Global Oncology Regulatory Leader
$171.6k - $230.9kEMD Serono, Inc.
EMD Serono, Inc. seeks a Director of Global Regulatory Affairs to define and execute regulatory strategy for oncology programs. This role is pivotal in ensuring compliance and timely approvals with health authorities, emphasizing a strategic, data-driven approach. Located in Billerica, MA, the position requires onsite presence at least three days a week. A strong background in regulatory affairs in Oncology and an advanced degree are necessary. Compensation ranges from $171,600 to $230,900, based on experience. #J-18808-Ljbffr EMD Serono, Inc.
$221.6k - $305.4k
EMD Serono, Inc. is seeking a Senior Director, Global Regulatory Affairs to oversee regulatory strategy for multiple oncology programs. The role includes leading global submissions, managing a regulatory team, and aligning regional plans with program milestones. The ideal...Regulatory$134.2k - $202.2k
...MassachusettsShift: Department: HC-RD-RPO TA Oncology / ImmunoOncologyRecruiter: Sarah... ...organization.Your Role:The Associate Director of Global Labeling / Labeling Product Lead (LPL)... ...packaging text in compliance with regulatory standards. The LPL supports country regulatory...RegulatoryLocal areaImmediate startWorldwide$134.2k - $202.2k
...technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work... .... Your Role The Associate Director of Global Labeling / Labeling Product Lead (LPL)... ...global packaging text in compliance with regulatory standards. The LPL supports country regulatory...RegulatoryLocal areaWorldwideFlexible hours- ...a dynamic Senior Director of GMP Inspection Management to lead global inspection readiness across our manufacturing and testing network... ..., partners with CMOs, and drives continuous improvement in regulatory inspections and quality systems. You will oversee inspection strategy...Regulatory
- ...Director of GMP Inspection Management to lead the development of a global inspection readiness program. The role ensures proactive, risk-... ...years in GMP compliance and a proven track record with global regulatory inspections, capable of influencing across functions and...Regulatory
- Ultragenyx seeks an Associate Director of Global Inspection Management to drive a comprehensive global GMP inspection readiness program... ..., ensuring proactive risk-based readiness and excellence in regulatory interactions. The candidate will lead cross-functional teams, coordinate...Regulatory
$221.6k - $305.4k
...devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6... ...across the globe.Position Scope:The Executive Director, Global Regulatory Affairs oversees the regulatory strategy and execution for multiple...RegulatoryFlexible hours3 days per week$221.6k - $305.4k
Position Scope The Senior Director, Global Regulatory Affairs oversees the regulatory strategy and execution for multiple oncology programs globally, ensuring timely submissions and successful approvals while leading and developing a high-performing regulatory team. Key...Regulatory3 days per week- ...Trade Compliance Lead to define, lead, and scale the company’s global trade compliance program across regions. This role will embed compliance... ...systems and supply chain execution, ensuring alignment with regulatory requirements and business growth. You will own export controls,...Regulatory
$148.35k - $200.71k
...provider is looking for a Senior Manager in Global Compliance. This role involves... ...compliance, partnering with legal and business leaders, and expanding into enterprise... ...strong background in trade compliance, regulatory frameworks, and at least 10 years of experience...RegulatoryFlexible hours$150.15k - $250.25k
GSK Oncology is committed to discovering and developing new therapies with the potential... ...statistical sections of protocols, SAPs, clinical/regulatory documents, and presentations;... ...get ahead of disease together.GSK is a global biopharma company with a purpose to unite...RegulatoryFull timeInterim roleLocal area$127.9k - $191.8k
...technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work... ...to work in the US. Your Role The Global Labeling Excellence Lead is responsible... ...across global labeling activities within Regulatory Quality Safety (RQS). This role partners...RegulatoryFlexible hours$229.8k - $381.7k
...in therapeutic areas such as Oncology, Neurology and Fertility. Our... ...globe.Your role: In your role as Global Program Head (GPH), you hold... ...development, securing global regulatory approvals, ensuring market... ...extensive collaboration with leaders from internal and external development...RegulatoryFlexible hours3 days per week$174.6k - $262k
...technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work... ...US. Your Role:As a Medical Director in Global Clinical Development Oncology, you will... ...support for registration-enabling activities, regulatory submissions, and Health Authority...RegulatoryWork at officeFlexible hours- ...seeking a Senior Principal Medical Writer to lead end-to-end development of regulatory submission documents, ensuring scientific rigor, regulatory compliance, and timely delivery across global markets. You will serve as the primary writing lead within cross-functional...Regulatory
- Anika is seeking a Senior Complaint Specialist to manage global medical device complaints in a highly regulated environment from Bedford... ...will oversee intake, investigation, MDR determinations, and regulatory reporting to ensure compliant, timely, and well-documented outcomes...Regulatory
- ...vision is to build a world leading oncology company bringing the next wave... ...We are seeking a Program Team Leader (PTL) is a passionate drug developer with a global perspective and business orientation... ..., non-clinical, clinical, regulatory, CMC, and commercial strategies...RegulatoryTemporary workFlexible hours
- GlaxoSmithKline in the United States seeks a Senior Director, Global Regulatory Strategy - Oncology to lead regulatory strategies for asset development and lifecycle plans. The role collaborates with Early Development, Clinical, Safety, and Commercial teams to shape submissions...Regulatory
$251.61k - $377.42k
...Global Product Leader, Late CVRM – Weight ManagementAre you an inspiring leader with extensive experience in late-stage drug development? Do... ...external information on the product, including publications, regulatory documents, and clinical trial registers.• Manage and...RegulatoryHourly payFull timeTemporary workPart time- ...therapeutic areas including immunology, oncology and neuroscience - and products and... ...YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory... ...corporate goals are met. Key internal leader and driver of regulatory policy and...RegulatoryWorldwide
$167k - $300.7k
...:Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the rare, autoimmune and oncology portfolios. This is a newly created role... ...markets. The Director will be a strategic leader within Global Regulatory Science, responsible for...RegulatoryPermanent employmentFull timePart timeWork at officeWork from home- ...Biopharma is seeking a Senior Director, Global Medical Affairs to provide strategic leadership... ...and partner with Clinical Development, Regulatory, Legal/IP, and Communications. The... ...Affairs within biopharma, strong oncology expertise, and the ability to travel 50-...Regulatory
- ...Crescent Biopharma is seeking an experienced Senior Director, Global Medical Affairs to provide strategic and operational leadership... ...publication strategy. You will partner with Clinical Development, Regulatory Affairs, Legal/IP, and Corporate Communications to ensure...Regulatory
- Black Duck Software, Inc. seeks a Senior Manager, Global Payroll to lead and strengthen the company’s global payroll function for a PE‑backed cybersecurity SaaS business. You will oversee payroll execution, controls, vendor coordination, and audit readiness across Finance...Remote job
$134.2k - $202.2k
...share outside of the organization.Your Role:The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all CMC regulatory... ...: Hybrid (3x/week) in Billerica, MA officeKey Accountabilities:Global Product Oversight: Ensures global product oversight for the...RegulatoryLocal areaImmediate startWorldwide- BioTalent in Wilmington, Massachusetts, is looking for a regulatory professional to manage and resolve regulatory information requests, ensuring... ...compliance across various products. This role will influence global regulatory strategy and collaborate with teams to deliver...Regulatory
- Teledyne Technologies Incorporated is seeking a seasoned regulatory leader to manage the enterprise-wide Jurisdiction & Classification (JC)... ...business leaders across a diverse technology portfolio to ensure global compliance and consistent JC determinations. This high-...Regulatory
$257.5k - $333.5k
...and other safety-related documents and regulatory responses in collaboration with the Senior... ...knowledge of GCP, ICH guidelines, and global regulatory requirements. Minimum of 5... ...or as a Medical Monitor; experience in oncology and immunotherapy is preferred. Experience...RegulatoryWork at officeLocal areaFlexible hours2 days per week- EMD Serono, Inc. is seeking a Director of Global Labeling to provide strategic regulatory expertise for drug labeling. This role involves overseeing the development and approval of labeling documents while ensuring compliance with global standards. Candidates should have...Regulatory3 days per week
- Jobtailor is seeking a strategic regulatory labeling leader to guide cross-functional teams in developing core data sheets (CCDS), regional labeling... ...improvements. You will oversee labeling teams, interpret global requirements, and implement governance that ensures...Regulatory
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