Global Labeling Director - Regulatory Affairs (Hybrid)
EMD Serono, Inc.
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 over 8 years of pharmaceutical experience and a relevant Bachelor's or Advanced degree. The position offers a hybrid work model, requiring onsite presence 3 days a week in Billerica, MA. A strong track record in regulatory affairs and excellent communication skills are essential for success in this role. #J-18808-Ljbffr EMD Serono, Inc.
$182.1k - $273.1k
...MassachusettsShift: NoDepartment: HC-RD-RRF Regulatory Affairs for Advertising PromotionRecruiter:... ...are looking for.Your Role:The Director of Global Labeling (Director of GL) provides strategic... ...initiatives.Location Classification - Hybrid:This role will be required to work...SuggestedLocal areaImmediate startWorldwide3 days per week- EMD Serono, Inc. is hiring an Associate Director of Global Labeling in Billerica, MA. This hybrid position requires 3 days in the office. The role involves ensuring globally harmonized product labeling and managing cross-functional labeling teams. The ideal candidate will...SuggestedWork at office
$134.2k - $202.2k
...organization.Your Role:The Associate Director of Global Labeling / Labeling Product Lead (LPL... ...text in compliance with regulatory standards. The LPL supports country regulatory affairs (CRA) in creating national... ....Location: This is a hybrid, 3x/week in office position...SuggestedLocal areaImmediate startWorldwide$134.2k - $202.2k
...globe. Your Role The Associate Director of Global Labeling / Labeling Product Lead (LPL... ...text in compliance with regulatory standards. The LPL supports country regulatory affairs (CRA) in creating national product... .... Location: This is a hybrid, 3×/week in‑office position...SuggestedLocal areaWorldwideFlexible hours- SpringWorks Therapeutics in Massachusetts seeks a Director of Global Labeling to provide strategic regulatory labeling leadership for CCDS, USPI and EU SmPCs, guiding labeling content to align with product profiles and program goals. You will lead cross-functional labeling...Suggested3 days per week
$248k - $280k
...information, visit Position Purpose: The Director, Global Regulatory Strategy will be responsible for... ...: 8+ years minimum of Regulatory Affairs experience in the pharmaceutical industry... ...the end of 2026. This position is a hybrid position, currently based in Bedford...Temporary work$135.3k - $202.9k
...advancement across the globe.Scope: The Regional Regulatory Lead is responsible for the regulatory... ...local HA in this case.Contribute to the global regulatory strategy with local /... ...degree and at least 5 years of regulatory affairs strategy experience in drug development...Local areaFlexible hours3 days per week- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The role is hybrid and full-time, requiring a proactive regulatory mindset and collaboration with...Full time
$134.2k - $202.2k
....Your Role:The Senior Manager Regulatory CMC (RCMC) is responsible and... ...and serves as the Regulatory Affairs CMC contact point and acts as... ...Regulatory CMC topics.Location: Hybrid (3x/week) in Billerica, MA officeKey Accountabilities:Global Product Oversight: Ensures global...Local areaImmediate startWorldwide- Stoke Therapeutics seeks a Director of Global Regulatory Strategy to lead global regulatory planning, ensuring products move through development,... ...regulatory risk, and driving strategy across programs, with a hybrid schedule in Bedford/Will be based in Waltham. #J-18808-...
- Director of Global Campaigns, Hybrid CloudThis role has been designed as 'Hybrid' with a requirement that you will work on average 2 days per week from an HPE office.Who We Are:Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live...Full timeWork experience placementWork at officeLocal areaImmediate start2 days per week
- ...products organization in Burlington, MA to fill a Senior Director, Corporate Controller role. You will lead global accounting operations, oversee the month-end close,... ...leadership in manufacturing/CPG environments. Hybrid work arrangement in the Greater Boston area with...
- ...in the US. Your Role In your role as Compliance Officer in the Global Life Science, Electronics & Enabling Functions team, you will serve... ...to drive compliance innovation Location: Burlington, MA (Hybrid - 3x week in office) Travel: What we offer: We are curious minds...Work at office
- ...Healthcare Compliance Manager in Burlington, MA. This hybrid role (up to 3 days in office) supports the U.S. Legal and... ..., policy development, training, and collaboration with global stakeholders to ensure regulatory alignment and program effectiveness. #J-18808-Ljbffr...Work at office
- MilliporeSigma in the United States is seeking an Associate Manager Regulatory CMC to support all CMC regulatory activities, own the CMC... ...and lead dossier content decisions for worldwide submissions. Hybrid work in Billerica, MA, with responsibilities spanning strategy,...Worldwide
- ...Facebook, Instagram, X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is... ...and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory...Worldwide
$184.62k - $239.7k
...Location: Burlington, MA (hybrid with 3 days per week... ...are expanding our global presence with... ...Position Overview The Director, Regulatory Advertising & Promotion... ...aligned with approved labeling, and compliant with FDA... ..., regulatory affairs, or medical review focused...Full timeFixed term contractWork at officeFlexible hoursShift work3 days per week- ...About the job Global Trade Compliance Coordinator Job Summary Develop, implement... ...practices, under the direction of the Director, Global Trade Compliance. Evaluate... ...stakeholders to take corrective actions. Monitor regulatory changes globally and advise of risks,...Work at officeLocal area
$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients, aiming to... ...ensure the development of appropriate global and/or regional regulatory strategy(s... ...requirements to deliver the best possible labeling to meet the Medicine Profile,...Full timeLocal area- ...inspections for R&D projects or facilities. This hybrid role is based in Billerica, MA or Boston... ...readiness strategies, and maintain global inspection processes. Ideal candidates... ...(5+ in Clinical QA), and proven regulatory inspections knowledge; #J-18808-Ljbffr...
$66k - $82k
What You'll Do The Regulatory Affairs Specialist II supports regulatory submissions... ...Affairs personnel. Reviews labeling and engineering changes for... .... General understanding of global and U.S. regulatory... ...subject to applicable law. Hybrid position based in Bedford, MA...Full timeImmediate start- ...Compliance Officer to advise on ABAC, AML, and business ethics across Life Science, Electronics and Enabling Functions. The role covers global and US perspectives, applying the Compliance Management System and guiding risk assessments, policies, training, and case...Worldwide
- Anika is seeking a Regulatory Affairs Specialist II to support regulatory submissions, authority interactions, and post-approval activities.... ...manage multiple priorities in a fast-paced environment, with hybrid work based in Bedford, MA. #J-18808-Ljbffr Anika Corporation
$165k - $225k
...and we are rapidly expanding into global markets. As we scale, the regulatory compliance foundation that supports... ...Management team is seeking a Director, Global Product Compliance, to own... ...with localization requirements — labeling, documentation, and language requirements...Full timeLocal areaWorldwideFlexible hours- Novanta is seeking a Transfer Pricing Manager to support and scale our global transfer pricing compliance and operations. This role will own core recurring TP workflows, including quarterly adjustment calculations, documentation review, forecast support, and process standardization...
- ...business. You will guide cross-functional teams through complex regulatory requirements and maintain compliant processes. Reporting to the... ...licenses, classify products, train staff, and collaborate with global teams while maintaining records and supporting audits. #J-1880...
$259k - $317k
...patients we serve.Position Summary:The Senior Director of Regulatory Affairs is a senior leader responsible for developing and executing global regulatory strategy across the product... ..., statistical analysis plans, and labeling implicationsReview and provide regulatory...Full timeWork at officeFlexible hours- ...department description As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will... ...sections of drug product labeling. Represent Regulatory Affairs at... ...Achieve work‑life balance with our hybrid work model, allowing you to...Work at officeWork from home
$129k - $153k
...worldwide. Position Overview Regulatory leaders who leverage... ...scientifically sound, global, integrated regulatory... .../s Global Regulatory Affairs Strategy Team (GRAST)... ...plus other regional, labeling and CMC GRAST members... ...outcomes. This is a hybrid position based in Waltham...WorldwideRelocation package$232.5k - $335.83k
...Head of Strategy and Management Office, Global Clinical DevelopmentLocation:... ...risk mitigation strategies, internal and regulatory audit readiness, training and onboarding... ...characteristic protected by law.#GD-SP #LI-SP#LI-Hybrid#vhdPursue progress, discover extraordinaryBetter...Full timeWork at office
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