Coordinate artwork requests, including creation of local source documents for GLAMS, with support/review from Regional Regulatory Leads, in collaboration with Global Packaging Operations. Communicate labeling changes with the artwork department and align technical packaging requirements with regulatory restrictions, in consultation with local regulatory experts. Assign NDC numbers and ensure accurate integration across systems. Manage vendor coordination for labeling translations and review with local experts, including EMA linguistic review processes. Oversee SPL and XML document requests for submission, manage metadata, drug listings, and artwork with SPL vendors. Collaborate with SMEs (e.g., CMC colleagues) to initiate annual site registrations and recertifications. Perform QC for formatting and consistency in labeling documents (PLR checklist for the US, QRD templates for the EU). Utilize text verification and proofreading tools to compare labeling documents before submission, during negotiations, and after Health Authority approvals. Coordinate local feedback on commercial label artwork for country impact assessments in Veeva Quality, managing internal labeling change controls. Participate in regional supply management meetings to provide updates on upcoming artwork changes. Support audits and inspections by providing labeling documentation and ensuring traceability and accuracy of data. Identify and implement process improvements to enhance labeling efficiency, accuracy, and compliance. Requirements Bachelors degree in Life Sciences, Engineering, Business, Regulatory Affairs, or a related field. 68 years of experience in the biotechnology and/or pharmaceutical industry, with at least 3+ years in labeling operations or regulatory affairs. Strong knowledge of global labeling regulations (FDA, EU, and other regions). Proficiency in Microsoft Office and labeling systems/tools (Adobe, Veeva Vault, GLAMS, etc.). Excellent attention to detail, organizational, and communication skills. Strong project management abilities, with proven experience managing multiple priorities. Ability to work independently as well as collaboratively in a fast-paced, matrixed environment. What We Offer Competitive salary and benefits package. Flexible work environment (remote or hybrid options available). Opportunity to work with a global team and contribute to impactful projects. Continuous professional growth through training and development programs. Inclusive, collaborative, and innovative work culture. Why Join Freyr Be part of a global, fast-growing organization that operates in over 150 countries. Opportunity to work on impactful projects in a dynamic and innovative environment. Competitive salary and benefits package, including performance-based incentives. Flexible work options to support work-life balance. Continuous learning and professional development opportunities. Collaborative and inclusive work culture that values diversity.