Senior Regulatory Affairs Specialist Jobs in Mansfield, MA

Drive compliance and quality in GxP software and equipment through assessments, documentation, and vendor oversight. Collaborate with cross-functional teams to ensure reliable inputs and maintain insp...

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...

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...

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...

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...

Lead regulatory strategy for clinical-stage radiopharmaceuticals, ensuring compliance and effective health authority engagement. This pivotal role demands substantial experience in biotech regulations...

Lead digital quality initiatives, ensuring compliance in computer system validation across regulatory and R&D landscapes. Drive GxP adherence through collaborative support and risk assessments, enhanc...

Shape the future of drug substance development by leading regulatory strategies for starting materials. Collaborate cross-functionally and ensure compliance with global regulations to support late-sta...

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 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...

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...

Take ownership of quality control digital transformation initiatives, supporting AI-driven solutions and collaborating across teams to enhance laboratory operations and compliance with regulatory stan...

Champion the validation of cutting-edge lab instrumentation while collaborating with diverse teams to ensure customer readiness and operational excellence. Your expertise will drive quality and compli...

Join our team to enhance compliance culture, driving quality and safety standards through effective investigations, documentation, and training in a dynamic manufacturing environment. Your expertise w...

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...

Lead the charge in supplier quality enhancement initiatives, ensuring compliance with industry standards while driving continuous improvement across hardware solutions. Collaborate with cross-function...

Champion continuous improvement initiatives within the supply base, managing supplier corrective actions, conducting audits, and collaborating cross-functionally to ensure high quality standards are m...