Global Regulatory Strategy Lead - US & Canada
AbbVie Inc.
AbbVie Inc. in the United States seeks a Senior Manager Regulatory Affairs to lead regulatory strategy for US & Canada, ensuring alignment with GRPT and business needs. You will gather data to support filings and enable commercialization while liaising with Health Authorities and cross-functional teams. The role requires extensive regulatory experience, strong negotiation skills, and the ability to operate in a matrix environment across multiple locations, including Cambridge, MA, and other US #J-18808-Ljbffr AbbVie Inc.
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory Strategy Lead - US & Canada in Cambridge, MA vacancy
- AbbVie is seeking a Senior Manager Regulatory Affairs to lead Global Regulatory Strategy for US & Canada. You will shape regulatory plans for on-market and development products and ensure compliance with US/Canada requirements, coordinating with global teams. You will liaison...Regulatory
- AbbVie's Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada, is responsible for developing and implementing regulatory strategy for US and Canada, ensuring alignment with GRPT and regulatory requirements. The role interfaces with FDA and coordinates submissions...Regulatory
- AbbVie in the United States is seeking a Senior Manager Regulatory Affairs to lead regulatory strategy for US and Canada, ensuring timely submissions and compliance across therapeutic areas. The role requires collaboration across Regulatory, Clinical Development, Legal...RegulatoryWork at officeRemote work
$124.5k - $236.5k
Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada Full-time Salary Min: 124500 Salary Max: 236500 Workday Global Grade: 19 Compensation: USD... ...Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the...RegulatoryFull timeWork at officeRemote work- ...in Cambridge, MA seeks an Associate Director to define and lead global regulatory strategies for complex programs, providing strategic and tactical... ...FDA and global regulatory requirements. The role oversees US FDA submissions, stakeholder communications, and staff mentorship...Regulatory
- Takeda is seeking a Global Regulatory Labeling Strategy Lead for Plasma-Derived Therapies to drive strategic labeling across CCDS, US and EU labels while coordinating with internal stakeholders to ensure regulatory compliance and successful product evolution. This role...RegulatoryRemote job
- ...applicable law. Job Purpose The Director – US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs is responsible for leading the CMC Regulatory Affairs team with a... ...management, and post-approval regulatory strategy for FDA and internationally approved...Regulatory
Dechra
Boston, MA1 day ago $177k - $278.08k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program... ...solutions. Accountable for all US FDA submissions and approvals of... .... Knowledge of FDA, EU, Canada, ROW and post-marketing a plus....RegulatoryMinimum wageFull timeLocal areaRemote workRegulatory Toolkit
Boston, MA4 days ago$177k - $278.08k
...Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part... ...will set global regulatory strategy and lead major submissions... ...responsibility. Accountable for all US FDA submissions and... ...is a must. Knowledge of EU, Canada, ROW is a plus....RegulatoryMinimum wageFull timeLocal areaRemote workWorldwideRegulatory Toolkit
Boston, MA4 days ago- Sarepta Therapeutics is seeking a regulatory affairs professional for a US-based remote role. You will lead regulatory activities for clinical trials, coordinate submissions... ...-functional teams to implement regulatory strategies and ensure compliance with evolving guidelines...RegulatoryRemote job
- Takeda is seeking a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will serve as GRL on GPTs, coordinate with global teams, and ensure FDA submissions and other major filings...Regulatory
- ClinLab Solutions Group in Watertown, MA is expanding its regulatory capacity. The Global Regulatory Lead will take ownership of regulatory strategy and execution for an assigned program, reducing reliance on external consultants and closing timeline gaps created by competing...Regulatory
- Sarepta Therapeutics is seeking a Global Regulatory Lead to drive high quality regulatory documents (INDs, CTAs, NDAs) and lead interactions... ...periodic international meetings. You will craft regulatory strategies, ensure compliance, and guide teams through FDA engagements...Regulatory
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The... ...programs Implement compliance strategies and processes Prepare,... ...solutions. Accountable for all US FDA submissions and... ...requirements. Knowledge of FDA, EU, Canada, ROW and post‑marketing a...RegulatoryFull timeLocal area
- Alnylam seeks an Associate Director of Regulatory Affairs Strategy to lead regulatory strategy for early programs, coordinate submissions, and oversee US interactions with health authorities. The role requires cross-functional collaboration, multidisciplinary team involvement...Regulatory2 days per week
- ...Biogen is seeking a Head of Corporate Quality to lead its Global Quality Management System across US and international sites, including GMP and ICH conformance... ..., coordinating with R&D Compliance and senior regulatory bodies. The role combines strategic leadership with...Regulatory
- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience...Regulatory
$232.5k - $320k
## Global Brand Lead, NavtemadlinPostuler: Cambridge (US): Temps complet: Offre publiée aujourd'hui: R-22388**Titre :*... ...shaping and delivering the brand strategy for Navtemadlin, a Phase 3... ...across Medical, Market Access, Regulatory, Insights, Finance, Supply, Legal...RegulatoryTemporary workLocal areaFlexible hoursIpsen
Cambridge, MA2 days ago- Keurig Dr Pepper seeks a Manager, HR Compliance to lead compliance strategy across the U.S. and Canada, including governance, policy development, and risk... ...mitigation. This role partners with Legal Counsel, audits, regulatory reporting, HR policy development, and employee...Regulatory
- ...senior procurement leader to drive global strategy for Meetings, Conferences,... ...Travel, and Fleet. You will lead a team of category professionals... ...resilient supplier ecosystem, while advancing sustainability, regulatory compliance, and #J-18808-Ljbffr Jobleads-USRegulatory
- ...seeking a Senior Director, Brand Lead – US who will be responsible for... ...and executing the US brand strategy and commercial plan for ficerafusp... ...with Medical Affairs, Regulatory, Legal/Compliance, Market Access... ...in 2020, we've built a global team of over 100 employees headquartered...RegulatoryWork at officeLocal area3 days per week
Bicara Therapeutics, Inc.
Boston, MA2 days ago - ...Takeda is seeking a Global Launch Excellence Lead for a hybrid role in Cambridge, MA. You will... ...aligning with asset and brand strategies across Clinical Development, Regulatory, Manufacturing, Communications,... ...communication, and facilitation #J-18808-Ljbffr Jobleads-USRegulatory
$192.4k - $302.39k
...Job Description The Global Medical Affairs Lead, PDT Immunology is responsible... ...multi-year global medical strategy for the PDT immunoglobulin... ...Medical Affairs, clinical, regulatory, safety, compliance, regional... ...and weekends. More about us At Takeda, we are transforming...RegulatoryMinimum wageFull timeLocal areaRemote workWorldwideWeekend workTakeda Pharmaceutical Co.
Kendall Square, MA21 hours ago- Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, based remotely in the USA. The role partners with the Global Regulatory Lead to plan, coordinate, and deliver regulatory submissions across diverse programs...RegulatoryRemote job
- Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, based remotely in the U... ...Cambridge area. This role partners with the Global Regulatory Lead to ensure robust global project plans, cross-functional SWGs,...RegulatoryRemote job
- Moderna Associate Director, Global Regulatory-CMC will lead regulatory strategies for biologics or small molecules across lifecycle stages. You will shape global CMC plans, align with development teams, and drive submissions. The role requires 5+ years in biologics CMC,...Regulatory
- Takeda is seeking a senior commercial strategist to shape the global development plan for an investigational therapy in acute ischemic... ...vision, and the ability to align stakeholders across clinical, regulatory, and commercial functions. #J-18808-Ljbffr Takeda...Regulatory
- Sanofi in the US seeks a senior medical leader to... ...build and execute medical strategy across Rare Disease and... ..., and engaging with global medical partners to deliver... ...systems. You will lead talent, budget, and stakeholder... ...ensure compliance with regulatory standards while...RegulatoryHome office
- ...Expert to independently design, lead, and deliver global evidence studies across... ...sources. You will inform regulatory and payer decisions and advance... ...a hybrid work model across US locations. You will... ...while shaping asset evidence strategies through #J-18808-Ljbffr UCB...Regulatory
$176.1k - $238.2k
...continues to grow its presence globally, the Principal Specialist will... ...critical attributes that will lead to success in the role. A deep... ...field enablement and sales strategy. Support field teams in solution... ...to take pride in what makes us unique. Our inclusion events...Remote workFlexible hoursAmazon Inc.
Boston, MA2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Strategy Lead - US & Canada. Be the first to apply!
Related searches
- regulatory executive Cambridge, MA
- regulatory Cambridge, MA
- regulatory law Cambridge, MA
- regulatory technician Cambridge, MA
- regulatory scientist Cambridge, MA
- food regulatory Cambridge, MA
- regulatory cmc Cambridge, MA
- clinical research regulatory Cambridge, MA
- regulatory engineer Cambridge, MA
- regulatory contract Cambridge, MA