• Assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization • Coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements • Manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions • Assist the Global Regulatory Lead to manage GRT interactions • Support local regulatory activities (e.g. IND submissions and agency meetings) • Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead • Create and maintain product regulatory information and history documents through Amgen systems • Archive regulatory documents and agency communications • Collaborate with CRO’s / partners to support site initiation • Complete regulatory forms to support agency communications • Participate in GRT to support execution of regulatory strategy • Coordinate QC of regulatory documentation (e.g. briefing materials) • Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) • Assist in template development and maintenance • Respond to specific requests from and communicate relevant issues to GRT • Actively support regulatory compliance.

Role Description Reporting to the Director, Customs Compliance & Import/Export Operations, the Manager, Import Trade Compliance leads all U.S. import compliance activities, with a strong emphasis on duty drawback, tariff mitigation, customs governance, and adherence to U.S. Customs & Border Protection (CBP) regulations. This role requires extensive hands-on experience managing import processes, drawback programs, and compliance controls across the supply chain. The ideal candidate excels in classification, documentation accuracy, and optimization of import operations. This is a people leadership role. Responsibilities and Tasks - Oversee all import-related compliance activities to ensure adherence to CBP regulations. - Lead and manage the import compliance team, primarily responsible for all aspects of clearing entries into the United States as a self-filer. - Lead duty and tariff mitigation programs, including duty drawback, Free Trade Agreements, and use of the duty-free entry clause found in U.S. government contracts. - Manage HTS classification, country of origin determinations, valuation, assistance, and admissibility reviews. - Implement and maintain internal controls to ensure compliant and efficient import transactions. - Review and approve import documentation, including commercial invoices, packing lists, and entry summaries. - Address customs inquiries, CF28/29 responses, and support post-entry adjustments or protests. - Oversight and implementation of the ATF Compliance program and development of procedures. - Lead the company’s duty drawback program, including eligibility assessment, claim preparation, recordkeeping, and submission to CBP. - Identify opportunities to maximize duty recovery and streamline drawback processes. - Ensure compliance with all regulatory requirements and maintain complete audit-ready documentation. - Manage accelerated payment, unused merchandise, and manufacturing drawback claims. - Monitor regulatory changes affecting drawback programs and implement necessary internal updates. - Develop and maintain import compliance policies, SOPs, and audit frameworks. - Conduct audits of import transactions to identify gaps and implement corrective actions. - Manage relationships with customs brokers, freight forwarders, and other trade partners to ensure accurate and timely filings. - Support internal investigations related to import discrepancies, misclassification, valuation errors, or duty overpayments. - Provide expert guidance to procurement, logistics, supply chain, and finance teams on import requirements and cost-impacting decisions. - Deliver training on classification, documentation standards, and duty drawback processes. - Support operational teams in resolving import holds, PGA issues, and clearance delays. Qualifications - Bachelor’s degree in supply chain, international business, or related field. - Active U.S. Customs Broker License (preferred). - 5+ years of U.S. import compliance experience, including significant duty drawback responsibility. - Experience managing customs brokers and import service providers. - Deep knowledge of CBP regulations, ACE processes, PGA requirements, valuation methods, and HTS classification. - Strong understanding of drawback claims types and audit requirements. Benefits - Most locations offer a 9/80 schedule, providing every other Friday off. - Competitive compensation & 401(k) program to plan for your future. - Robust medical, dental, vision, & disability coverage with qualified wellness discounts. - Basic Life Insurance and Additional Life & AD&D Insurances are available. - Flexible Vacation & PTO. - Paid Parental Leave. - Generous Employee Referral Program. - Voluntary Benefits Available: Longer Term Care, Legal, Identity Theft, Pet Insurance, and more. - Voluntary Tricare Supplement available for military retirees.

Role Description As our company continues to grow we are seeking a Regulatory and Start Up Specialist to join our growing team. - Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. - Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. - Interaction with CA/EC for study purposes and handling responses to the CA/EC. - Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team. - Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership. - Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. - Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. - Customize country/site specific Patient Information Sheet and Informed Consent Form. - Responsible for/facilitates the translation and co-ordination of translations for documents. - Maintain communication with other key functions participating to country start up e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. - Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. - When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. - May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. - Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. - Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF. - May support the clinical team performing Pre-Study Site Visits. Qualifications - Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. - A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. - 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Requirements - Strong communication and organizational skills. - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. - Fluency in English. Benefits - We strive to ensure employees feel appreciated for the contributions they make every single day. - You will provide input and have your ideas valued and nurtured, impacting positive change for the company. Company Description Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

Role Description As our company continues to grow we are seeking a Regulatory and Start Up Specialist to join our growing team. - Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. - Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. - Interaction with CA/EC for study purposes and handling responses to the CA/EC. - Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team. - Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership. - Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. - Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. - Customize country/site specific Patient Information Sheet and Informed Consent Form. - Responsible for/facilitates the translation and co-ordination of translations for documents. - Maintain communication with other key functions participating to country start up e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. - Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. - When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. - May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. - Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. - Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF. - May support the clinical team performing Pre-Study Site Visits. Qualifications - Minimum Required: Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. - A qualification in Pharmacy/work experience as a Pharmacist would be highly beneficial. - 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. Requirements - Strong communication and organizational skills. - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. - Fluency in English. Benefits - We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. - We strive to ensure employees feel appreciated for the contributions they make every single day. - You will provide input and have your ideas valued and nurtured, impacting positive change for the company. Company Description Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.