828 Results for

CT Technologist Jobs in Cambridge, MA

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Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810 GRAIL

Sunnyvale, CA

$189,000–$271,000 / year

The Director serves as a senior regulatory subject-matter expert and strategic business partner, who leads cross-functional teams in developing promotional materials to ensure compliance with global regulatory markets, while capturing potential regulatory risks. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

30+ days ago

Associate Director Regulatory Affairs Advertising & Promotion - Oncology AbbVie Inc

South San Francisco, CA

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

7 days ago

BridgeBio-- Regulatory Affairs Postdoctoral Research Fellow Northeastern University

San Jose, CA

$66,345–$93,712.50 / year

Develop and maintain knowledge of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and other relevant global guidelines to ensure compliance of regulatory strategies and submissions. Support regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, health authority regulations, ICH guidelines, Pharmaceutical Research & Manufacturers of Americans (PhRMA) guidelines, company policies and established precedents and recommend revisions/actions that achieve fair balance.

10 days ago

Vice President, Regulatory Affairs Insitro

South San Francisco, CA

$313,000–$333,000 / year

Reporting directly to the Chief Medical Officer, you will develop and implement global regulatory strategies supporting multiple therapeutics - small molecules, biologics, and oligonucleotides - and diagnostics across our three therapeutic areas: neurology/neurodegeneration, metabolism/cardiovascular, and ophthalmology. You will be at the forefront of implementing and influencing new regulatory policy across multiple jurisdictions using objective, data-driven approaches, treating health authorities as key partners who share our vision of bringing better, more targeted drugs to patients faster.

30+ days ago

Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) Nurix Therapeutics, Inc.

Brisbane, CA

$187,800–$208,600 / year

Author, review, and compile high-quality CMC (Module 3 / Quality) content for regulatory submissions, including IND/IMPD and equivalent global filings, amendments, annual reports, and responses to health authority questions. You'll combine hands-on authoring of Module 3 (Quality) content with real strategic influence as the CMC regulatory voice on cross-functional teams, with room at the Associate Director level to own strategy and mentor junior regulatory staff.

2 days ago

Manager, Regulatory Affairs Adicet Bio, Inc.

Redwood City, CA

They will be primarily responsible for managing the global CMC regulatory implementation of assigned projects in early to late-stage development, with additional responsibility to support the implementation of other regulatory activities, including clinical and nonclinical submissions. Assist senior RA staff in the development of Meeting Requests, Briefing Books and meeting materials for FDA and ex-US regulatory agency meetings, including pre-IND meetings, End of Phase meetings, Scientific Advice, etc.

30+ days ago

Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998 Ascendis Pharma

Palo Alto, CA

$215,000–$240,000 / year

Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations. Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs?

19 days ago

Director, Regulatory Affairs Nova Pneuma, Inc.

Fremont, CA

Part time

Manage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.

2 days ago

Senior Director, Regulatory Affairs Orca Bio

Menlo Park, CA

Essential Duties & Key Responsibilities: Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the C-Suite, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements — with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves.

30+ days ago

Senior Regulatory Affairs Specialist Varian Medical Systems Inc

$115,980–$159,478 / year

It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". Under the direction of Regulatory Affairs Management, this role independently leads regulatory assessments, develops strategy options, recommends compliant pathways, and advises leadership on regulatory risks, pathway options, and recommended approaches to support informed decision-making.

23 days ago

Sr. Regulatory Affairs Specialist Varian Medical Systems Inc

$115,980–$159,478 / year

23 days ago

Summer 2027 Internship - Regulatory Affairs - California Stryker

Fremont, California

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. As a Regulatory Affairs (RA) intern at Stryker, you will gain exposure to global regulatory strategy and compliance while working cross-functionally with teams such as R&D, Supplier Quality, Marketing, and Clinical Affairs.

30+ days ago

Senior Director, Regulatory Affairs Lead Orca Biosystems Inc

Menlo Park, CA

$250,000–$300,000 / year

Essential Duties & Key Responsibilities: Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the CMO, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements - with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves.

30+ days ago

Principal Regulatory Affairs Intuitive Surgical

Sunnyvale, CA

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

30+ days ago

Director, Regulatory Affairs California Life Company

South San Francisco, CA

$275,000–$280,000 / year

Position Responsibilities: Accountable to develop and execute the world-wide regulatory strategy for assigned programs (from IND-enabling to clinical proof-of-concept and beyond), which may include programs that are first-in-class, where no or limited FDA guidance exists, that have an external business partner, and where there are multiple indications. Calico's highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

30+ days ago

Senior Program Director, Commercial Regulatory Affairs Compass Consulting

South San Francisco, CA

Quick Apply

Program Directors in CORA chair Program Review Committees (PRCs) for their assigned responsibilities, e.g., products within a designated therapeutic area(s) or cross-portfolio activities, such as managed care, interactive marketing, etc. Program Directors lead and manage the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion regulatory review and approval for Roche pharmaceutical products.

13 days ago

Senior Regulatory Affairs Specialist Intuitive Surgical Inc

Sunnyvale, CA

30+ days ago

Senior Program Director (Commercial Regulatory Affairs, Fully Remote) Dawar Consulting

South San Francisco, California

Remote

You will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. Our client, a world leader in biotechnology and life sciences, is seeking a " Senior Program Director, Commercial Regulatory Affairs ".

30+ days ago

Senior Director, Regulatory Affairs CMC Mirum Pharmaceuticals Inc

Foster City, CA

$280,000–$310,000 / year

The Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. Actively seeks out knowledge of overall corporate planning, business objectives, and current regulatory requirements to develop regulatory positions for assets in Mirum portfolio, and incorporates this knowledge into submission planning.

30+ days ago

Manager, Regulatory Affairs Adicet Bio

Redwood City, California

$130,000–$179,000 / year

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms. They will be primarily responsible for managing the global CMC regulatory implementation of assigned projects in early to late-stage development, with additional responsibility to support the implementation of other regulatory activities, including clinical and nonclinical submissions.

30+ days ago

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CT Technologist Jobs in Cambridge, MA

Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810 GRAIL

Associate Director Regulatory Affairs Advertising & Promotion - Oncology AbbVie Inc

BridgeBio-- Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Vice President, Regulatory Affairs Insitro

Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) Nurix Therapeutics, Inc.

Manager, Regulatory Affairs Adicet Bio, Inc.

Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998 Ascendis Pharma

Director, Regulatory Affairs Nova Pneuma, Inc.

Senior Director, Regulatory Affairs Orca Bio

Senior Regulatory Affairs Specialist Varian Medical Systems Inc

Sr. Regulatory Affairs Specialist Varian Medical Systems Inc

Summer 2027 Internship - Regulatory Affairs - California Stryker

Senior Director, Regulatory Affairs Lead Orca Biosystems Inc

Principal Regulatory Affairs Intuitive Surgical

Director, Regulatory Affairs California Life Company

Senior Program Director, Commercial Regulatory Affairs Compass Consulting

Senior Regulatory Affairs Specialist Intuitive Surgical Inc

Senior Program Director (Commercial Regulatory Affairs, Fully Remote) Dawar Consulting

Senior Director, Regulatory Affairs CMC Mirum Pharmaceuticals Inc

Manager, Regulatory Affairs Adicet Bio

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