Regulatory Operations Specialist

2 weeks ago


Boston, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

We are seeking a highly skilled Regulatory Operations Contractor to join our team at Beacon Hill Life Sciences in Boston. This is a contract position through the end of the year with possible extension.

About the Job

The successful candidate will assist in the development and implementation of systems and procedures used to support regulatory submission activities, including eCTD production, document publishing, and document management.

This role requires strong technical skills, excellent communication and interpersonal abilities, and experience compiling electronic submissions and in electronic document publishing.

Responsibilities
  • Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination of system development activities;
  • Coordinate and participate in the production of electronic regulatory submissions;
  • Support and conduct cross-functional training on submission standards, procedures, and systems as required;
  • Support compliance with worldwide submission regulations and guidelines.
Requirements
  • Experience compiling electronic submissions and in electronic document publishing;
  • Experience compiling IND, NDA/BLA, and CTD submissions;
  • Understanding of eCTD submission requirements;
  • Excellent communication and interpersonal skills;
  • Demonstrated ability to work well with cross-functional teams;
  • Demonstrated ability to manage priorities and work under tight deadlines;
  • 2+ years of pharmaceutical industry experience preferred;
  • Proficient with Microsoft Office products and Adobe Acrobat.
What We Offer
  • A competitive salary of $$80,000 - $110,000 per year, depending on experience;
  • A dynamic and supportive work environment;
  • Ongoing training and professional development opportunities;
  • A comprehensive benefits package.


  • Boston, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    About the JobBeacon Hill Life Sciences - Boston seeks a highly skilled Regulatory Operations Contractor to support regulatory submission activities, including eCTD production, document publishing, and document management.Job SummaryThis role involves assisting in the development and implementation of systems and procedures used to support regulatory...


  • Boston, Massachusetts, United States Jobot Full time

    As a Litigation and Regulatory Specialist, you will play a critical role in our firm's litigation and regulatory practice, providing expert advice on complex environmental issues and representing clients in regulatory proceedings. This is a unique opportunity to work on high-profile cases, develop your expertise in environmental law, and collaborate with a...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    At Takeda Pharmaceutical, we are seeking an experienced Regulatory Operations Leader to join our team. This role will be responsible for driving the development and implementation of our Global Regulatory Affairs Operations vision and strategy.Key Responsibilities:Develop and maintain a comprehensive understanding of regulatory requirements and guidelines to...


  • Boston, Massachusetts, United States Jobot Full time

    We are seeking a Regulatory Operations Lead to join our team at Jobot. As a key member of our regulatory affairs department, you will play a critical role in ensuring our organization's compliance with FDA and other relevant regulations.About the RoleThis is an exciting opportunity to lead and manage a team of regulatory professionals, providing guidance and...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job SummaryTakeda Pharmaceutical seeks a Regulatory Operations Director to lead the formulation and implementation of the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy. This role will involve envisioning and implementing a digital innovation ecosystem across GRA, R&D, and the enterprise.Main ResponsibilitiesStrategic Thought Partnership:...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Takeda Pharmaceutical is seeking a highly skilled Global Regulatory Operations Strategist to lead our regulatory affairs efforts. This is an exceptional opportunity to join a dynamic team and contribute to the development of innovative pharmaceutical solutions.Job SummaryWe are looking for a seasoned professional with extensive experience in regulatory...


  • Boston, Massachusetts, United States RQMIS Inc Full time

    Job OverviewRQMIS Inc, a leading medical device/biotechnology consultancy, is seeking an experienced Regulatory Documentation Specialist to join our team in Amesbury, MA. As a key member of our team, you will play a crucial role in supporting projects involving labeling, regulatory submissions, quality system documentation, and clinical study material.Key...


  • Boston, Massachusetts, United States Fidelity Investments Full time

    Job OverviewWe are seeking a highly skilled Digital Compliance Specialist to join our team in this critical role, overseeing regulatory oversight and management for Fidelity Digital Asset Services.About the RoleThis position involves working closely with decentralized teams and collaborating with various stakeholders across Fidelity to promote a culture of...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    As Head of Global Regulatory Operations, you will be responsible for shaping and implementing the company's global regulatory strategy. With a strong background in pharmaceutical drug development, you will lead a medium to large organization and influence senior-level management and key stakeholders. Your expertise in operational experience, business process...


  • Boston, Massachusetts, United States ArkeaBio Full time

    Job SummaryThe Regulatory Affairs Specialist at ArkeaBio will be responsible for preparing and reviewing regulatory documents for a novel veterinary product across multiple international jurisdictions. This role requires a strong understanding of regulatory requirements, excellent organizational skills, and the ability to work independently while...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleWe are seeking an experienced Senior Global Regulatory Operations Strategist to join our team at Takeda Pharmaceutical. As a key member of our Global Regulatory Affairs Operations organization, you will play a critical role in formulating and implementing our vision and strategy for a best-in-class regulatory operations organization.


  • Boston, Massachusetts, United States PathAI Full time

    Job Title: Principal Regulatory Affairs SpecialistWe are seeking an experienced Principal Regulatory Affairs Specialist to play a key role in supporting regulatory strategies and ensuring the success of our diagnostic products in the global market.Key Responsibilities:Regulatory Submissions and Documentation: Prepare and manage regulatory submissions,...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:Takeda Pharmaceutical is a patient-focused company committed to delivering Better Health and a Brighter Future to people around the world.We are seeking an experienced Regulatory Affairs Director, Global CMC Specialist to oversee the development and execution of regulatory CMC strategies for our pharmaceutical products.This role requires a...

  • Regulatory Expert

    3 weeks ago


    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleAt Takeda Pharmaceutical, we are a world-class R&D organization dedicated to unlocking innovation and delivering transformative therapies to patients worldwide. Our forward-thinking approach enables us to push the boundaries of what is possible in the field of pharmaceuticals.We are seeking a highly skilled Regulatory Expert - Device and...


  • Boston, Massachusetts, United States Digital Prospectors Full time

    About the RoleWe are seeking a detail-oriented and independent Quality Operations Specialist to join our dynamic team supporting the Quality Assurance (QA) function for commercial product stability programs.This role provides QA analytical support, ensuring compliance and quality standards are maintained across various stages of product stability. You will...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleWe are seeking a seasoned Regulatory Affairs professional to lead our Global Regulatory Operations team. As Head, Global Regulatory Operations, you will be responsible for formulating and implementing the GRA-Ops vision and strategy, driving innovation and excellence in regulatory operations across the organization.


  • Boston, Massachusetts, United States Lifelancer Full time

    About the JobWe are seeking an experienced Associate Director to join our Global Regulatory Affairs team as a Global Regulatory Project Management Lead. This role will provide strategic leadership and guidance on global regulatory project management for moderately complex programs and submissions.The ideal candidate will have a minimum of 8 years of...


  • Boston, Massachusetts, United States Lifelancer Full time

    Unlock Your Potential in Global Regulatory AffairsTakeda is a patient-focused company that transforms patient care through novel specialty pharmaceuticals and best-in-class patient support programs.As an Associate Director, Global Regulatory Project Management and Strategic Planning - GI2 TAU, you will be part of our Global Regulatory Affairs organization,...


  • Boston, Massachusetts, United States HR4ALL Full time

    **Job Title:** Regulatory Law Specialist for Intellectual Property DepartmentAbout HR4ALL:We are a global law firm seeking talented professionals to join our team.About the Role:This is an exciting opportunity to work as a mid-level associate in our Hatch Waxman Practice Group within the Intellectual Property Department. Our ideal candidate will have 3+...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About Takeda PharmaceuticalTakeda Pharmaceutical is a leading pharmaceutical company that aims to deliver better health and a brighter future for people worldwide.Job Summary:We are seeking an experienced professional to lead our Global Regulatory Affairs Operations, formulating and implementing a vision and strategy to achieve best-in-class organization. As...