Global Regulatory Labeling & Ad Promo Lead (Hybrid)
Kailera Therapeutics
Kailera Therapeutics is seeking an Associate Director, Global Regulatory Labeling and Ad Promo in Waltham, MA to lead labeling strategy and cross-functional regulatory activities. This role focuses on U.S. labeling development, FDA interactions, and ensuring regulatory compliance across product lifecycle. Requires advanced degree with 5+ years in drug labeling or a 10+ year bachelor pathway; travel 10-15% anticipated. Compensation includes strong health coverage and bonus potential. #J-18808-Ljbffr
$154.4k - $242.55k
...Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived... ...industry (e.g., safety, ad promo, regulatory strategy, medical affairs... ...activities.Location: Cambridge, MA (Hybrid)Takeda Compensation and Benefits SummaryWe...RegulatoryMinimum wageLocal area- ...GlaxoSmithKline is seeking a Manager, Strategic Labelling & Development to lead the creation and maintenance of Global Datasheets for medicines, ensuring labeling... ...stakeholder management, and 2+ years in labelling/regulatory contexts. Based in the US, it offers bonus eligibility...Regulatory
- Moderna is seeking an Associate Director for Global Regulatory Advertising and Promotion to ensure regulatory compliance across promotional... ...staying current with FDA requirements and APBL guidance. You will lead PMRT/MRC discussions, support FDA interactions, and develop...Regulatory
$134.2k - $202.2k
...Your Role:The Associate Director of Global Labeling / Labeling Product Lead (LPL) ensures globally harmonized... ...packaging text in compliance with regulatory standards. The LPL supports country... ...development products.Location: This is a hybrid, 3x/week in office position based...RegulatoryLocal areaImmediate startWorldwide$134.2k - $202.2k
...Your Role The Associate Director of Global Labeling / Labeling Product Lead (LPL) ensures globally harmonized... ...packaging text in compliance with regulatory standards. The LPL supports country... ...development products. Location: This is a hybrid, 3×/week in‑office position based...RegulatoryLocal areaWorldwideFlexible hours- 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...Work at office
- ...About Freyr Freyr Inc. is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized global Life Sciences... ...industries. Job Title: Associate Director, Global RA Labeling Lead Job Type: Permanent Job Location: Princeton, NJ...RegulatoryPermanent employmentRemote work
$154.4k - $242.55k
...Associate Director, US Medical Ad/Promo Regulatory Review where you will serve... ...Provide product development and label development strategies, as... ...business unit/therapeutic areas. Lead internal Ad/Promo project... ...materials that are intended for global audiences (e.g., global press...RegulatoryMinimum wageFull timeLocal areaRemote workNight shift- ...Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-... ...development through post-marketing. This role supports hybrid in-office engagement amid relocation plans to...RegulatoryWork at officeRelocation
$177k - $278.08k
...several innovative medicines globally. We are looking for a... ...Launch Excellence Lead, you will work with a Product... ...Development, Global Regulatory Affairs, Global... ...global scale. This is a hybrid role based in Cambridge... ...Manage scheduled and ad-hoc program status reporting...RegulatoryMinimum wageFull timeLocal areaRemote workWorldwideFlexible hours- EMD Serono, Inc. in Massachusetts seeks an Associate Director, Global Regulatory Affairs Lead to own regional regulatory strategy and execution. This onsite role offers hybrid flexibility with a Tuesday-Thursday onsite presence. The ideal candidate will lead a regional...Regulatory
- Takeda is seeking a Global Medical Affairs Lead for the PDT immunoglobulin portfolio in Cambridge, MA, to co-lead a multi-year medical strategy... ...The role partners across R&D, Medical Affairs, clinical, regulatory, safety, and local teams to drive patient-centered...RegulatoryLocal area
- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure FDA and global promotional compliance across channels. You will serve as a liaison among Regulatory Affairs, Legal, Medical, and Commercial teams to align regulatory strategy...Regulatory
$182.1k - $273.1k
...MassachusettsShift: NoDepartment: HC-RD-RRF Regulatory Affairs for Advertising... ....Your Role:The Director of Global Labeling (Director of GL) provides... ...take on the role of Team Lead for a therapeutic area (TA),... ....Location Classification - Hybrid:This role will be required...RegulatoryLocal areaImmediate startWorldwide3 days per week$177k - $278.08k
...patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible... ...)In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain... ..."remote" in accordance with Takeda's Hybrid and Remote Work policy.#LI-Remote#LI-AA...RegulatoryMinimum wageLocal areaRemote workWorldwide$260k - $290k
...Head of Global Regulatory Advertising and Promotion Full-time Sobi... ...This role is responsible for leading and directing post-marketing... ...of 5 years as a regulatory Ad & Promo professional Experience in... ...aspects of drug development and labeling Advanced experience with...RegulatoryFull timeTemporary workWork experience placementSummer workWork at office- ...Kailera Therapeutics, Inc. in Massachusetts is seeking an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early/late phase products, writing and submitting IND/CTA amendments and future marketing applications, and guiding teams...Regulatory
- ...seeking a VP, Healthcare Compliance to architect and run the global healthcare compliance program as the company readies... ...teams to align policy, training, and monitoring with regulatory requirements. This hybrid Lexington, MA role requires 15+ years in compliance, a...Regulatory
- ...Merck in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs, optimize labeling, and shorten time to approval. You will manage global projects, interact with FDA/EMA, and coordinate...RegulatoryRemote workWorldwide
- ...Sanofi is seeking a Shipping Services Lead for Vaccines R&D in Waltham, MA. The role owns... ..., coordinating shipments, permits, and regulatory compliance while partnering with Quality,... ...improve efficiency and compliance across global Vaccines R&D operations. #J-18808-LjbffrRegulatory
- ...Sarepta Therapeutics is seeking a Global Regulatory Lead to drive high quality regulatory documents (INDs, CTAs, NDAs) and lead interactions with... ...teams, manages junior staff, and oversees budgets. Hybrid work on-site at Sarepta facilities in the United States is expected...Regulatory
$177k - $278.08k
...lasting impact on patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory... ...around the world.This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI...RegulatoryMinimum wageLocal areaRemote workWorldwide$178.5k - $257.83k
Job title: Global Periodic Reporting leadLocation: Cambridge, MA... ...Global Periodic Reporting Lead within our Pharmacovigilance... ...managing the annual worldwide regulatory planning of PSRs for the... ...by law. #GD-SG #LI-GZ #LI-Hybrid#vhdPursue progress, discover extraordinaryBetter...RegulatoryFull timeWorldwide- ...Takeda is seeking a Global Medical Affairs Lead in Cambridge, MA, to co-lead the global strategy for... ...The role partners with R&D, clinical, regulatory, safety and regional teams to deliver... ...education, and evidence generation in a hybrid work setting. The ideal candidate...Regulatory
- ...guiding cross-functional teams across development, validation, regulatory, and commercial workstreams. You will manage biopharma partnerships... ...extensive regulatory knowledge, collaboration with biopharma partners, and the ability to operate across global #J-18808-Ljbffr...RegulatoryRelocation
$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, Nephrology in our Cambridge, MA... ...strategies (e.g., Clinical, Commercial, Regulatory, PV, Health Economics and Outcomes, Market... ...position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid...RegulatoryMinimum wageWork at officeLocal areaRemote work- ...is seeking a Customs Manager to join the Global Tax team, focusing on US and cross-border... ...growth. You will monitor regulations, lead audits, and collaborate with Shipping and... ...efficient processes across the Americas with a hybrid work rhythm. This role requires...
- ...Senior Principal Medical Writer to lead end-to-end development of regulatory submission documents, ensuring scientific... ..., and timely delivery across global markets. You will serve as the primary... ..., shaping strategy and timelines. Hybrid role based in Billerica, MA with 3...Regulatory
- ...Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. You will... ...EMA and affiliates to accelerate approvals and optimize labeling. You will manage cross-functional teams, review regulatory...RegulatoryRemote workWorldwide
$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in our... ...Development, Clinical Science, Quality, Safety, Regulatory, Manufacturing, and Legal throughout -... ...position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid...RegulatoryMinimum wageTemporary workWork experience placementWork at officeLocal areaRemote work
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