Biologics Regulatory Affairs Director

6 days ago


Cambridge, Massachusetts, United States Takeda Full time
Job Summary

We are seeking a highly skilled Biologics Regulatory Affairs Director to join our team at Takeda. As a key member of our GRA CMC team, you will be responsible for developing and executing regulatory strategies for assigned products.

Responsibilities:
  • Develops, executes, and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy.
  • Guides the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirements.
  • Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC-related matters.
Requirements:
  • Bachelor's degree in a scientific discipline; advanced degree required.
  • 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and/or devices experience.
  • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
Salary Range:

$140,000 - $180,000 per year, depending on experience.



  • Cambridge, Massachusetts, United States Takeda Full time

    About the RoleWe are seeking an experienced Global Regulatory Affairs Director to join our team in Cambridge, MA. In this role, you will play a key part in developing and executing regulatory strategies for biologics development.Job DescriptionAs a Global Regulatory Affairs Director, you will be responsible for leading the execution of regulatory CMC...


  • Cambridge, Massachusetts, United States Takeda Full time

    About TakedaTakeda is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. By focusing our efforts on four therapeutic areas, we push the boundaries of what is possible in order to bring life-changing therapies to patients globally.At Takeda, we are transforming patient care through the...


  • Cambridge, Massachusetts, United States 9627 Corixa Corporation Full time

    We are seeking a talented Facilities Regulatory Affairs Strategic Lead to join our team at GSK, a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together.The estimated salary for this position is $120,000 - $160,000 per year, depending on experience and qualifications. This role offers a...


  • Cambridge, Massachusetts, United States Jobot Full time

    About the RoleWe are seeking a highly experienced Director of Biologics Quality Assurance to provide quality oversight of our clinical development programs and manufacturing.The ideal candidate will be an expert in biologics, specifically operational QA experience with monoclonal antibodies, and have a strong background partnering with external...


  • Cambridge, Massachusetts, United States Apnimed Full time

    About the RoleWe are seeking a seasoned Strategic Regulatory Affairs Leader to drive our regulatory and quality assurance efforts for pharmaceutical products and sleep monitoring devices. This is an exciting opportunity to develop and implement the regulatory affairs strategy that will propel major paradigm shifts in the treatment of sleep apnea.


  • Cambridge, Massachusetts, United States Bicycle Therapeutics Full time

    OverviewBicycle Therapeutics is a pioneering pharmaceutical company dedicated to developing novel, life-changing medicines. As a key member of our team, you will play a crucial role in shaping the future of medical affairs strategy.About the RoleThe Associate Director/Director, Medical Affairs Strategy will be responsible for leading scientific and medical...


  • Cambridge, Massachusetts, United States Jobot Full time

    We are a publicly traded biotechnology company developing innovative solutions to treat chronic dermatological diseases.Job OverviewThis role is part of our clinical development programs and manufacturing, ensuring the highest standards of quality oversight.Key ResponsibilitiesProvide quality support and guidance for CMC programsPlan, conduct or facilitate...


  • Cambridge, Massachusetts, United States Takeda Full time

    About TakedaTakeda is a patient-focused company that drives innovation in specialty pharmaceuticals and patient support programs.We are certified as a Global Top Employer and strive for excellence in everything we do, fostering an inclusive and collaborative work environment where our teams are united by an unwavering commitment to deliver Better Health and...


  • Cambridge, Massachusetts, United States Third Rock Ventures Full time

    Job OverviewWe are seeking a Senior Manager/Associate Director, Quality Control to join our CMC team at Third Rock Ventures Stealth NewCo. This role will lead and independently perform technical and operational aspects of QC activities for antibody and fusion protein products across the company's pipeline.About the RoleDevelop and execute QC strategies for...


  • Cambridge, Massachusetts, United States Bicycle Therapeutics Full time

    Job OverviewBicycle Therapeutics, a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases, seeks a Senior Director/Director, Medical Affairs Strategy to drive scientific and medical excellence across the organization. This key role will lead global and US medical affairs strategic planning, ensuring alignment with...


  • Cambridge, Massachusetts, United States Insight Global Healthcare Full time

    Job OverviewClinical Affairs Consultant - 8 month contract + possible extensions/conversion. Hybrid role, 3X week on-site in Bothell, WA or Cambridge, MA.About the RoleAs a Clinical Affairs Consultant, you will play a key part in generating evidence to support Philips' regulatory clearances, claims, and market access. You will lead the development of...


  • Cambridge, Massachusetts, United States Catalytic Data Science Full time

    About Catalytic Data ScienceCatalytic Data Science is a pioneering start-up revolutionizing the life sciences industry by leveraging cutting-edge AI platforms to enhance Regulatory Affairs Intelligence.


  • Cambridge, Massachusetts, United States AbbVie Full time

    OverviewAbsorb the challenges of AbbVie's mission to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.Salary RangeThe estimated salary for this position is between $160,000 and $200,000 per year, depending on qualifications and location. In addition to a...


  • Cambridge, Massachusetts, United States Takeda Full time

    About the OpportunityWe are seeking a highly skilled Manager of Statistics to join our Pharmaceutical Sciences team in Cambridge, MA.Job SummaryThis role will provide statistical leadership in the design, analysis, and interpretation of CMC study data throughout Pharmaceutical Sciences, promoting innovative design and analysis methodology.Key...

  • Data Director

    3 days ago


    Cambridge, Massachusetts, United States Vesalius Therapeutics Full time

    About Vesalius TherapeuticsVesalius Therapeutics is a pioneering company that is revolutionizing the field of medicine by developing a platform to generate breakthrough treatments for common diseases. Our platform combines large-scale human genetics, genomics, stem cell studies, and artificial intelligence to uncover causal biology and identify optimal...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    About the RoleJoin Lifelancer, a talent-hiring platform connecting professionals with opportunities in life sciences and technology, as we seek a highly experienced Clinical Data Management Lead to spearhead data management activities for Alnylam's clinical studies.This challenging role requires a seasoned professional with at least 7 years of experience in...


  • Cambridge, Massachusetts, United States Harvard University Full time

    Alumni Affairs and Development at Harvard UniversityWe are seeking a highly skilled Director of Events and Advancement to join our dedicated team at Harvard University. This individual will play a key role in supporting the university's advancement activity through front-line fundraising, alumni and volunteer engagement, technology, prospect management, and...


  • Cambridge, Massachusetts, United States Novartis Group Companies Full time

    About the Role:We are seeking a highly experienced professional to lead our Oncology Drug Discovery team in Cambridge, MA. As Senior Oncology Research Director, you will be responsible for progressing innovative biotherapeutics programs, focusing on antibody drug conjugates.Key Responsibilities:Leading a scientific team within Oncology Drug Discovery to...


  • Cambridge, Massachusetts, United States Flagship Ventures Full time

    About This OpportunityWe are seeking an experienced and entrepreneurial Product Lead in the Life Sciences to bring one or more therapeutics from concept to IND.ResponsibilitiesTarget Product Profiles: Develop the Target Product Profiles (TPPs) for valuable new biological therapeutics that can be discovered on our platformLead Therapeutics Programs: Oversee...


  • Cambridge, Massachusetts, United States Randstad North America, Inc. Full time

    **About the Role**We are seeking a highly skilled Clinical Development Scientist to join our team at Randstad North America, Inc. in Cambridge, Massachusetts.**Overview**The Clinical Development Scientist will be part of our Clinical Affairs organization and report directly to the Director of Clinical Affairs.**What You Will Do**You will be responsible for...