Senior Vice President, Global Regulatory Affairs
Confidential
Senior Vice President, Global Regulatory Affairs
About the Company
Clinical-stage biotechnology company pioneering next-generation precision oncology therapeutics and accelerated global registration.
Industry
Biotechnology
Type
Privately Held, VC-backed
About the Role
The Company is in search of a Senior Vice President for Global Regulatory Affairs to lead the regulatory vision for its innovative oncology pipeline. The successful candidate will be the senior-most regulatory leader, responsible for developing and driving global regulatory strategy from early development to post-marketing planning. This role demands a hands-on regulatory innovator with a proven track record in global oncology regulatory strategies, particularly in the context of accelerated and expedited pathways. The SVP will oversee all interactions with global health authorities, guide registration pathways for therapeutics and associated enabling technologies, and ensure the infrastructure is in place for eventual commercialization. Collaboration with cross-functional teams, including translational sciences, clinical development, and external partners, is essential, as is the ability to mentor and build a high-performing global regulatory team. Applicants must have a minimum of 15 years of regulatory experience in the biopharmaceutical industry, with a focus on global oncology. Extensive expertise in oncology regulatory affairs, particularly in the context of late-stage development, is a prerequisite. The ideal candidate will have a successful history with accelerated and expedited regulatory programs, including those with the FDA and EMA. Experience in leading regulatory strategy for programs involving novel biomarkers, diagnostics, or patient-selection tools is a plus. The role requires exceptional communication skills, scientific fluency, and the ability to translate complex data into regulatory strategy. The SVP will also be responsible for establishing and maintaining regulatory systems, processes, and documentation standards, as well as ensuring inspection readiness and compliance as the organization progresses toward pivotal trials.
Travel Percent
Less than 10%
Functions
- Business Development
$110k - $225k
...FleishmanHillard has an immediate opening for a Senior Vice President to join our TRUE Global Intelligence (TGI) practice... ...areas, business models, and regulatory environment. They must have a... ...relations, reputation management, public affairs, brand marketing, digital strategy...SeniorWork at officeLocal areaImmediate startFleishmanHillard
Boston, MA8 days ago- ...Deputy Chief Development Officer & Senior Vice President, Global Development About the Company Dynamic organization addressing climate change & pollution issues Industry Non-Profit Organization Management Type Non Profit Founded 1967 Employees...SeniorShift work
- ...Senior Vice President, Compliance And Control We're seeking a future team member for the role... ...controls, and monitoring processes meet all regulatory requirements. In this role, you'll... .... We provide access to flexible global resources and tools for your life's journey...SeniorFlexible hours
BNY
Boston, MA1 day ago - STATE STREET CORPORATION in Boston is seeking a Vice President to lead the Tax Center of Excellence. The role involves overseeing global tax compliance for investment products and requires significant custody tax and/or tax advisory experience. The ideal candidate will...SeniorWork at office
$225k - $337.5k
STATE STREET CORPORATION is seeking a leader to manage global delivery of Middle Office product implementations for Alpha. This role involves shaping operational models, leading regional teams, and ensuring high service quality while managing risks and meeting contractual...SeniorWork at office$225k - $275k
The Blackstone Group L.P. is seeking a Senior Vice President Attorney for the Private Wealth Public Funds Legal Group in San Francisco. This role involves overseeing legal matters for BREIT, including preparing public offering materials, managing corporate governance, and...SeniorFull time$310k - $325k
Senior Vice President, Project & Program Management Job Description This Opportunity Join our growing Program Management Team that meets our... ...Protected Veteran Status. The selected candidate must be authorized to work in the United States. #J-18808-Ljbffr WSP Global Inc.SeniorFor subcontractorWork at officeLocal area- Initial Therapeutics, Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product...Senior
- ...Venus Aesthetic Intelligence is seeking a Vice President, Regulatory Affairs, Quality Assurance & Quality Control. This strategic leader will oversee... ...within the organization, drive improvements, and manage global regulatory strategy. Candidates must have a minimum of 10...
Venus Aesthetic Intelligence
Boston, MA3 days ago - ...Vice President, Global Quality Compliance About the Company Well-known pharmaceutical company Industry Pharmaceuticals Type... ...candidate will be responsible for providing enterprise-wide regulatory compliance oversight, with a focus on global GMP compliance...
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...SeniorRemote job
$102k - $220k
...Senior Vice President, Regulatory Administration/ Filings Manager At BNY, our culture allows us to run our company better and enables employees' growth and success. As a leading global financial services company at the heart of the global financial system, we influence...SeniorTemporary workWork experience placementWork at officeWorldwideFlexible hoursBNY
Boston, MA1 day ago$137k - $215.27k
Initial Therapeutics, Inc. is looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device experience and a BS/BA degree in a scientific discipline. Responsibilities include executing regulatory...Senior- ...clinical‑stage biotechnology company pioneering next‑generation precision oncology therapeutics is seeking a Vice President/Senior Vice President Global Regulatory Affairs. Their approach is integrating cutting‑edge translational science, advanced patient‑selection...
$208.2k - $327.14k
...Senior Director, Global Regulatory Lead – Oncology Base pay range: $208,200.00/yr - $327,140.00/yr Location: Boston, MA About the role... ...such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively...SeniorLocal areaRemote workWorldwideTakeda
Boston, MA4 days ago- ...Senior Vice President, Enterprise Sales and Payments About the Company Internationally renowned payments technology company Industry... ...experience, a proven track record in selling to large national or global retailers, and a strong background in POS, payments, retail...Senior
- ...We're seeking a future team member for the role of Senior Vice President, Compliance and Control to join our BNY Investments team. This role... ...ensure policies, controls, and monitoring processes meet all regulatory requirements. In this role, you'll make an impact in...Senior
BNY Mellon
Boston, MA1 day ago - ...Senior Vice President, Retail Excellence About the Company Globally renowned luxury lifestyle brand Industry Luxury Goods & Jewelry Type Privately Held About the Role The Company is seeking a Global SVP for Retail Excellence to define and lead the...SeniorWorldwide
- ...Senior Vice President of Sales About the Company Private equity-backed technology company focused on risk management and compliance within... ...team to drive the company's expansion both in the U.S. and globally. Hiring Manager Title President of U.S. & Global...SeniorFor contractors
- ...Senior Vice President, Quality Operations (OSD) About the Company Internationally renowned pharmaceutical company Industry Pharmaceuticals... ...pivotal in acting as the principal strategic interface with global health authorities, ensuring compliance, and driving the...Senior
- ...hr Summary of Position: The Senior Manager, Pharmacovigilance (PV... ..., and oversight of the global PV compliance program to ensure... ...adherence with applicable global regulatory requirements, industry... ...Clinical Safety, Regulatory Affairs, Quality Assurance, and external...SeniorLocal area
- ...Senior Vice President, Client Services About the Company A leading global medical communications agency expanding its US leadership team. Industry Public Relations... ...shaping the company's commercial and medical affairs strategy on a global scale. The successful...Senior
$137k - $215.27k
...boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of...SeniorMinimum wageFull timeTemporary workLocal areaRemote workWorldwideTakeda Pharmaceutical Company Ltd
Boston, MA2 days ago- ...therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership... ...principles. Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health...Remote workWorldwide
Takeda
Cambridge, MA4 days ago $160k - $200k
...Job Description Job Description Senior Vice President (SVP), Public Relations Boston, MA (Hybrid: 2–3 days in office) Full-time... ...0 Best Agencies in the U.S. A Top 40 Technology Agency globally One of the 20 Best U.S. Agencies to Work For Our culture...SeniorFull timeWork at officeTier One Partners, LLC
Boston, MA3 days ago- ...Senior Vice President, Media Investment (Pharma) Digitas is the Networked Experience Agency, built on the vision that we create magnetic experiences... ..., Digitas serves the world's leading brands through a global network comprised of more than 5,500 employees across over 6...SeniorShift work
Prodigious Worldwide
Boston, MA1 day ago - ...Senior Vice President, Data and Analysis Digitas is the Networked Experience Agency, built on the vision that we create magnetic experiences... ..., Digitas serves the world's leading brands through a global network comprised of more than 5,500 employees across over 6...SeniorWork experience placement
Prodigious Worldwide
Boston, MA3 days ago $110k - $177.5k
The Vice President, Communication Surveillance Compliance is a leadership role responsible for... ..., and oversight of State Street’s global communication surveillance program. This... ...compliance with internal conduct standards and regulatory expectations. The incumbent serves as...Temporary workWork at officeRemote workWork from homeFlexible hours$180.22k - $286.83k
...Gartner, Digitas serves the world’s leading brands through a global network comprised of more than 5,500 employees across over 6... ...of all kinds. Overview We’re searching for a Senior Vice President, Media who’s a true unicorn to join the team at Digitas. Someone...SeniorFlexible hoursDigitas
Boston, MA3 days ago$171k - $235k
...Weber Shandwick is more than a leading global PR agency - we're an engagement agency... ...to build brands and reputations. Senior Vice President, Social & Influencer Strategy - Healthcare... ...navigating the nuances of healthcare, regulatory considerations, and risk mitigation....SeniorCirca - IPG DXTRA
Boston, MA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Vice President, Global Regulatory Affairs. Be the first to apply!
- vp account director Boston, MA
- vice president of application development Boston, MA
- vice president digital media Boston, MA
- vice president technical operations Boston, MA
- vice president internal communications Boston, MA
- vice president data analytics Boston, MA
- vp internal audit Boston, MA
- vice president corporate communications Boston, MA
- vice president of product strategy Boston, MA
- vice president of retail Boston, MA