• Analyze and decompose regulatory frameworks and licensing requirements. • Support licensing and regulatory-readiness projects, including scoping, applicability analysis, gap assessment, evidence requests, policy review, application preparation, and remediation tracking. • Conduct first-line review of AI outputs for regulatory accuracy, evidence support, source traceability, and client suitability. • Convert unstructured requests into clear scopes and deliverables, including compliance analyses, and review reports. • Support compliance guidance, evidence checklists, submission-material mapping, and licensing deliverables. • Work as/with Engineering to build regulatory mappings, templates, review rules, evaluation cases, and structured AI workflows. • Escalate high-risk regulatory interpretations and final legal or compliance conclusions to senior reviewers or Legal.

• Lead and manage all regulatory licensing and compliance activities for the company’s satellite operations, including NOAA remote sensing authorizations and FCC/ITU spectrum, orbital, and satellite licensing requirements. • Lead and continuously improve the company's Export Control & Trade Compliance program, ensuring compliance with EAR, ITAR, and other applicable U.S. and international regulations. • Develop and maintain export classifications (ECCN/USML), licensing strategies, Technology Control Plans (TCPs), and export authorization processes for spacecraft, payloads, software, technical data, and related technologies. • Partner with Engineering, Mission Operations, Security, IT, and Product teams to integrate compliance requirements throughout the product development lifecycle, from design through launch and operations. • Serve as the primary compliance advisor for international collaborations, supplier engagements, technology transfers, foreign national access, and global business activities. • Oversee regulatory compliance for spacecraft development, launch campaigns, mission operations, orbital debris mitigation, and other evolving space industry requirements. • Establish governance frameworks for controlled technologies, engineering environments, software repositories, technical data, and mission operations systems. • Collaborate with Legal, Supply Chain, Business Development, and Program Management to ensure compliance requirements are incorporated into contracts, supplier agreements, customer engagements, and strategic partnerships. • Provide guidance on regulatory and compliance risks related to international business, mergers and acquisitions, strategic investments, and technology partnerships. • Monitor emerging regulatory requirements and industry standards, advising leadership on business impacts and ensuring ongoing organizational compliance. • Deliver training, develop policies and procedures, and serve as the company's subject matter expert on export controls, regulatory compliance, and responsible space operations.

• Develop and execute the global regulatory product strategy • Lead GRTs • Represent Regulatory on the product team and other key commercialization governance bodies • Develop Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. • Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. • Identify and communicate regulatory risks • Represent GRA on the product team • Develop registration strategies and plans aimed at achieving regulatory approval and product labeling • Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent • Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes) • Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents) • Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment • Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy • Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood • Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams) • Attend key regulatory agency meetings which could impact the global product strategy • Represent Amgen Regulatory on external partnership teams at the product level.

Role Description Our Regulatory Affairs team brings essential generic quality medicines to U.S. patients by providing Regulatory leadership and establishing regulatory systems and processes that support Civica’s mission. The Associate, Regulatory Affairs Labeling and Artwork (remote position): - Supports all aspects of product labeling and artwork development, review, approval, implementation and maintenance for Civica’s private label distribution (PLD) products. - Follows labeling and artwork procedures that comply with FDA, GMP, ISO and other applicable standards and regulations. - Coordinates and prepares Office of Prescription Drug Promotion (OPDP) submissions as needed. - Works within systems to maintain labeling and artwork. - Owns or impact assesses change controls for PLD labeling impact. Responsibilities Include: - Coordinate labeling and artwork design by an external vendor. - Collaborate with the supply chain, contract manufacturers, packagers, and external vendors to ensure timely implementation of approved labeling changes. - Maintain labeling and artwork records within applicable electronic systems and document repositories. - Support preparation and submission of Office of Prescription Drug Promotion (OPDP) materials, as needed. - Maintain FDA drug listings information and associated regulatory records. - Participate in change control activities as a change owner, contributor, or impact assessor, as appropriate, to evaluate and implement labeling-related changes. - Review labeling components and artwork for accuracy, consistency, completeness, and compliance with approved regulatory content. - Ensure labeling information included in regulatory submissions is complete, accurate, and consistent. - Support continuous improvement initiatives related to labeling processes, systems, and workflows. - Perform any other tasks/duties as assigned by management. Qualifications - Proven experience in critically reviewing documents for consistency and accuracy. - Excellent proofreading/editing skills are required. - Strong organizational skills. - Demonstrated superior oral and written communication skills in multicultural settings. - Ability to communicate complex issues in a succinct and logical manner. - Strives to continuously improve and build knowledge and skills. Requirements - Bachelor’s degree required, focus in Life Sciences preferred. - At least one to two 2+ years of relevant experience within the pharmaceutical regulatory environment, with a concentration in pharmaceutical labeling and/or artwork development or promotional review. - Physical demands of the position include only those required for work in a typical office environment. - Minimal travel (0-5%) may be necessary in the execution of the listed duties. Company Description