Regulatory Affairs Specialist Jobs in Burlington, MA

Transform regulatory affairs by leading global strategy for oncology programs. Partner cross-functionally to navigate IND submissions and health authority interactions, ensuring successful Phase 1 and...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Unlock potential by leading regulatory compliance for advertising and promotional materials, guiding cross-functional teams in strategic initiatives, and ensuring adherence to industry standards and F...

Lead impactful QA/RA initiatives to enhance compliance and quality systems for medical device clients. Drive innovative strategies using AI technology to shape the future of regulatory affairs and ens...

Unlock potential by shaping global regulatory strategies and driving advocacy initiatives. Collaborate across teams to manage regulatory risks, assess opportunities, and provide strategic insights tha...

Collaborate with cross-functional teams to oversee regulatory activities for a portfolio of Pharmaceutical Diagnostics products, ensuring compliance and strategic alignment with global standards throu...

Pioneer regulatory CMC strategies while leading cross-functional teams in the pharmaceutical industry. This role will focus on lifecycle management and submissions across US, CA, and EU markets, ensur...

Advance regulatory strategy and submissions for CMC in pharmaceuticals, collaborating with cross-functional teams to ensure compliance with FDA, EMA, and ICH standards while overseeing product lifecyc...

Join a team that drives regulatory excellence for clinical development, ensuring strategic and compliant submissions. Collaborate cross-functionally to accelerate drug approval processes while oversee...

Take ownership of regulatory affairs operations, leading teams to enhance processes within clinical trials while ensuring compliance with regulations and fostering collaboration across departments...

Transform regulatory strategy and operations across CMC and clinical activities, leading a high-performing team to ensure compliance and successful product approvals from development through post-appr...

Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...

Lead the charge in developing regulatory strategies for managed access programs, guiding clients through global pathways, and enhancing patient access to investigational therapies through strategic in...

Join a global team to shape regulatory strategies in biotechnology, supporting product development and lifecycle management in Inflammation and Rare Diseases. Lead regulatory efforts, ensure complianc...

Join a team that's committed to sustainable practices and regulatory compliance. This role plays a vital part in ensuring products meet environmental standards while collaborating across functions for...

Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...

Lead the charge in clinical research by monitoring studies across various therapeutic areas, ensuring top-quality standards and effective communication with stakeholders while driving project timeline...

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

Optimize global regulatory strategies to secure market approval for neuroscience products. Lead cross-functional teams, anticipate regulatory risks, and ensure compliance while managing projects throu...

Shape the future of GMP Document Control by managing end-to-end governance, ensuring compliance with regulatory standards, and driving continuous improvement in documentation and records management pr...

Shape the future of pharmaceutical development by leading regulatory CMC strategies to support investigational and post-approval product success. Collaborate with cross-functional teams to ensure comp...

Lead the charge in managing CDMO vendor relationships while ensuring seamless logistics, performance tracking, and communication across drug substance programs. Drive operational excellence and elevat...

Unlock potential by leading global regulatory CMC activities, developing strategies for product lifecycle management, and collaborating across teams to ensure successful agency submissions. Drive tran...

Join a team that's dedicated to ensuring the validation and quality of biopharmaceutical manufacturing equipment through comprehensive testing, planning, and troubleshooting to maintain compliance and...

Drive the assurance of quality by conducting analytical testing on materials and products while supporting method development and validation. Collaborate on special projects and quality initiatives to...