Senior Regulatory Affairs Specialist Jobs in Billerica, MA

Lead the development and execution of US regulatory strategies, ensuring compliance and expedited pathways for innovative therapies. Collaborate with global teams and regulatory bodies to drive produc...

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...

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...

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...

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...

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...

Transform regulatory writing by leading complex submissions, mentoring teams, and ensuring compliance. Drive innovation and improve processes while collaborating across teams to enhance product succes...

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...

Champion the management of complex contracts and claims for impactful capital projects. Utilize your extensive experience in strategic negotiation, risk assessment, and commercial management to drive...