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REGULATORY AFFAIRS PROJECT MANAGER

Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate. Maintain up-to-date knowledge on domestic and international regulatory re...

CompanyEndologix
AddressIrvine, CA
CategoryInformation Technology
Salary$104,000 - $165,000 a year
Job typeFull-time
Date Posted 4 weeks ago See detail

Regulatory Affairs Project Manager

Endologix

Irvine, CA

$104,000 - $165,000 a year

Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate. Maintain up-to-date knowledge on domestic and international regulatory re...

4 weeks ago seen See more...

Regulatory Project Management Consultant (Part-Time Contract)

Biospace

Menlo Park, CA

Coordinate and review regulatory submissions for global and US markets, including INDs and CTAs, and annual reports, in collaboration with regulatory lead and cross-functional teams. Develop and maintain regulatory documents, such...

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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...

2 days ago seen See more...

Project Manager-Regulatory

Ulteig

Rancho Cordova, CA

Provide project management support for large and complex projects. Support client with understanding of CA budget process and associated legislation. Virtually attend legislative hearings and provide briefings on relevant content....

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Sr. Project-Program Manager, Regulatory Affairs

Arthrex

Naples, FL

Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs.. Develops project objectives by reviewing project proposals and business plans, conferring with senior management and key stakeholde...

3 weeks ago seen See more...

Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience

Biospace

Remote

As Associate Director, Global Regulatory Project Management and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and...

4 days ago seen See more...

Manager, Global Regulatory Affairs CMC Submissions Management

Takeda Pharmaceutical

Bronx, NY

$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...

2 days ago seen See more...

Manager, Regulatory Affairs - Regulatory Project Manager

Daiichi Sankyo, Inc.

Basking Ridge, NJ

$117K - $148K a year

Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background M...

a month ago seen See more...

Director Regulatory Affairs - Submission Management - West Chester, PA

Teva Pharmaceuticals

West Chester, PA

Responsible to manage Product Submission Team and dossier timelines. Accountable to Global Regulatory Lead and Global Regulatory Affairs, with matrixed accountability to Project Management. Regularly reports to management on progr...

5 days ago seen See more...

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...

6 days ago seen See more...

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...

6 days ago seen See more...

Manager - Regulatory Affairs - Therapeutic Area

Biospace

Plainsboro, NJ

Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...

a week ago seen See more...

Counsel Senior Manager - Legal Entity Governance: Public, Regulatory and Corporate Affairs

Wells Fargo

Charlotte, NC

Work on matters for the subsidiaries of Wells Fargo & Company, including support for all aspects of Legal Entity corporate governance, planning and preparing for board and committee meetings, overseeing board evaluations for subsi...

6 days ago seen See more...

Manager Global CMC Regulatory Affairs

Johnson & Johnson

Titusville, NJ

Develops and realize global regulatory strategies for development compounds and marketed products according to scientific and risk-based principles. Participates as regulatory lead on CMC/VCM teams and represents CMC RA by provid...

a week ago seen See more...

Manager, Regulatory Affairs - Biosense Webster, Inc.

Johnson & Johnson

Irvine, CA

...

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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...

a week ago seen See more...

Senior Director, Global Regulatory Project Management, GI ²

Pix11

New York, NY

Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure Global Regulatory Project plans for programs/products of high complexity are established and maintained, and plans & directs the seamless e...

2 weeks ago seen See more...

Senior Director, Global Regulatory Project Management, GI ²

Takeda Pharmaceutical

Brooklyn, NY

Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure Global Regulatory Project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless...

2 weeks ago seen See more...

Senior Director, Global Regulatory Project Management, GI ²

Takeda Pharmaceutical

Bronx, NY

Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure Global Regulatory Project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless...

2 weeks ago seen See more...

Senior Manager, Regulatory Affairs - Proliant Health & Biologicals

Lauridsen Group, Inc.

Ankeny, IA

Professional conduct with high attention to detail. Strong verbal and written communication skills. Ability to work collaboratively and coordinate with team members. Competence in multitasking and organizational methods. Self-star...

a week ago seen See more...

Senior Manager Regional Regulatory Affairs

Biospace

King Of Prussia, PA

You will be the primary CSL representative to regional health authorities for assigned products.. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with resp...

2 weeks ago seen See more...

Regulatory Affairs Senior Program Manager

Biospace

San Francisco, CA

6+ years of Regulatory Affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products...

2 weeks ago seen See more...

Manager, Regulatory Affairs CMC

Pix11

New York, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

2 weeks ago seen See more...

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Bronx, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

2 weeks ago seen See more...

Manager, Regulatory Affairs CMC

Biospace

Boston, 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 in Cambridge, MA with the...

2 weeks ago seen See more...

Regulatory Affairs Manager Regional Regulatory Lead

Biospace

Washington, DC

Implement the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US. Provide content for and coordinate US regulatory documents and meetings in accordance with GRT s...

3 weeks ago seen See more...

Sr. Manager of Regulatory Affairs/ In-House Counsel at Software Company

Alchemy Legal

Los Angeles, CA

Lead and manage collections efforts, including developing strategies, negotiating settlements, and overseeing litigation processes. Handle litigation matters, including case management, legal research, and representation in legal...

3 weeks ago seen See more...

Regulatory Affairs Manager

Freudenberg Group

Remote

$94.6K - $120K a year

Provide regulatory excellence to the organization and guide decision making Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Establish project priorities, ensure resources are available and b...

3 weeks ago seen See more...

Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC

Boston Scientific

Saint Paul, MN

Oversite management of Core CRMRegulatory AffairsSustaining Program activities, with an emphasis on Leads and Lead accessories product portfolio. Manage a 3-4 person submissions team within a matrixed organization. Lead the CRM...

3 weeks ago seen See more...

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Brooklyn, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

3 weeks ago seen See more...

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The top companies hiring now for Regulatory Affair Project Manager jobs are Medpace, Inc., Medpace, Inc., UCLA Health,

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