Regulatory Affairs Specialist jobs in Irvine, CA

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REGULATORY AFFAIRS SPECIALIST III

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...

CompanyBoston Scientific
AddressMaple Grove, MN
CategoryInformation Technology
Date Posted 3 weeks ago See detail

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...

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...

Sr Regulatory Affairs Specialist

Johnson & Johnson

Irvine, CA

...

Executive Assistant, Regulatory Affairs

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...

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...

Global Regulatory Affairs - Senior Financial Analyst

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...

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...

Regulatory Oversight Specialist

Northern Trust

Chicago, IL

Unspecified

Proactive oversight and maintenance of the enterprise Regulatory Change Framework, monitoring of the firms alignment with the RCF throughout the regulatory life cycle. Liaison with stakeholder groups across all lines of defense t...

Regulatory Specialist (In-Depth Recreational Marijuana Inspector) Portland

Oregon Liquor & Cannabis Commission

Oregon, United States

$4,993 - $7,641 a month

Conduct in-depth investigations on referrals from the METRC Team and management. Initiate appropriate compliance actions. Ensure persons and entities are appropriately licensed for activities which require a Recreational Marijuana...

Corporate Affairs Specialist II

Pinterest

Remote

$85.7K - $108K a year

Drive volunteer service initiatives globally across Pinterest, supporting broad participation in impactful service across the company. That includes initiating and managing large-scale service activities and campaigns, supporting...

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...

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...

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...

Entry Level Regulatory Specialist - Cincinnati, United States - Actalent

Actalent

United States

University / Bachelor's Degree in food, biological or physical sciences or relevant field. Hiring diverse talent. Maintaining an inclusive environment through persistent self-reflection. Building a culture of care, engagement, and...

Regulatory Specialist - Cumberland, United States - PPL Corporation

Ppl Corporation

United States

Develop process improvements to support the goals and objectives of the CCC, coach, counsel, and train employees as appropriate. Oversee reporting compliance for all DPUC reporting requirements. Provide reminders to submitters 30...

Regulatory Specialist II - Cincinnati, United States - Actalent

Actalent

United States

Actively participate in department meetings & discussions. Proactively participates in team building events & networking opportunities. Sensory Panel Participation. Virtual and In-Person Events. Advise internal customers regarding...

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...

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...

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...

Regulatory Specialist II - Cincinnati, United States - Actalent

Actalent

United States

Actively participate in department meetings & discussions. Proactively participates in team building events & networking opportunities. Sensory Panel Participation. Virtual and In-Person Events. Others as the business dictates. Ad...

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 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,...

Regulatory Specialist - Cincinnati, United States - Actalent

Actalent

United States

University / Bachelor's Degree in food, biological or physical sciences or relevant field. Hiring diverse talent. Maintaining an inclusive environment through persistent self-reflection. Building a culture of care, engagement, and...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...