Senior Regulatory Affairs Specialist Jobs in Westford, MA

Join us to lead risk-based quality management in clinical trials, driving comprehensive quality assessments and ensuring inspection readiness. Collaborate with teams to uphold high standards in pharma...

Lead the charge in supplier quality management, ensuring compliance to industry standards while overseeing NPI and production operations. Collaborate with cross-functional teams to drive supplier perf...

Transform compliance operations by performing QA tasks to ensure GMP standards are met during clinical trials and production, collaborating with QA, QC, and Manufacturing teams to foster high-quality...

Elevate the regulatory landscape by guiding strategic promotional communications for Oncology products. Shape impactful messaging while ensuring compliance and aligning with evolving regulations and F...

Redefine global regulatory strategy by leading complex cardiovascular programs, driving optimal results with minimal oversight while engaging with global regulatory agencies for timely approvals and c...

Lead global post-market regulatory compliance strategies by managing vigilance, safety investigations, and lifecycle programs, while collaborating across teams to ensure adherence to international reg...

Accelerate regulatory strategy development for oncology products, leading global initiatives to secure IND/CTA approvals and marketing applications. Collaborate with cross-functional teams to navigate...

Champion regulatory excellence by leading postmarket strategies for product compliance, driving collaboration across teams to ensure timely submissions and navigate complex regulatory landscapes for c...

Shape the future of computer systems validation by leading compliance efforts. Assess new systems, conduct risk assessments, and provide mentorship while ensuring adherence to industry standards in a...

Unlock your potential as a regulatory expert, driving clarity and quality by transforming complex risk concepts into impactful documentation. Collaborate with senior leaders to ensure critical risk de...

Contribute to regulatory excellence by coordinating U.S. submissions, ensuring compliance with FDA standards, and maintaining vital documentation for the Obesity Therapeutic Area, while collaborating...

Accelerate our quality assurance efforts by implementing and managing robust Quality Systems for GMP Manufacturing and Testing, ensuring compliance and fostering cross-functional collaboration across...

Unlock your potential by overseeing site management and monitoring for clinical trials, ensuring compliance with regulations and enhancing site relationships to drive quality and timely delivery of cl...

Innovate product labeling strategies and ensure regulatory compliance across development and post-approval processes. Collaborate with diverse teams to align content with regulatory requirements and b...

Lead end-to-end GCP audits globally, ensuring compliance and driving improvements in clinical studies. Collaborate with stakeholders to interpret regulations and support regulatory inspections in a dy...

Drive regulatory data strategy and governance, enhancing tradition with innovation. Collaborate cross-functionally to elevate data quality and execution while ensuring compliance and alignment with gl...

Lead the charge in regulatory CMC strategies for small molecules, ensuring compliance from development to market. Collaborate with cross-functional teams to navigate regulatory complexities and drive...

Drive global CMC regulatory strategies and submissions for clinical and commercial products. Collaborate cross-functionally to ensure compliance, lifecycle management, and timely delivery of high-qual...

Innovate the future of regulatory labeling by driving strategies across global teams, ensuring compliance and quality at all stages of product development while collaborating with key stakeholders to...

Elevate quality assurance oversight through effective deviation investigations and robust corrective actions, ensuring compliance with regulations and continuous improvement within a dynamic team envi...

Drive quality assurance initiatives at a leading gene therapy facility. Oversee batch record reviews, deviation management, and provide QA oversight for critical manufacturing processes, ensuring comp...

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

Empower your career by providing strategic regulatory guidance for promotional and medical communications, collaborating with diverse teams to ensure compliance and support business objectives in a fa...

Support regulatory strategic input for U.S. promotional materials. Collaborate with cross-functional teams to ensure compliance with FDA regulations while driving business objectives in the healthcare...

Transform regulatory strategies in oncology by leading global submissions, engaging with health agencies, and ensuring compliance with evolving regulations to secure market approvals for innovative mR...