Senior Regulatory Affairs jobs in Irvine, CA

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GLOBAL REGULATORY AFFAIRS - SENIOR FINANCIAL ANALYST

Develop and maintain financial models to support strategic initiatives. Analyze financial data and reports to identify trends, issues, and opportunities. Prepare regular reporting to management for review. Collaborate with cross-f...

CompanyNorthern Trust
AddressChicago, IL
CategoryInformation Technology
SalaryUnspecified
Job typeFull time
Date Posted 13 hours ago See detail

Global Regulatory Affairs - Senior Financial Analyst New

Northern Trust

Chicago, IL

Unspecified

Develop and maintain financial models to support strategic initiatives. Analyze financial data and reports to identify trends, issues, and opportunities. Prepare regular reporting to management for review. Collaborate with cross-f...

Senior Manager, Regulatory Affairs Project Management and Strategic Planning

Biospace

Remote

You will lead cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late phase development programs by providing effective Project...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...

Executive Assistant, Regulatory Affairs New

Edwards Lifesciences

Irvine, CA

$69,000 - $94,000 a year

Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patients unmet clinical needs. Whether you are coordinating key meetings and events, su...

Senior Manager, Regulatory Affairs Vendor Governance

Biospace

California, United States

Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...

Senior Manager/Associate Director of Regulatory Affairs

Tempus

Chicago, IL

Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...

Senior Associate of Regulatory Affairs, CMC

Meitheal Pharmaceuticals Inc

Chicago, IL

Other duties may be assigned. Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying,...

Manager, Global Regulatory Affairs CMC Submissions Management

Biospace

Lexington, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in...

Senior Manager, Global Regulatory Labeling Strategy

Biospace

Remote

Leads Labeling cross-functional teams, facilitates discussions on labeling strategies and content for assigned product(s) and ensures cross-functional collaboration and alignment, for assigned product(s), with appropriate supervis...

Regulatory Affairs Specialist III

Boston Scientific

Maple Grove, MN

Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE...

Senior Director, Public Affairs

Biospace

Washington, United States

Develop and lead environment crafting communications campaigns and activities for priority policy goals with GPP, Legal, FGA, LVA and the BUCAs. Collaborate with partners within Global Corporate Communications, (Corporate Channe...

Senior Manager, Risk & Regulatory Advisory

Morgan Franklin

Texas, United States

Work with emerging growth companies and established enterprises (bothpubliclytraded and privately held) on a wide variety of projects including Sarbanes-Oxley ("SOX") readiness and compliance, internal audit, and ERM.. Assist...

Senior Regulatory Officer- Vice President

Morgan Stanley

Alpharetta, GA

Manage/prepare deliverables and responses based upon Bank regulators requests by identifying and working with subject matter experts across the Banks and Firm Manage internal preparation and working sessions to prepare and packag...

Manager, Global Regulatory Affairs CMC Submissions Management - Now Hiring

Takeda Pharmaceutical

New York, United States

$138,500 - $186,000 per year

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in...

Regulatory Affairs Specialist

Convatec

Lexington, MA

$49.4K - $62.5K a year

Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports Providing strategic product direction to teams on interaction and negotiating evidence with re...

Associate Director, Regulatory Affairs Innovation

Biospace

Irvine, CA

Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through...

Regulatory Affairs Associate - North Chicago, United States - Validation Associates

Validation Associates

United States

As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership...

Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite)

Avanos Medical

Alpharetta, GA

401(k)

Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;. Making a difference in how we work and collaborate, constantly nurturing our nimble culture of inn...

Sr. Specialist, Regulatory Affairs CMC

Biospace

United States

Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy. Review and edit final documents for regulatory...

Associate Director, Regulatory Affairs Advertising and Promotion

Biospace

California, United States

Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...

Regulatory Affairs Manager - Now Hiring

Abbott Laboratories

Texas, United States

$95000 - $190000 per year

Develops sound global regulatory strategies for new and modified medical devices. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Pr...

Seen - Senior Regulatory Counsel, Credit Card (...

A Digital-Finance Company

Chicago, IL

Seen Finance is seeking a talented and motivated Senior Regulatory Counsel to join our team. The Regulatory Counsel will play a crucial role in ensuring that our operations comply with all relevant laws, regulations, and industry...

Sr Regulatory Affairs Specialist

Johnson & Johnson

Irvine, CA

...

Manager, Regulatory Affairs

Invenergy

Chicago, IL

Monitor, coordinate and lead advocacy efforts at state economic and environmental regulatory bodies (public utility commissions, public service commissions, utility boards, state procurement entities, state EPA or siting authoriti...

Manager - Regulatory Affairs

Biospace

Lexington, MA

Compile, submit and maintain applications (IND, CTAs, NDAs etc.) to regulatory agencies in support of investigational and marketed products, including compiling and submitting responses to agency queries. Create and maintain produ...

Director, Digital Health Regulatory Affairs

Mcra

West Virginia, United States

Develop and execute regulatory services for client companies, including however not limited to:. Regulatory Submissions (510(k), IDE, PMA, De Novos, BLA, & IND). Regulatory Strategy, Analysis & Development. Design, Review & Implem...

Senior Data Analyst - Revenue and Regulatory

Hard Rock Digital

Remote

$89.7K - $114K a year

Recognize and diagnose potential errors or data inconsistencies between multiple reports. Investigate any irregularities with the finance and data engineering teams. Translate internal and external reporting needs into SQL queries...

Clinical Affairs Senior Manager Immunossays

Biomérieux

United States

A family-owned company, bioMrieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve publi...

Senior Director, Cellular Therapy Patient & Professional Relations, Public Affairs

Biospace

California, United States

Serve as a strategic business partner and advisor to Commercial and R&D teams, leveraging advocacy expertise, business acumen and interpersonal skills to bring the voice of the patient to Kite's planning and programming. Manage ke...