regulatory affairs coordinator Jobs in Danvers, Massachusetts

Manager
Waltham, MassachusettsDeciphera PharmaceuticalsJob Description The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for...Full Job Details
Manager
Cambridge, MassachusettsBiogenJob Description Manager, Global Regulatory Affairs About This Role The Global Regulatory Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for development and marketed products. You are a member...Full Job Details
SVP Global Regulatory Affairs
Waltham, MassachusettsDyne TherapeuticsCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide...Full Job Details
Senior Manager
Cambridge, MassachusettsEditas MedicineAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential...Full Job Details
Regulatory Affairs Manager
Boston, MassachusettsDennis Partners Our client is developing precision delivery platforms for the treatment of neurological and oncological disorders. They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements....Full Job Details
Director
Boston, MassachusettsOlema Oncology Who We Are Why You Should Work With Us Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a...Full Job Details
Regulatory Affairs Specialist III US
Mansfield, MassachusettsMindlanceSUMMARY DESCRIPTION 1) Independently provide EU regulatory requirements and guidance to EU MDR project teams. 2) Lead the preparation of the EU MDR technical documentation for Class III, IIa, IIb, or Class I sterile or reusable medical devices to support timelines for CE...Full Job Details
Regulatory Affairs Specialist III
Mansfield, MassachusettseTeam Inc.Remote Description: 1) Independently provide EU regulatory requirements and guidance to EU MDR project teams. 2) Lead the preparation of the EU MDR technical documentation for Class III, IIa, IIb, or Class I sterile or reusable medical devices to support timelines for CE...Full Job Details
Regulatory Affairs Manager
Cambridge, MassachusettsKatalyst Healthcares & Life SciencesResponsibilities: However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee...Full Job Details
Associate Director
Boston, MassachusettsProClinical Associate Director, Regulatory Affairs - Boston, MA - Permanent Proclinical is seeking a strategic regulatory leader to join a renowned biotech. This is a permanent position located in Boston, MA. Primary Responsibilities: The primary focus of this role is to work with...Full Job Details
Regulatory Affairs Specialist III
Mansfield, MassachusettsAditi ConsultingSummary: Independently provide EU regulatory requirements and guidance to EU MDR project teams. Lead the preparation of the EU MDR technical documentation for Class III, IIa, IIb, or Class I sterile or reusable medical devices to support timelines for CE marking and EU...Full Job Details
Manager
Boston, MassachusettsTakeda 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 Takeda's Privacy Notice and Terms of Use . I further attest that all information...Full Job Details
Global Regulatory Affairs Lead
Cambridge, MassachusettsSanofi Global Regulatory Affairs Lead (GRL) Mission statements The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi's...Full Job Details
Director
Waltham, MassachusettsDyne TherapeuticsCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide...Full Job Details
Director/Assoc Director Regulatory Affairs
Boston, MassachusettsApex SystemsDirector/Assoc Director Regulatory Affairs Associate Director/Director, Regulatory Affairs Location: Boston, MA(Remote) Therapeutic Areas : Neuro Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory...Full Job Details
Director
Boston, MassachusettsTakedaDirector, Regulatory Affairs Vaccines CMC Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is...Full Job Details
Associate Director
Lexington, MassachusettsAccede Solutions IncHybrid Role The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This position will oversee CMC Health Authority submissions, collaborating across the business and with external...Full Job Details
Director
Boston, MassachusettsTakeda 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 Takeda's Privacy Notice and Terms of Use . I further attest that all information...Full Job Details
CMC Regulatory Affairs Program Manager
Cambridge, MassachusettsKatalyst Healthcares & Life SciencesResponsibilities: Responsible to communicate new regulatory guidelines. Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards are properly and timely implemented....Full Job Details
Senior Director/Director
Norwood, MassachusettsCorbus PharmaceuticalsJob Description General Description: As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus' drug development by developing and overseeing the execution of regulatory strategy in the US/EU and other territories deemed applicable....Full Job Details
Associate Director
Cambridge, MassachusettsSanofi The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and...Full Job Details
Sr Regulatory Affairs Associate
Waltham, MassachusettsFresenius Medical CareThis position can be fully remote Global Regulatory experience needed. Demonstrated project management experience needed. PURPOSE AND SCOPE: Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and...Full Job Details
Regulatory Affairs Associate II Pharma
Waltham, MassachusettsFresenius Medical CareThe ideal candidate should have US Advertising and Promotion experience. This position can be fully remote. PURPOSE AND SCOPE: Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing...Full Job Details
Project Manager
Danvers, MassachusettsLeadstack IncJob Title: Project Manager (Medical & Scientific Affairs) Location: Danvers MA 01923 - 100% Remote Duration: 12 month(s) Pay Rate: $65/hr Prefer candidates in PST or CST time zone. Part-Time: 20+ hours a week Description/Comment: The Medical and Scientific Affairs function...Full Job Details
Project Manager
Danvers, MassachusettsTechDigital CorporationDescription/Comment: The Medical and Scientific Affairs function provides leadership and direction on medical, scientific and clinical decisions related to the overall Leica Biosystems business strategy. The Medical Affairs Operations manager is responsible for the...Full Job Details