Global Regulatory Labeling & Disclosures Leader
Sarepta Therapeutics Inc
Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products. You will partner with cross-functional teams to ensure compliant labeling, CCDS, and local labeling across regions. This on-site role offers the opportunity to shape regulatory strategy, manage IPD disclosures, and collaborate with Health Authorities and external vendors. #J-18808-Ljbffr Sarepta Therapeutics
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Labeling & Disclosures Leader in Cambridge, MA vacancy
- Sarepta Therapeutics seeks an Associate Director, Labeling and Disclosures to lead global labeling activities for development and marketed products.... ...cross-functional teams and Health Authorities to ensure regulatory compliance and strategic alignment. The role requires...RegulatoryWork at officeLocal area
- ...in the United States is seeking an Associate Director, Labeling and Disclosures to lead global labeling for development and marketed products and to... ...You will partner with cross-functional teams, ensure regulatory integrity, and drive compliant labeling strategies worldwide...RegulatoryWorldwide
$154.4k - $242.55k
...innofvation that are the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and...RegulatoryMinimum wageTemporary workLocal area- Takeda's Plasma-Derived Therapies (PDT) R&D Organization in Cambridge, MA is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to steer labeling strategy across US and EU. You will work with Clinical, Pharmacovigilance, Legal, and Commercial teams...Regulatory
- Akebia Therapeutics seeks a Director, Regulatory Affairs - Labeling to shape global labeling strategy across our portfolio. You will serve as the enterprise expert on labeling, partnering with Clinical, Medical Affairs, Commercial, Legal, Safety, and CMC to ensure robust...Regulatory
- Alnylam is seeking an experienced labeling professional to join our labeling strategy team. This team is responsible... ...or Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product,...RegulatoryLocal area
$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 work- Philips is seeking a Head of Regulatory for Ambulatory Monitoring & Diagnostics to lead global regulatory strategy, ensuring compliance across development and commercialization. You will manage a team of Regulatory Affairs professionals and drive risk mitigation, submissions...Regulatory
- ...Government Affairs, and Commercial teams to enable business growth while ensuring regulatory compliance. The role combines leadership in compliance with operational support, project management, and business enablement across a fast-paced, global #J-18808-Ljbffr Aptiv PLCRegulatory
$160.8k - $201k
...Importance of the Role The Associate Director, Labeling and Disclosures, will be responsible for leading global labeling activities for development and/or marketed... ...labeling, ensuring compliance with applicable regulatory requirements while supporting business and lifecycle...RegulatoryWork at officeLocal areaImmediate startWorldwide- Acrivon Therapeutics, Inc. in Watertown, Massachusetts is seeking a Vice President or Senior Vice President of Regulatory Affairs. This role leads global regulatory strategies for the oncology pipeline and ensures compliance with regulatory requirements. The ideal candidate...Regulatory
- State Street is seeking a Global Head of Market Surveillance Compliance to design and oversee a comprehensive, risk-based surveillance... ...to ensure robust, scalable surveillance aligned with regulatory expectations across jurisdictions. You will partner with Compliance...Regulatory
$212k - $333.19k
...you and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge office.At Takeda,... ...enterprise leadersCommitted to simultaneously driving regulatory approval as well as launch and global patient accessAbility...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workNight shift- ...Director of Epidemiology and Real-World Evidence Sciences to lead the global evidence strategy for Ipsen’s oncology assets across the product lifecycle. You will guide RWE generation and regulatory support, collaborating with Asset Teams, Biostatistics, and external partners...Regulatory
- ...Pharmaceuticals is seeking an experienced labeling professional to join our labeling... ...labeling regulations, and coordinate with regulatory, compliance, and operations to deliver submission... ...labeling components across US, EU, and global #J-18808-Ljbffr Alnylam PharmaceuticalsRegulatory
- Biogen in Cambridge, MA is seeking a Head of Regulatory CMC for Biologics & ATMPs. This hybrid role leads a global CMC regulatory strategy, aligning development, manufacturing... ...Operations, Quality, and Supply Chain. A senior leader with depth in regulatory sciences and biologics/...Regulatory
- Sanofi, a leader in biopharma and AI-powered science, seeks a Global Lead for Health Ecosystem & Innovation to build external partnerships with startups, academia... ...medical innovation while navigating a complex regulatory environment and global partners. #J-18808-Ljbffr...Regulatory
- Moderna seeks a Global Medical Director to lead medical affairs strategy across our Oncology portfolio, spanning early development through... ...generation, and cross-functional alignment, interfacing with regulatory, clinical, and commercial functions. The successful candidate...Regulatory
- Ipsen seeks a senior leader to guide the Global Asset Team in maximizing asset value from development to commercialization, spanning oncology indications... ...role requires shaping strategy, aligning across clinical, regulatory, commercial, and Medical Affairs, and reporting to...Regulatory
- AstraZeneca GmbH is seeking a Global Clinical Head (GCH), the most senior medical scientific expert on an asset/product team. The GCH... ...oversee all clinical scientific aspects, including clinical studies, regulatory submissions, and benefit/risk management. The role requires an...Regulatory
- ...Sanofi is seeking a Global Medical Director for Rare Hematology in Cambridge, MA. This medical lead oversees global medical strategy, alignment across clinical development, HEVA, regulatory, and market access to drive evidence generation and publications. The role requires...Regulatory
- ...headquarters. You’ll own end-to-end governance for global product launches and major lifecycle events,... ...activities with robust supply, quality, regulatory, and flow-of-goods strategies. You will partner with Asset Leaders and senior stakeholders to align commercial ambition...Regulatory
- Ipsen Group in the United States seeks a Global Brand Lead to shape and deliver the global brand strategy for an asset portfolio, aligning... ...acumen, and influence across Medical, Market Access, Regulatory, and Supply Chain functions. The ideal candidate will lead cross...Regulatory
- ...Development in Cambridge, MA is seeking a senior role to lead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring alignment with regulatory requirements and product lifecycle needs. The role emphasizes data-driven design, use of...Regulatory
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for... ...Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings....RegulatoryFull timeLocal area
- ...The Research Finance Manager is a senior leader at the intersection of finance, clinical... ...performance across Iterative Health's global research network — overseeing a team of... ...contractual requirements, and applicable regulatory standards. Performs related duties as requested...RegulatoryContract workTemporary workFor contractorsFor subcontractorH1bWork at officeLocal areaWork visa2 days per week
$177k - $278.08k
...changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$177k - $278.08k
...is to accelerate access to transformative medicines and make a lasting impact on patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Director, Global Regulatory Lead Oncology you will set...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$154.4k - $242.55k
...driven company to inspire you and empower you to shine? Join us as Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge, MA... ...documents, clinical protocols and documents submitted to Regulatory Agencies.• Establish and maintain scientific dialogue with KOLs...RegulatoryMinimum wageTemporary workLocal area$178.1k - $244.86k
...with local requirements.OBJECTIVES/PURPOSELead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle needsDrive data-driven and technology-enabled...RegulatoryMinimum wageTemporary workLocal areaNight shift
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Labeling & Disclosures Leader. Be the first to apply!
Related searches
- member team lead Cambridge, MA
- team leader production Cambridge, MA
- site leader Cambridge, MA
- team leader training Cambridge, MA
- team lead data science Cambridge, MA
- group strategy director Cambridge, MA
- market leader Cambridge, MA
- compliance team leader Cambridge, MA
- manufacturing team lead Cambridge, MA
- focus group leader Cambridge, MA