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REGULATORY AFFAIRS CONSULTANT

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development te...

CompanyKatalyst Healthcares And Life Sciences
AddressRahway, NJ
CategoryInformation Technology
Job typeFull-Time
Date Posted 4 weeks ago See detail

Regulatory Affairs Consultant

Katalyst Healthcares And Life Sciences

Rahway, NJ

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development te...

Regulatory Affairs Consultant

Katalyst Healthcares & Life Sciences

Rahway, NJ

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. Participate on product development t...

Director or Senior Director, Regulatory Affairs

Veranex, Inc.

San Jose, CA

$165,000 - $263,000 a year

Responsible for managing and prioritizing workload for regulatory staff. Develops and establish strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients,...

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 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...

Senior Product Stewardship & Regulatory Affairs Specialist Job

Arkema

United, PA

Prepare and maintain commercial and R&D composition databases, SDSs and labels, packaging requirements, certificates of compliance (Kosher, FDA, RoHS etc.), product registrations and approvals (including FIFRA, NSF, UL, etc.), for...

Manager, Global Regulatory Affairs, Marketed Products - Now Hiring

Takeda Pharmaceutical

Bronx, NY

$186,000 per year

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and. I further attest that...

VP/TA Head, General Medicine - Global Regulatory Affairs

Merck

Rahway, NJ

Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.. Contributing to the continuous improvement of the operating model for regulatory a...

Regulatory Affairs Intern (Onsite)-Summer-Fall 2024

Becton Dickinson

Covington, GA

Assist with product submissions and regulatory assessments. Ensure compliance with all relevant regulatory requirements. Improve departmental procedures and processes. Assist with regulatory assessments for design change and non-d...

Manager, Global Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Brooklyn, NY

$133,200.00 to $223,200.00 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 in Cambridge, MA with the...

Consumer Affairs Consultant I

Terra Staffing

Richardson, TX

Provide excellent customer service for questions related to product information. Deescalate and resolve customer concerns. Help educate consumers on equipment and warranty information. Record and document customer calls through co...

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...

Head of Regulatory Affairs Policy & Regulatory Intelligence

Biospace

Thousand Oaks, CA

Lead teams of policy experts and subject matter experts to accomplish policy goals. Recruit and retain highly qualified and diverse professional policy and Regulatory Intelligence professionals, ensuring they are appropriately qua...

Senior Director/Director, Global Regulatory Affairs Early Respiratory & Immunology

Astrazeneca

Boston, MA

Work on cross-project initiatives of high importance for the early R&I portfolio. Lead the development and implementation of innovative global strategies of increasing complexity to improve the likelihood of regulatory success. Ac...

Regulatory Affairs Director, Oncology

Astrazeneca

Waltham, MA

Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.. Develop and implement the program's regional or global strategy ensuring tha...

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...

Sr. Regulatory Affairs Specialist (Andover or Mansfield, MA)

Smith & Nephew

Andover, MA

$115,000 - $130,000 a year

Coordinates associated registration or submissions leading to market clearance/approval. Provide regulatory direction to project teams for product development/design control related activities. Drafting, authoring and submitting P...

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...

Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination

Biospace

North Chicago, IL

Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...

Senior Specialist Regulatory Affairs - Nutrition - Lake County , IL or Columbus, OH

Abbott Laboratories

Lake Forest, IL

$72,700 - $145,300 a year

Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including...

Senior Associate - Regulatory Affairs

Biospace

Princeton, NJ

Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...

Regulatory Affairs Specialist - Labeling

Nesco Resource

Andover, MA

Up to $38.46 •

Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.. Initiates, reviews and a...

Regulatory Affairs Associate III

Teva Pharmaceuticals

Lorida, FL

Who we areTogether, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Write, review and compile documentation and data necessary for submission of assig...

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...

USA Regulatory Affairs Specialist Project Lead I Scientific

Adecco

Bridgewater, NJ

$ 88 - $ 89.22 / Hour

Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...

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...

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...

FSO, Business Consulting Financial Regulatory Reporting Manager

York State Department Of Labor

New York, NY

Support client engagement teams at a wide variety of FSO clients to deliver professional services and participate in business development activities on strategic and global priority accounts.. Serve in an execution role to deliver...

Regulatory Affairs Manager (CMC Site)

Biospace

New Albany, OH

Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.. Provi...