• Define, lead, and personally execute global regulatory and product data strategies. • Hands-on management of product attributes, certifications, and country-specific compliance requirements across regulatory information management. • Ensure sustained compliance with global regulatory requirements and data accuracy for commercialization activities. • Establish, maintain, and execute global regulatory and product data governance frameworks. • Provide senior-level regulatory leadership while managing regulatory and product data for global submissions. • Perform and review data validation, reconciliation, tracking, and reporting activities for product portfolio. • Lead and support the design, implementation, and daily operation of global distribution control and transitional strategies. • Collaborate with cross-functional teams to enable compliant product releases and resolve issues.

• Responsible for the execution of divisional compliance policies in accordance with U.S. trade regulations (ITAR and EAR) • Provide compliance guidance to the business population • Authorize license and agreement applications • Manage U.S. Department of State and U.S. Department of Commerce license recordkeeping requirements • Review department export authorizations for accuracy and adherence to Corporate Trade policies • Implement and adhere to Corporate Trade policies • Review the applicability of Exemptions/Exceptions for the department • Responsible for the departments continued understanding of current USG authorization policies and requirements

Title: Associate Director, CMC Regulatory Affairs (Hematology/Oncology) Locations: Warren, Pennsylvania/ TARRYTOWN Cambridge, MA/ Uxbridge,England UK/ or Dublin, Ireland Regeneron Limerick (Ireland) Work Type: Hybrid, Full Time Job ID: R45185 Job Description: As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, supporting cross-functional and external partners, and serving as a key liaison in regulatory authority interactions. For US locations, this role is on-site 4 days in the office and 1 day from home. For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position . If eligible, we can offer relocation benefits. A typical day may include the following: - Lead product development activities from a CMC regulatory standpoint with input from senior management. - Represent CMC RA at program meetings and independently provide regulatory interpretation, position, and covering clinical development, initial market applications, and approval/post-approval activities. - Identify program issues and develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions/work-arounds, and obtain consensus. - Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics. - Lead and facilitate interactions with global regulatory authorities (e.g., meetings, IR responses, inspections). - Perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents; - Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks. - Develop and create working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups. - Identify gaps in the IOPS and global RA processes, bring up to higher management, and help to improve business efficiency. - Support establishing, managing, and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field. - Find opportunities to initiate operational changes and policy modifications. - Manage and coach team member(s). This may be for you if you: - Have a strong grasp of CMC worldwide regulations and guidelines. - Have been successful in building collaboration and teamwork across cross-functional teams. - Can demonstrate a proven track record managing and mentoring people. - Demonstrated skill in managing multiple priorities. To be considered a bachelor's degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience. An advanced degree is preferred. Proven track record supporting biological products through development and approval is a distinct advantage. It is required to have a good understanding of current CMC worldwide regulations and guidelines. Experience in interacting with the US FDA and other regulatory authorities. Experience with device regulatory requirements and development processes for combination products is a plus. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $157,200.00 - $256,600.00

Title: Senior Research Compliance Specialist - Research Cybersecurity Location: Atlanta United States Job Description: Job Number 165655 Job Type Regular Full-Time Division Research Administration Department Rsch Compl & Reg. Affairs Job Category Research Administration Campus Location (For Posting) : Location US-GA-Atlanta Location : Name Emory Campus-Clifton Corridor Remote Work Classification Hybrid Remote Health and Safety Information Not Applicable Discover Your Career at Emory University Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. Description JOB DESCRIPTION: - The Senior Research Compliance Specialist ensures institutional compliance with federal, state, sponsor, and university research regulations and policies. - This role conducts compliance reviews and risk assessments, supports investigations and issue resolution, provides training and guidance, and contributes to the development and continuous improvement of research compliance programs. - The position partners closely with faculty, research staff, and central administration to promote a strong culture of compliance and responsible research conduct. - Senior Research Compliance Specialists may be assigned one or more regulatory specializations based on institutional needs. - These specializations define the primary regulatory focus and required subject-matter expertise for the role, such as research integrity, controlled substances, research cybersecurity, or research security. - Conducts risk-based reviews, audits, and monitoring of research activities to assess compliance with applicable regulations, sponsor requirements, and institutional policies. - Supports and manages investigations and issue resolution related to research compliance, including documentation, analysis, reporting, and corrective and preventive actions. - Develops, implements, and maintains research compliance policies, procedures, guidance, and operational tools. - Provides training, education, and consultative support to faculty, research staff, and administrators on research compliance requirements. Prepares reports, metrics, and documentation to support compliance monitoring, program evaluation, and leadership reporting. - Maintains accurate and secure program records and ensures the integrity and confidentiality of sensitive information. - Collaborates with departments, committees, central offices, and external partners (e.g., IT, vendors) to support research compliance programs and enterprise systems. - Contributes to continuous improvement of research compliance programs and promotes a positive culture of compliance and responsible research conduct. - Performs related responsibilities as required. Regulatory Specialization: The Senior Research Compliance Specialist may be assigned one or more regulatory specializations based on institutional needs. Regulatory specializations define the primary regulatory domain and subject-matter expertise required for the role and do not change the underlying job classification. Research Cybersecurity • Supports compliance monitoring of secure research environments and projects involving Controlled Unclassified Information (CUI). • Participates in research cybersecurity and export control reviews to assess adherence to approved safeguards and data protection requirements. • Provides guidance and training on secure data handling, access controls, and research cybersecurity expectations. MINIMUM QUALIFICATIONS: - Bachelor's degree and five years of experience in research administration, research compliance, internal audit, legal, audit, or a related field. - Experience in a university or research environment involving heavily regulated industries preferred. - Juris Doctorate or master's degree and Certified Compliance and Ethics Professional (CCEP), Certified in Healthcare Research Compliance (CHRC), or similar certification preferred. NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department. This role requires residency in the state of GA. Emory reserves the right to change remote work status with notice to employee. Additional Details Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation.