Senior Regulatory Leader, Diagnostics & NDA/PMA
Foundation Medicine Inc
Foundation Medicine is seeking an Associate Director, Regulatory Affairs in Boston to lead regulatory strategy and manage FDA submissions for diagnostic assays. You will guide complex projects, collaborate with product development and biopharma partners, and mentor a small team of regulatory professionals.
The role requires significant regulatory affairs experience, strong leadership, and the ability to interface with regulators and cross-functional teams to ensure compliant product development
#J-18808-LjbffrVacancy posted 11 hours ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Leader, Diagnostics & NDA/PMA in Boston, MA vacancy
- A pioneering biotechnology company seeks a Senior Scientist to lead the development of in vitro diagnostic products. This role involves managing research projects, ensuring compliance with regulatory standards, and mentoring junior staff. Candidates should hold a PhD in...SeniorRegulatoryWorldwide
- Philips is seeking a Head of Regulatory for Ambulatory Monitoring & Diagnostics to lead global regulatory strategy, ensuring compliance across development and... ...medical devices, strong leadership, and the ability to influence senior stakeholders. #J-18808-Ljbffr PhilipsRegulatory
$229.56k - $344.35k
...visionary and strategic Program Leader to serve as the single point... ...clinical development through regulatory approval, global launch, and lifecycle... ...comfortable engaging with Senior Leadership and rolling up your... ...with and understanding of NDA/BLA or equivalent submissions...SeniorRegulatoryTemporary workWork at officeFlexible hours3 days per weekAgios Pharmaceuticals
Cambridge, MA11 hours ago- ...IBM Promontory Australia is seeking a Senior Principal Consultant to lead regulatory and risk management engagements for financial services clients. You will define strategic solutions, guide conduct risk programs, and drive high-quality deliverables while building lasting...SeniorRegulatory
IBM
Boston, MA11 hours ago - ...Alexion Pharma Spain S.L. in Boston seeks a Senior Medical Director, Clinical Development Neurology to lead the clinical development... ...assets across multiple programs, from IND/CTA through Phase 3 and regulatory submission. The role requires an MD/DO/MBBS, 7+ years in...SeniorRegulatory
- ...BNY Mellon seeks a Senior Vice President of Regulatory Reporting in Boston, MA to lead multiple teams responsible for preparing and reviewing regulatory filings for clients and their funds. You will establish processes to ensure completeness and accuracy, resolve escalations...SeniorRegulatory
BNY Mellon
Boston, MA10 hours ago - ...operational excellence and providing clinical feasibility insights. This hybrid position is located at Alnylam's Cambridge, MA headquarters. Candidates should have significant drug development experience and a strong background in regulatory interactions. #J-18808-Ljbffr...SeniorRegulatory
Alnylam Pharmaceuticals
Cambridge, MA11 hours ago - Novartis is seeking a Senior Principal Scientist or Associate Director to lead imaging efforts in drug development, spanning oncology... ...functional teams, advance novel imaging approaches, and contribute to regulatory interactions while leveraging a broad translational portfolio...SeniorRegulatory
$212k - $333.19k
...a lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...on time with high quality, including major submissions (NDA/BLA/MAA)For the project(s) of responsibility, collaborate...SeniorRegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide- ...seeks an Associate General Counsel who will be a key member of the Senior Leadership Team, providing strategic legal advice. The role... ...oversee privacy compliance, intellectual property management, and regulatory strategies, contributing to the company's growth and...SeniorRegulatory
- ...Bank Corporation in Boston is seeking an experienced Commercial Senior Relationship Manager for Government Banking. You will manage a... ...products, and staying current with market trends to grow business while maintaining regulatory compliance. #J-18808-Ljbffr M&T Bank CorporationSeniorRegulatory
- Moderna Therapeutics in Cambridge, MA is seeking an Associate Director of Regulatory Data Management & Intelligence to define data strategy, governance, and the digital data ecosystem within Regulatory Information Management. You will own Veeva Vault RIM data capabilities...SeniorRegulatory
- ...retail pharmacy operations. The role focuses on monitoring, due diligence, and reporting, coordinating with Pharmacy Ops, Legal, and Regulatory Affairs to ensure adherence to state and federal regulations. The position supports flexible/hybrid work with 3 in-person days at...SeniorRegulatoryRemote workFlexible hours
- ...A leading digital health company is seeking a Senior Manager, Data Governance to lead their data governance program. In this role, you... ...a culture of data stewardship and ensure compliance with regulatory standards. This position offers hybrid work flexibility.#J-1880...SeniorRegulatoryRemote work
PatientPoint®
Boston, MA11 hours ago - Xenon Pharmaceuticals wants a Senior Manager/Associate Director of Marketing Operations & Commercial Review to lead the CRC/MLR process... ..., and high-quality delivery of programs across Marketing, Regulatory, Legal, Medical, and Compliance. Based in Boston/Needham, MA with...SeniorRegulatory
- Nestlé Health Science is seeking a Senior Specialist in Regulatory & Scientific Affairs (RSA) to lead regulatory compliance activities for the US market. You will guide cross-functional teams on recipe compliance, labeling, claims substantiation, ingredient qualification...SeniorRegulatory
- Vertex Pharmaceuticals seeks an Operational Area Quality Senior Manager to provide quality leadership for assembly manufacturing of medical... ...quality activities across processes, with a focus on continuous improvement and regulatory #J-18808-Ljbffr Vertex PharmaceuticalsSeniorRegulatory
- Synapse Energy Economics, a leader in energy consulting, is looking for a Principal Associate based in Cambridge, MA. The ideal candidate will lead innovative regulatory analyses and work on projects to develop customer protections and rate designs for distributed energy...SeniorRegulatoryFlexible hours
- ...investigative sites to advance patient care. The role combines scientific exchange, KOL engagement, and strategic leadership of MSLs, requiring cross‑functional collaboration, proactive planning, and strict regulatory compliance across study sites and teams. #J-18808-LjbffrSeniorRegulatory
Syneos Health Commercial Solutions
Boston, MA10 hours ago - Bausch Health Companies Inc. is seeking a Senior Director of Advertising & Promotion - Regulatory Affairs to lead and participate in reviews of promotional labeling for prescription, OTC, and cosmetics in the US, with support for Canada. The role ensures materials comply...SeniorRegulatory
- ...operations for internal manufacturing. This role includes oversight of technical activities, continuous improvement, and compliance with regulatory standards. The successful candidate will play a critical role in driving quality excellence across manufacturing while building...SeniorRegulatory
- ...and major lifecycle events, leading early launch activities with robust supply, quality, regulatory, and flow-of-goods strategies. You will partner with Asset Leaders and senior stakeholders to align commercial ambition, supply feasibility, and financial outcomes, identifying...SeniorRegulatory
- ...provide technical leadership and statistical support, while collaborating across teams to ensure successful clinical study designs and regulatory submissions. The ideal candidate holds a PhD in statistics with extensive experience in clinical trials, capable of communicating...SeniorRegulatory
$248k - $397k
Role: Global Financial Services, Senior Director, Banking LeaderWho You AreYou are an accomplished Banking industry leader with deep experience across retail banking, commercial... ...you understand the business, technology, regulatory, and competitive forces shaping the...SeniorRegulatoryTemporary workLocal area- Apex Companies, LLC is seeking a Senior Hydrogeologist for our Northeast Division in a hybrid role. You will lead hydrogeologic analyses, manage teams, and deliver groundwater modeling and regulatory support across New England. The position emphasizes project leadership...SeniorRegulatory
$212k - $333.19k
...will inspire you and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge office.At... ...enterprise leadersCommitted to simultaneously driving regulatory approval as well as launch and global patient accessAbility...SeniorRegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workNight shift- ...partners with CTOs and internal teams to manage deviations, change controls, investigations, CAPAs, and the stability program, ensuring cGMP compliance and regulatory readiness across ICH, FDA and EMA guidelines, with opportunities for #J-18808-Ljbffr Genetix BiotherapeuticsSeniorRegulatory
- ...coordinate daily SNF clinical operations. You will lead day-shift nursing, oversee admissions, implement physician orders, and ensure regulatory compliance while collaborating with interdisciplinary teams and families. The role requires strong leadership, 5+ years nursing...SeniorRegulatoryDay shift
- Amylyx Pharmaceuticals is seeking a Senior Vice President of Clinical Development to provide strategic leadership for clinical programs... ...overseeing clinical trial design and execution while managing regulatory affairs and budget strategies. The ideal candidate should have...SeniorRegulatoryRemote job
$196k - $279k
...and highly skilled Senior/Executive Director... ...Medicine leader to build a cutting... ...milestones from pre-IND to NDA. The successful... ...criteria and companion diagnostics, demonstration of... ...to IND, NDA, PMA submissions via authoring... ..., business, and regulatory approaches You...SeniorRegulatoryContract work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Leader, Diagnostics & NDA/PMA. Be the first to apply!
Related searches
- member team lead Boston, MA
- team leader production Boston, MA
- site leader Boston, MA
- team leader training Boston, MA
- team lead data science Boston, MA
- group strategy director Boston, MA
- team leader day shift Boston, MA
- market leader Boston, MA
- compliance team leader Boston, MA
- after school program leader Boston, MA