Regulatory Affair Specialist jobs in Lexington, MA
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REGULATORY AFFAIRS SPECIALIST
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...
| Company | Convatec |
|---|---|
| Address | Lexington, MA |
| Category | Information Technology |
| Salary | $49.4K - $62.5K a year |
| Date Posted | 6 days ago See detail |
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...
6 days ago seen See more...
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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...
a month ago seen See more...
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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...
a month ago seen See more...
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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...
a month ago seen See more...
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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...
2 months ago seen See more...
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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...
2 weeks ago seen See more...
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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...
3 weeks ago seen See more...
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Corporate Affairs Specialist II
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...
5 days ago seen
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...
6 days ago seen See more...
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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...
7 days ago seen See more...
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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...
2 weeks ago seen
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...
2 weeks ago seen See more...
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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...
2 weeks ago seen See more...
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Clinical Research Regulatory & Quality Specialist
Insight
Chicago, IL
Able to provide eligibility for employment for any U.S. employer Bachelors Degree in Research Science or related field required Masters Degree desired in related field to Clinical Sciences Strong working knowledge of FDA CFR 21...
a week ago seen See more...
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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...
2 weeks ago seen See more...
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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...
3 weeks ago seen See more...
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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...
3 weeks ago seen See more...
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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...
3 weeks ago seen See more...
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Budget Specialist for Academic & Student Affairs
Georgia Gwinnett College
Georgia, United States
4 Year / Bachelor's Degree. Three (3) years of experience in higher education. Five (5) years of experience in a general office environment with accounting experience. Graduate Degree. Three or more years of experience in higher e...
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...
4 weeks ago seen See more...
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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...
4 weeks ago seen See more...
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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...
4 weeks ago seen See more...
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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...
4 weeks ago seen See more...
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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...
4 weeks ago seen See more...
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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,...
4 weeks ago seen See more...
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...
4 weeks ago seen See more...
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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...
a month ago seen See more...
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