1,234 Results for

Operator Jobs in Round Lake, IN

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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

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

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

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

Manager, Regulatory Affairs Adicet Bio

Redwood City, California

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

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

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

VP Quality & Regulatory Affairs Nova Pneuma Inc

Fremont, CA

Provide executive oversight of Quality Assurance activities, including but not limited to: Quality Systems, Document Control, Training, Change Control, Deviations, CAPA (including timely implementation and closure), Audits (internal, external and supplier), Risk Management, and Product Release. As a member of the executive leadership team, the VP, Quality & Regulatory Affairs fosters a culture of quality, continuous improvement, operational excellence, patient focus, accountability, and cross-functional collaboration to support the companys strategic objectives.

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

Vice President, Regulatory Affairs Sight Sciences Inc

Menlo Park, CA

Proven leadership in compliance with an ability to troubleshoot within FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance, and medical device reporting. He or she should know regulatory road maps for medical devices and preferably combination drug-device products, which will speed up the clinical trial cycle, the regulatory process and garner more government resources.

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

Counsel, Global Regulatory Affairs Visa Inc

San Francisco, CA

$203,800–$326,100 / year

The Counsel must have excellent judgment and strong analytical, problem solving and client counselling skills; exceptionally strong communication skills (written and verbal); demonstrate strong attention to detail and resourcefulness; be self-motivated, entrepreneurial and a self-starter; be comfortable with using emerging technologies and Artificial Intelligence tools to create innovative and efficient ways to work; be a confident, creative, forward-thinking, and collaborative team player; and be skilled at managing multiple priorities in a fast-paced, time-sensitive, and challenging, but highly rewarding, environment. The Associate Counsel will join a dynamic legal team, and work closely with experienced lawyers across the globe and different practice groups to support and advise internal Visa teams, develop the company's thought leadership and strategy in key regulatory areas, and draft regulatory submissions and responses to government requests and public consultations.

30+ days ago

Senior Regulatory Affairs Labeling Specialist PROCEPT BioRobotics Corporation

San Jose, California

Represent the Regulatory Affairs labeling function on project teams by collecting potential labeling inputs from other departments; interpreting the impact that projects, such as design changes, will have on labeling content; and implementing necessary modifications to the product labeling. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

19 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

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

Senior Manager, Regulatory Affairs Labeling Mirum Pharmaceuticals Inc

Foster City, CA

$175,000–$195,000 / year

The Senior Manager (SM), Regulatory Affairs Labeling will play a key role in providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed products. Create and update labeling content for assigned programs of marketed product(s) and development products in US and international regions including: CCDS, prescribing information, medication guides, patient information/leaflet/IFU, package label artwork.

30+ days ago

Senior Regulatory Affairs Specialist (4033938 ) Selectek, Inc.

Santa Clara, CA

Quick Apply

Our client is seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory activities for new and existing products within its diagnostics, life sciences, and laboratory solutions portfolio. This individual will play a critical role in developing regulatory strategies, preparing regulatory submissions, ensuring ongoing compliance with global regulations, and partnering with cross-functional teams throughout the product lifecycle.

13 days ago

Senior Regulatory Affairs Labeling Specialist Procept Biorobotics Corp

San Jose, CA

$121,890–$143,400 / year

18 days ago

Senior Regulatory Affairs Manager - Digital Solutions (on-site) Abbott Laboratories

Santa Clara, CA

$130,700–$261,300 / year

Supporting pre-market and post-market cross functional teams; developing and communicating global regulatory strategies for new product submissions or complex changes to on-market products. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

30+ days ago

Senior Director, Regulatory Affairs Septerna

South San Francisco, CA

$270,000–$295,000 / year

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission.

26 days ago

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Operator Jobs in Round Lake, IN

Senior Director, Regulatory Affairs Orca Bio

Manager, Regulatory Affairs Adicet Bio, Inc.

Senior Director, Regulatory Affairs Lead Orca Biosystems Inc

Summer 2027 Internship - Regulatory Affairs - California Stryker

Manager, Regulatory Affairs Adicet Bio

Senior Program Director, Commercial Regulatory Affairs Compass Consulting

Director, Regulatory Affairs California Life Company

VP Quality & Regulatory Affairs Nova Pneuma Inc

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

Vice President, Regulatory Affairs Sight Sciences Inc

Senior Director, Regulatory Affairs CMC Mirum Pharmaceuticals Inc

Counsel, Global Regulatory Affairs Visa Inc

Senior Regulatory Affairs Labeling Specialist PROCEPT BioRobotics Corporation

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

Principal Regulatory Affairs Intuitive Surgical

Senior Manager, Regulatory Affairs Labeling Mirum Pharmaceuticals Inc

Senior Regulatory Affairs Specialist (4033938 ) Selectek, Inc.

Senior Regulatory Affairs Labeling Specialist Procept Biorobotics Corp

Senior Regulatory Affairs Manager - Digital Solutions (on-site) Abbott Laboratories

Senior Director, Regulatory Affairs Septerna

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