Regulatory Affairs Associate jobs in Minnesota

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REGULATORY AFFAIRS ASSOCIATE MANAGER

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...

CompanyComtec
AddressRemote
CategoryInformation Technology
Salary$35 - $43 an hour
Job typeContract
Date Posted a month ago See detail

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...

Regulatory Affairs Associate (On-Site / Remote)

Imbed Biosciences, Inc

Remote

$67.4K - $85.4K a year

Research and interpret regulations related to the development, manufacturing, and marketing of products in the Medical Device industry. Review product labeling, packaging, and promotional materials to ensure compliance with regula...

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...

Associate Director, Regulatory Affairs - West Chester, PA

Teva Pharmaceuticals

United States

Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...

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...

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...

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...

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...

Associate Vice President, International Government Affairs

Biospace

Washington, United States

Be the accountable single point of contact for International Government Affairs and direct liaison for the Executive VP of Lilly International Business Unit. Lead the International vision and strategy, planning and achieving of hi...

Associate Director, Global Medical Affairs Phase 4 Research in HIV Treatment

Biospace

California, United States

Lead and support GMA-led Phase 4 Research studies in HIV Treatment, specifically for B/F/TAF data generation priorities related to the IRA submission, and as articulated through Gilead strategy documents [BVY indication strategic...

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...

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...

Principal Regulatory Affairs Specialist (medlance.co)

Medlance

Remote

$30 - $300 an hour

Lead regulatory strategy development for medical device projects. Manage submissions to regulatory bodies. Advise on regulatory requirements and changes. Collaborate with cross-functional teams for regulatory compliance. Extensive...

Regulatory Affairs Specialist

Redbock- An Nes Fircroft Company

Remote

$70.9K - $89.8K a year

Prepare and maintain international submission dossiers. Prepare electronic pre-market and post-market regulatory submissions. Compile Technical Documentations for IVD medical devices. Monitor progress on project deliverables and p...

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...

Regulatory Affairs Specialist

Brs

Remote

$62.1K - $78.7K a year

Contractor shall have at least 5 years experience applying FDA research regulatory requirements within a research Regulatory Affairs program office. Work in preparing ones own research proposals and ones own submissions to an IR...

Director, CMC Regulatory Affairs Biologics

Biospace

California, United States

Lead CMC regulatory strategy for a single or multiple products. Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of pro...

Regulatory Affairs Specialist II

Bausch + Lomb

Remote

$65,000 - $95,000 a year

Responsible for general knowledge of pharmaceutical, consumer and medical device regulations in Regional and Local markets. Partners closely with cross-functional stakeholders to document registration strategy and implementation p...

Director, Regulatory Affairs Advisor & Liaison

Capital One

Virginia, United States

Enjoy working with banking regulators Closely follow digital and technological developments in banking and financial services Understand and appreciate technology and cyber security risk management Relish interacting with senior l...

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...

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...

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,...

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...

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...

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...

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...

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...

Senior Regulatory Affairs Advisor

Cook Device Solutions

Remote

$100,000 - $125,000 a year

Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market, including but not limited to FDA 510(k) submissions and EU MDR Technical Files. Manages communications with regulat...

Regulatory Associate

Clinirx

California, United States

$76.6K - $97K a year

Our compensation and benefits packages are tailored to match your talent and industry standards, ensuring your efforts are duly rewarded. We provide a supportive platform for every team member to thrive, encouraging innovation and...

Director, International Regulatory Affairs Advertising & Promotion (Remote Eligible)

Abbvie

Illinois, United States

$159K - $201K a year

Reviews and evaluates the global industry environment (e.g., regulatory, legal, and political climate), and plans strategically for overall system of regulatory communications. Provides functional input on key initiatives impactin...