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Senior Regulatory Affair Manager jobs in Chicago, IL

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SENIOR MANAGER, REGULATORY AFFAIRS VENDOR GOVERNANCE

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...

CompanyBiospace
AddressCalifornia, United States
CategoryInformation Technology
Job typeFull time
Date Posted 3 weeks ago See detail

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...

3 weeks 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...

a month ago seen See more...

Senior Manager, Regulatory Affairs Biocides - Remote

Steris

Alpharetta, GA

Home Based / Remote opportunity. 20% Domestic Travel Required. 10% International Travel Required. Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compl...

2 months ago seen See more...

Senior Manager, Regulatory Affairs

Apellis Pharmaceuticals

Remote

$132K - $167K a year

Manage, review and organize documents intended for regulatory submissions. Act as a liaison with project teams to accomplish specific regulatory deliverables (eg agency meeting briefing materials, orphan designation applications,...

2 months ago seen See more...

Senior Manager, Regulatory Affairs, CMC

Beigene

Remote

$133,400 - $178,400 a year

Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-appro...

2 months ago seen See more...

Senior Manager, Regulatory Affairs - Product Development

Arthrex

Naples, FL

$114K - $145K a year

Develop and implement regulatory strategies for Product Development and continuous improvement projects, ensuring alignment with business objectives and regulatory requirements. Lead assigned team(s) in establishing short-term and...

2 months ago seen See more...

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...

6 days ago seen See more...

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...

2 weeks ago seen See more...

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...

2 weeks ago seen

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...

4 weeks ago seen See more...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...

a month 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...

2 months ago seen See more...

Regulatory Affairs Manager - Electrophysiology

Abbott Laboratories

Minnesota, United States

$95,000 - $190,000 a year

Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer con...

2 months ago seen See more...

Regulatory Affairs Manager II

Bio-Rad Laboratories, Inc.

Irvine, CA

$149,000 - $204,800 a year

Advise site-based teams of appropriate actions in response to identified product compliance requirements. Lead QSD Regulatory Affairs team to meet business needs for product premarket approvals, clearances, and registrations neede...

2 months ago seen See more...

Regulatory Affairs Manager

Blueroot Health

United States

$111K - $140K a year

Oversight for coordination and execution of regulatory requirements (as defined under DSHE, NLEA, Medical Foods and Medical Devices) and procedures, ensuring full compliance across all brands of the Company. Management coordinatio...

2 months ago seen See more...

Senior Manager, US Medical Advertising and Promotions Regulatory (GI)

Biospace

Lexington, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.About the role:Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review, GI where you will be an interna...

4 weeks 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...

a month ago seen See more...

Manager, Regulatory Affairs - Biosense Webster, Inc.

Johnson & Johnson

Irvine, CA

...

a month ago seen See more...

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 month ago seen See more...

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,...

a month ago seen See more...

Manager Regulatory Affairs

Philip Morris

Washington, United States

Were totally transforming our business and building our future on one clear purpose to deliver a smoke-free future.In late 2022, PMI acquired Swedish Match and its leading oral nicotine product portfolio. Monitors & facilitates...

2 months ago seen See more...

Regulatory Affairs Senior Consultant

Medenvoy Global Bv

Remote

From $100,000 a year

Reviewing and processing of serious incidents related of medical devices of customers. Supervision of field safety corrective actions performed by clients. Communication with competent authorities and clients. Addressing post mark...

2 months ago seen See more...

Manager, Regulatory Affairs

Bausch + Lomb

Remote

$90,000 - $130,000 a year

BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. to analyze impact on Company produc...

2 months ago seen See more...

Regulatory Affairs Associate Manager

Comtec

Remote

$35 - $43 an hour

Validate product composition, ingredient lists, develop nutritionals and advise on/approve regulated claims for compliance under US laws and regulations. Participate in validation of marketing campaigns and review of associated ma...

2 months ago seen See more...

CMC 2 Manager- Regulatory Affairs

Raise In Partnership With Genpact

United States

$103K - $131K a year

Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers Experience in...

2 months ago seen See more...

Manager, Regulatory Affairs - Devices

Allergan Aesthetics

Irvine, CA

$125K - $158K a year

Represents US Regulatory in project teams. Develops US regulatory filing strategy, with input from supervisor. Provides regulatory strategy and guidance to global product owner/project team in line with commercial objectives. Work...

2 months ago seen See more...

Sr. Manager, Regulatory Affairs CMC (Remote)

Ptc Therapeutics

Remote

Leads and manages the development of Module 2 and 3 CMC documents for regulatory filings such as INDs/IMPDs/CTAs and MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards and ar...

2 months ago seen See more...

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...

2 months ago seen See more...

Regional Manager of Quality & Regulatory Affairs

Alaska Dialysis

Alaska, United States

$81.7K - $103K a year

Responsible for overseeing regulatory and growth perspective in accordance with Company goals. Assist in clinical operational development and transition of new or acquired clinic(s) as needed or requested. Assess and integrate cli...

2 months ago seen See more...

Senior Counsel, Regulatory & Legislative Affairs

The Clearing House

Remote

$135K - $171K a year

JD and Licensed attorney, preferably in NY or DC. 5-10 years experience working on payments-related matters in a law firm, bank, or regulatory agency, or on advocacy for the financial industry. Demonstrated ability to quickly gra...

2 months ago seen See more...

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