Global Head of Regulatory Operations & Submissions
AVEO Oncology
AVEO Oncology is seeking an Executive Director for Regulatory Operations. This role involves providing strategic leadership for global regulatory operations, ensuring compliance and submission quality across the product lifecycle. The successful candidate will establish processes, manage a high-performing team, and oversee the end-to-end submission lifecycle including planning and quality control, while partnering with cross-functional teams to embed operational excellence. Experience with FDA, EMA regulations and extensive knowledge of electronic submission standards are essential for this role. #J-18808-Ljbffr AVEO Oncology
- Page Mechanical Group, Inc. is looking for an Executive Director of Regulatory Operations and Submission Management. This strategic role oversees the global regulatory processes ensuring high-quality submissions and compliance across the product lifecycle. The ideal candidate...Suggested
- ...company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and... ...will prepare regulatory submissions, interact with health authorities... ...is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...Suggested
- Mass Digital Health is seeking a Global Submission Lead in Cambridge, MA, or Morristown, NJ. This role focuses on planning, coordination, and execution of regulatory submission activities within the R&D team at Sanofi. The ideal candidate will have over 5 years of experience...Suggested
- Xenon Pharmaceuticals Inc. is seeking a Senior Manager for Regulatory Affairs Operations at its Needham, MA office. This role involves supporting global regulatory submissions through effective collaboration with cross-functional teams. Ideal candidates will have over...SuggestedWork at office
- Executive Director, Regulatory Operations and Submission Management The Executive Director, Regulatory Operations will provide strategic and operational leadership for global regulatory operations and systems, submission management and execution across the product portfolio...Suggested
$246.33k - $304.29k
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...Flexible hours$270k - $330k
...The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory... ...to R&D, Franchise, and Commercial Operations for assigned products and projects and... ...regulatory boards).Lead the preparation of submissions incl PIP, scientific advice, orphan...Temporary workLocal areaWorldwideFlexible hours- ...Therapeutics, Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The... ...the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold a BS/BA...
$270k - $330k
...Position Overview The Senior Director, Global Regulatory Affairs, Oncology is accountable for... ...between R&D, Franchise, and Commercial Operations and Global Regulatory Affairs on all regulatory... ...regulatory boards. Prepare and lead submissions such as PIP, scientific advice, orphan...Temporary workWorldwideFlexible hours$211.85k - $317.78k
...what you will do: The Senior Regulatory Affairs Director (Sr RAD), Global Regulatory Strategy, leads the development... ...early development through global submission and approval. May serve in a dual... ...in our offices 3 days a week. Our head office is purposely designed with...Hourly payTemporary workWork at officeFlexible hours3 days per week$245k - $300k
...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. Key...- ...Therapeutics is looking for a Director, Regulatory Affairs in Boston, Massachusetts. In this role, you will develop innovative global regulatory strategies for rare hematological... ...The position involves leading regulatory submissions and communicating with health authorities...
- JobRx, Inc. is looking for a Director of Global Regulatory Affairs specializing in Neuroscience. This role involves developing innovative... ...and negotiation skills are essential, as you will manage FDA submissions and collaborate with global teams to navigate the regulatory...
- ...Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic... ...regulatory strategies to support global product development, particularly in immunology... ..., and the ability to manage regulatory submissions and work with health authorities such as...
- Noema Pharma is seeking a Director of Regulatory Affairs to lead the development and commercialization of products in clinical programs. This senior role requires a candidate with strategic leadership skills and over 10 years of regulatory experience in the pharmaceutical...Local area
- ...Therapeutics in Cambridge, Massachusetts is looking for a Regulatory CMC Product Lead to independently develop and execute... ...CMC requirements. This role involves leading submissions, ensuring compliance with global regulations, and building relationships with internal...
- JobRx, Inc. is looking for a Director to define and lead global regulatory strategies in Boston, MA. The ideal candidate will manage the Global... ...with regulatory requirements, and oversee all FDA submissions. The role demands strong leadership, extensive experience in...
$212k - $333.19k
...Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you... ...stages. Provide strategic, operational and tactical regulatory... ...Regulatory Portfolio Lead and/or TA Head. May participate in or lead... .... Accountable for US FDA submissions and approvals of project(s)...Minimum wageTemporary workLocal areaWorldwide- ...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...
$137k - $215.27k
...changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...that enables the development of robust and accurate submissions. Develops constructive relationships with and proactively communicates...Full timeTemporary workLocal areaRemote workWorldwide- A leading global biopharmaceutical company is seeking a Director of Global Regulatory Affairs. This role is pivotal in developing innovative regulatory strategies for... ...include leading regulatory teams, managing FDA submissions, and ensuring compliance across multiple...
- Job Description Director Global Regulatory Affairs, Neuroscience responsible for developing innovative global regulatory strategies and providing... ...in cross‑functional initiatives, and manage U.S. FDA submissions and approvals. The Director also leads and manages direct reports...Local area
$177k - $278.08k
...life‑changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for developing... ...technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with... ...regulatory expectations. Lead the preparation, submission, and maintenance of regulatory applications, including...
- ...implementation, and oversight of the global PV compliance program to... ...with applicable global regulatory requirements, industry standards... ...cross-functionally with PV Operations, Clinical Safety, Regulatory... ..., and regulatory submission compliance, as applicable....Local area
- IPSEN is seeking a Senior Director, Global Regulatory Affairs, Oncology to provide regulatory strategic leadership and implement activities... ...regulatory strategy development, management of regulatory submissions, and fostering strong relationships with key stakeholders....
$238k - $374k
JobRx, Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership role requires over 20 years of industry experience, with significant expertise in regulatory submissions for medical devices and combination products. You will oversee...- A leading biopharmaceutical company is seeking a Director of Global Regulatory Strategy to lead strategies and ensure compliance with regulatory requirements. You will oversee FDA submissions, manage Global Regulatory Teams, and contribute to cross-functional projects....
$212k - $333.19k
...Senior Director, Global Regulatory Lead – Oncology At Takeda, we are a forward-looking, world... ...stages. Providing strategic, operational and tactical regulatory insight on one... ...leadership team. Accountable for US FDA submissions and approvals of project(s) of...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$137k - $165k
...Overview The Senior Manager, Global Trade Compliance – Export Compliance is a strategic leadership... ...and awareness programs, and ensure adherence to regulatory requirements across all jurisdictions in which the company operates. The role requires deep technical expertise,...Full timeTemporary workPart timeWork at officeLocal area
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