45 results for Regulatory Manager Jobs in Needham, MA, US

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology...

Why Sarepta? Why Now?The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene ther...

SUMMARYThe Senior Manager of Regulatory Affairs will lead the regulatory compliance and labeling function, ensuring that products comply with all applicable regulations, laws, and standards in the markets where they are sold. This position requires strong regulatory knowledge, excellent communicatio...

Position SummaryResponsible to manage a regulatory team to oversee all aspects of the pre-market or post-market regulatory activities required to maintain compliance to US FDA, Health Canada, European IVD Directive 98/79/EC and European IVD Regulation (EU) 217/746, MDSAP country regulations, as well...

Responsible for overseeing the planning, creation, and submission of regulatory submissions, managing high-quality global submissions, and ensuring compliance with international eCTD requirements. Acts as a team leader, provides direction and mentorship, performs quality control of documents, and de...

Responsible for U.S. regulatory strategy and submissions for medical device software, including leading regulatory submissions, ensuring compliance with quality management systems, and mentoring teams on regulatory practices. Collaborates with cross-functional teams and supports audits and training ...

Responsible for managing regulatory activities, preparing and submitting regulatory documents, ensuring compliance with regulations, and supporting clinical programs. Key tasks include leading submissions to health authorities, reviewing critical documents, planning regulatory activities, and partic...

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Participate in defining and implementing Regulatory CMC strategy for gene therapy programs, support planning and submission of Regulatory CMC content, collaborate with Technical Operations for CMC development, prepare responses to regulatory inquiries, and contribute to global life cycle management ...

Lead or co-lead for one RA CMC development and/or marketed product, providing support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. Develops documentation for global Health Authority interactions, coordinates document submissions, and ensures compliance with regulatory expectat...