• 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

Role Description Black River Health is seeking an experienced 340B Compliance Program Lead to oversee our 340B Program, ensuring compliance with federal regulations while maximizing program performance and savings. If you're a knowledgeable 340B professional who thrives on collaboration, problem-solving, and regulatory excellence, we'd love to hear from you. Position Details: - Full-time (80 hours per pay period) - Monday–Friday, Day Shift - Benefits eligible - Remote eligible What You'll Do: - Ensure ongoing compliance with all HRSA 340B Program regulations and requirements. - Monitor regulatory changes and update policies and procedures to maintain compliance. - Oversee 340B program operations, including registration, purchasing, billing, inventory, and contract pharmacy compliance. - Partner with Finance, Revenue Cycle, Business Intelligence, and Pharmacy leadership to protect program eligibility and optimize savings. - Monitor 340B software, reporting, and records to ensure program integrity. - Provide education and guidance to staff and stakeholders on 340B compliance and best practices. Qualifications - Bachelor's degree in Business, Healthcare Administration, Pharmacy, or a related health field. - Knowledge of 340B Program regulations and compliance requirements. - Strong analytical, organizational, and cross-functional collaboration skills. - 340B ACE Certification within one year of hire. - Master's degree in Business Administration, Hospital Administration, Pharmacy, or a Doctor of Pharmacy (PharmD). - Three to five years of 340B compliance experience in a healthcare organization or health system. Benefits - Competitive pay - Comprehensive benefits - Opportunity to make a meaningful impact while serving your local community Company Description At Black River Health, you'll join a team committed to delivering outstanding, compassionate healthcare close to home. We value collaboration, professional growth, and the expertise our employees bring to improving the health of our community. If you're ready to lead a vital compliance program and make a lasting impact, we encourage you to apply. "Black River Health, Inc. is an equal employment opportunity employer functioning under an Affirmative Action Plan."