Director, RA Global Regulatory Strategy
AbbVie
Director-level regulatory affairs position leading global strategy development and market approval efforts for neuroscience products. Responsible for managing cross-functional teams, regulatory dossiers, and lifecycle management while ensuring compliance with global regulations.
Responsibilities
- Lead Global Regulatory Product Team to develop creative strategies aligned with business objectives
- Develop and implement global regulatory product strategies for assigned products across lifecycle
- Interface with cross-functional teams to ensure clear strategic messaging in regulatory dossiers
- Proactively identify and mitigate regulatory risks; influence regulatory policy development
- Present regulatory assessments and recommendations to executive management and senior stakeholders
Requirements
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related field
- 7+ years pharmaceutical regulatory experience including US & C region drug development
- 5+ years strategic leadership role with strong project management capabilities
- Experience interfacing with major government regulatory agencies
- Strong global regulatory strategy development and implementation experience
- Excellent communication and negotiation skills in complex matrix environments
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Director, RA Global Regulatory Strategy in Cambridge, MA vacancy
- ...Instagram , YouTube , LinkedIn and Tik Tok . The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and... ...implement policies and procedures within the RA department. Under guidance from supervisor,...RegulatoryWorldwide
- Discover International is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to guide strategic labeling and ensure regulatory compliance for plasma-derived therapies. You will influence internal stakeholders across Clinical, Pharmacovigilance, Legal...Regulatory
$154.4k - $242.55k
...therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC... ...investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May...RegulatoryMinimum wageLocal areaRemote workWorldwideTakeda
Boston, MA2 days ago$190.4k - $285.6k
Job DescriptionGeneral Summary:The Director, Global Submission Management (GSM) is responsible... ...execution of a portfolio of global regulatory submissions across development and lifecycle... ...in alignment with global regulatory strategies and operational objectives. This role...RegulatoryFull timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA4 days ago$238.4k - $357.6k
...and motivated individual to join its Global Health Economics & Outcomes Research... ...Economics & Outcomes Research Senior Director will lead strategies and execution of evidence generation... ...comprehensive understanding of the legal and regulatory environment of the pharmaceutical...RegulatoryFull timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA3 days ago$252k - $378k
...Summary:The Medical Affairs Senior Director provides medical and... ...that scientific and medical strategies are aligned with broader corporate... .../regional insights in to global medical strategies and activitiesProvides... ...of global medical, regulatory and commercial (including payer...RegulatoryFull timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA2 days ago- ...status quo for the better. Chiesi Global Rare DiseasesChiesi Global... ...is what you will doThe Director, RWE is responsible for leading... ...and executing the global RWE strategy and vision for the Hematology... ...RWE leader across development, regulatory, and commercialization phases...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
Chiesi
Boston, MA3 days ago - Sanofi is seeking a Director for US Advertising and Promotion within Global Regulatory Affairs, based in Morristown, NJ or Cambridge, MA. You will guide day‑to‑day... ...direction, and interact with FDA to align promotion strategies. The role requires extensive regulatory...Regulatory
$212k - $333.19k
...DescriptionAbout the role:The Senior Director, Oncology Search & Evaluation... ...and supporting disease area strategy and early asset commercial... ...scientific, clinical, regulatory, and competitive insights into... ...to lead in a highly matrixed global environment. You will report...RegulatoryMinimum wageLocal areaRemote workTakeda
Somerville, MA2 days ago$192.4k - $302.39k
...and empower you to shine? Join us as a Director, Global Medical Lead, Zasocitinib- Psoriatic... ...ongoing optimization of the global medical strategy for zasocitinib in PsA, in alignment... ...recognizing local practice, access, regulatory, and stakeholder needs.Model Takeda values...RegulatoryMinimum wageWork at officeLocal areaRemote workTakeda
Somerville, MA3 days ago$154.4k - $242.55k
...lasting impact on patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global... ...Lead Oncology, you will define and lead global regulatory strategies for oncology programs, oversee major submissions, and guide...RegulatoryMinimum wageLocal areaRemote workWorldwideTakeda
Boston, MA1 day ago$180k - $245k
...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs... ...for developing and executing regulatory strategies that support global product development and registration...RegulatoryMonte Rosa Therapeutics
Boston, MA2 days ago$192.4k - $302.39k
...knowledge.Job DescriptionThe Global Medical Affairs Lead, PDT Immunology... ...a multi-year global medical strategy for the PDT immunoglobulin... ...Medical Affairs, clinical, regulatory, safety, compliance, regional... ...-based roles (e.g. Medical Director, Medical Science Liaison) is...RegulatoryMinimum wageLocal areaRemote workTakeda
Cambridge, MA1 day ago$149.2k - $254k
...Haemonetics is your employer of choice.Job Details:Haemonetics is seeking a strategic and highly influential Director, Global Healthcare Economics & Reimbursement Strategy to play a critical role in advancing our value-based selling capabilities across the hospital business...Hourly payFull timeTemporary workSummer workMonday to FridayFlexible hoursShift workHaemonetics
Boston, MA3 days ago$154.4k - $242.55k
...Job DescriptionJob Description Objective / Purpose Provides strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers, diagnostic tests, devices and digital health tools to...RegulatoryMinimum wageLocal areaRemote workTakeda
Boston, MA2 days ago- Job title : Director, US Advertising and Promotion, Global Regulatory Affairs Location: Morristown, NJ or Cambridge, MA About The Job As the Director, US Advertising... ..., labeling, product defense, and development strategies for assigned product(s). The Director is...Regulatory
$154.4k - $242.55k
...you to shine? Join us as an Associate Director, Global Biomarker Lead, Inflammation, GI2 TAU... ...implementation of translational biomarker strategies across preclinical and clinical-stage... ...protocols and documents submitted to Regulatory Agencies.• Establish and maintain...RegulatoryMinimum wageLocal areaTakeda
Boston, MA2 days ago- ...Role Senior Director of Global Health Economics & Outcomes Research (HEOR) leading strategies for Vertex's Hemoglobinopathies (Heme) portfolio through development, launch... ...; strong communication, technical, and regulatory knowledge. High-Value ~ focus on...RegulatoryFlexible hours
$154.4k - $242.55k
...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 works under the direction...RegulatoryMinimum wageLocal areaTakeda
Somerville, MA2 days ago- ...Rapport Therapeutics seeks an Associate Director of Regulatory Strategy to develop and execute regulatory pathways for a small-molecule neuromedicine... ...and primary contact with health authorities Monitor global regulatory landscape and communicate potential program...Regulatory
Rapport Therapeutics
Boston, MA4 days ago - ...Hi, Title: Associate Director Global Regulatory Affairs Location: Cambridge MA Hybrid position - 2 days onsite Duration: Long Term... ...Affairs – Labeling Lead to lead global labeling strategy and lifecycle management, with a primary focus on biologics...Regulatory
SoftPathTechnologies
Cambridge, MA2 days ago $169.4k - $266.2k
...deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Director, Global Scientific... ...of scientific communications strategy and deliverables, you will proactively... ...for sub-analysesCompliance and Regulatory: Excellent understanding of regulatory...RegulatoryMinimum wageFor contractorsFreelanceLocal areaRemote workTakeda
Somerville, MA1 day ago- ...Role: Associate Director, Global Regulatory Project Management and Strategic Planning in Oncology at Takeda, remotely based. Responsibilities... ...project management experience with global regulatory strategies and post-market activities HighValue: oncology, late-...RegulatoryRemote work
- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... .... This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate...Regulatory
$152k - $209k
...member of myGwork – the largest global platform for the LGBTQ+ business... ...neuroscience. The role of the Associate Director requires the ability to provide regulatory strategic advice primarily for U.... ...risk assessment, and mitigation strategies to various global and U.S....RegulatoryFull timeTemporary workWork at officeLocal areaBiogen
Cambridge, MA3 days ago- Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead global regulatory programs from its Cambridge headquarters or East Coast hubs. The role focuses on gaining market approval for mRNA infectious disease vaccines, leveraging global health agency interactions...Regulatory
- AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch, and... ...You will influence authorities and collaborate with global teams to shape regulatory strategies and compliance. With 6+ years in regulatory affairs,...RegulatoryLocal area
- Role: Global Strategic Insights and Forecasting Partner within the Strategic Business Excellence... ...-driven insights to support business strategy. Responsibilities: generate and... ...including Commercial, Medical, Market Access, Regulatory, Finance, and R&D; support global and...RegulatoryLocal area
- Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner with global clinical development teams to navigate milestones, submissions, and lifecycle activities. The...Regulatory
- Alnylam Pharmaceuticals seeks a Director of Regulatory Affairs, Global Labeling Strategy (US) to lead the US labeling function within the Global Labeling team. The role shapes CCDS, CPI, and TLPs, guiding evidence plans and negotiation pathways for multiple regions. You...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, RA Global Regulatory Strategy. Be the first to apply!
Related searches
- training and compliance manager Cambridge, MA
- director global regulatory affairs Cambridge, MA
- associate director compliance Cambridge, MA
- head compliance Cambridge, MA
- senior regulatory manager Cambridge, MA
- regulatory manager Cambridge, MA
- manager regulatory affairs Cambridge, MA
- compliance manager Cambridge, MA
- regulatory cmc manager Cambridge, MA
- regulatory affairs manager pharmaceutical Cambridge, MA