Senior Director, Regulatory Affairs Global Strategy & Submissions
$246.33k - $304.29kAkebia Therapeutics
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities in guiding key FDA interactions and overseeing submissions. The position offers a targeted base salary of $246,330 to $304,290, commensurate with experience. A flexible work model supports hybrid options, enhancing collaborative efforts within the team. #J-18808-Ljbffr
- ...Senior Manager, Global Regulatory Affairs (CMC) | Regulatory Strategy | CMC Submissions | Pharmaceutical R&D Role Overview Senior regulatory role within global R&D (Chemistry, Manufacturing & Controls – CMC) Responsible for executing regulatory strategy across clinical...Senior
$211.85k - $317.78k
...lives. This is what you will do: The Senior Regulatory Affairs Director (Sr RAD), Global Regulatory Strategy, leads the development and implementation of global... ...assets from early development through global submission and approval. May serve in a dual role as GRL...SeniorHourly payTemporary workWork at officeFlexible hours3 days per week- ...Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The... ...will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold...Senior
- ...Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Senior Director to lead the development of... ...and involves overseeing regulatory submissions and communications. The successful... ...significant experience in regulatory affairs and proven leadership in a matrix environment...Senior
$270k - $330k
...Position Overview The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory... ...flawless execution of regulatory strategies for both development and marketed... ...boards. Prepare and lead submissions such as PIP, scientific advice, orphan...SeniorTemporary workWorldwideFlexible hours$270k - $330k
...The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership... ...flawless execution of regulatory strategies for assigned products and projects... ...boards).Lead the preparation of submissions incl PIP, scientific advice,...SeniorTemporary workLocal areaWorldwideFlexible hours- ...A leading BioPharmaceutical company seeks a Senior Director, Global Regulatory Strategy, to lead regulatory efforts for early-stage products and ensure alignment with health authority expectations. The role demands extensive regulatory experience in the pharmaceutical...Senior
$177k - $278.08k
...JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience... ...with a strong focus on leading major submissions and ensuring regulatory compliance. This position...- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational... ...candidate will prepare regulatory submissions, interact with health authorities... ...role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...
$211.85k - $317.78k
...Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately...SeniorHourly payTemporary workWork at office3 days per week- ...Director Of Regulatory Affairs Monte Rosa Therapeutics is seeking an experienced... ...Affairs to lead and support global regulatory efforts across... ...and executing regulatory strategies that support global product... ...Lead the preparation, submission, and maintenance of regulatory...
- ...Job Title This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ..., registration and/or post-approval strategies for assigned products. RA CMC member... ...development of robust and accurate submissions. Develops constructive relationships...Senior
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy Introduction to role: Are you ready to set the global regulatory vision for pioneering cell and gene therapies... ...program, from current stage through BLA submission, ensuring an efficient route to...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$137k - $215.27k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls... ..., registration and/or post‑approval strategies for assigned products. RA CMC member... ...development of robust and accurate submissions. Develops constructive relationships...SeniorFull timeTemporary workLocal areaRemote workWorldwide$150.03k - $224.25k
...Provides critical support in developing global regulatory strategy, planning and execution of global... ...investigational and marketed prescription drug submissions and manages lifecycle activities for... ...2 years' experience in regulatory affairs or related areas (e.g., clinical...SeniorTemporary workWork at officeLocal areaFlexible hours- ...Noema Pharma is seeking a Director of Regulatory Affairs to lead the development and commercialization... ...products in clinical programs. This senior role requires a candidate with strategic... ...Director will develop regulatory strategies, interact with health authorities such...Local area
- ...Scholar Rock is seeking a Director or Senior Director of Regulatory Strategy in Cambridge, MA. This role involves developing global regulatory strategies, representing regulatory affairs within program teams,... ...ability to manage regulatory submissions and engagement with...
- ...Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy for complex oncology projects, with responsibilities that include overseeing FDA submissions and ensuring compliance with regulatory...Senior
- ...JobRx, Inc. is looking for a Director to define and lead global regulatory strategies in Boston, MA. The ideal candidate will manage the Global Regulatory Teams... ...with regulatory requirements, and oversee all FDA submissions. The role demands strong leadership, extensive...
- ...JobRx, Inc. is looking for a Director of Global Regulatory Affairs specializing in Neuroscience. This role... ...developing innovative global regulatory strategies and leading Global Regulatory... ...essential, as you will manage FDA submissions and collaborate with global teams...
- ...Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic... ...and executing regulatory strategies to support global product development, particularly... ...the ability to manage regulatory submissions and work with health authorities...
$245k - $300k
...Merida Biosciences in Cambridge, MA is seeking a Sr. Director, Regulatory Affairs to lead and execute global regulatory strategies. The ideal candidate will oversee health authority interactions, regulatory submissions, and strategic guidance for innovative therapeutics....- ...Cambridge, Massachusetts is looking for a Regulatory CMC Product Lead to independently develop and execute regulatory strategies for assigned products. You will... .... This role involves leading submissions, ensuring compliance with global regulations, and building relationships...
$137k - $215.27k
...for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or... ...discipline. Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a...Senior$210k - $235k
...development, commercial strategy, and beyond.... ...MA preferred The Senior Director/ Director Regulatory Strategy provides global regulatory leadership... ...sequencing of regulatory submissions. ~ Anticipate... ...experience in Regulatory Affairs within the pharmaceutical...SeniorRemote workWorldwideFlexible hours$212k - $333.19k
...worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where... ...and ideas into actionable strategies. You will set global... .... Accountable for US FDA submissions and approvals of project(... ...concepts within regulatory affairs and implications across the...SeniorMinimum wageTemporary workLocal areaWorldwide- ...Regulatory Strategy Senior Director page is loaded## Regulatory Strategy Senior Directorlocations... ...strategy for the assigned global or regional position and... ...including for regulatory submission documents and Health... ...status of global Regulatory Affairs strategies and tactics,...SeniorSummer workLocal areaRemote workFlexible hours2 days per week3 days per week
- Hemab Therapeutics is looking for a Director, Regulatory Affairs in Boston, Massachusetts. In this... ..., you will develop innovative global regulatory strategies for rare hematological disorders,... ...position involves leading regulatory submissions and communicating with health...
$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure... ...background in regulatory submissions. The position is based in...Senior$212k - $333.19k
...Senior Director, Global Regulatory Lead – Oncology At Takeda, we are a forward-looking, world-class R... ...challenges and ideas into actionable strategies. You will set global regulatory... ...leadership team. Accountable for US FDA submissions and approvals of project(s) of...SeniorMinimum wageFull timeTemporary workLocal areaRemote workWorldwide
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