Senior Regulatory Affairs Specialist Jobs

Champion regulatory excellence by managing eCTD submissions and ensuring compliance with FDA requirements. Collaborate across teams to maintain documentation standards and training while upholding the...

Collaborate to enhance the ethical oversight of human subjects research. Engage in compliance oversight, analyzing incident reports, and supporting IRB interactions. Utilize in-depth regulatory knowle...

Lead the charge in ensuring compliance with quality standards and regulatory requirements. This role interfaces with clients and cross-functional teams, supporting product release processes and qualit...

Lead quality improvement initiatives by managing CAPA processes and recalls. Collaborate with cross-functional teams to ensure compliance and enhance the effectiveness of the Quality Management System...

Unlock strategic regulatory leadership; drive compliance and streamlined processes in Canada for diverse drug and biologic products, supporting client success and developing innovative solutions in a...

Drive regulatory strategy and client interactions in the Canadian market. Lead a team to secure new business, enhance process improvements, and deliver strategic regulatory advice. Be the subject matt...

Elevate quality compliance standards by supporting GCP compliance, vendor oversight, and audit activities for clinical studies, ensuring adherence to regulations while fostering collaboration across t...

Elevate your career by developing and executing regulatory strategies that support compliance and optimize operations across midstream assets. Engage with stakeholders to ensure business objectives al...

Take ownership of the electrical design process for innovative medical imaging systems, collaborating with cross-functional teams to deliver life-saving technology. Drive complex hardware challenges w...

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...

Join a team championing Quality Assurance initiatives, enhancing operational efficiency, and fostering a culture of excellence. Collaborate across functions to address quality gaps, ensuring complianc...

Join a team that's pioneering innovative CMC regulatory strategies for biologics and pharmaceuticals, managing submissions, and providing strategic client support through all stages of drug developmen...

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...

Join a team that drives innovative CMC regulatory strategies for global cell therapy products and supports cross-functional collaboration while ensuring compliance with evolving standards...

Drive global CMC strategy for transformative cell and gene therapies, ensuring seamless regulatory pathways and efficient product approvals through collaborative leadership and strategic risk manageme...

Make your mark at the forefront of diabetes innovation, leading regulatory strategies for groundbreaking medical devices and ensuring compliance throughout product development, ultimately improving pa...

Advance your career by ensuring reliable operations of critical biopharma equipment. Collaborate with teams to troubleshoot, support maintenance, and improve asset reliability in a dynamic, regulatory...

Shape the future of quality assurance by leading a dynamic team, driving root cause analysis, and enhancing processes to ensure product excellence in a regulated environment. Collaborate on audits and...

Unlock potential by leading global regulatory strategies in cardiovascular and metabolic programs. Collaborate with cross-functional teams to ensure timely drug approvals while managing complex projec...

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 the charge in global regulatory strategy development for innovative cardiovascular programs, ensuring efficient approval processes and strategic oversight to accelerate drug advancements through...

Unlock your potential as a strategic leader in global regulatory affairs, driving innovative cardiovascular solutions and ensuring rapid approval processes while managing complex development programs...

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...

Engage in leadership and strategic oversight of Regulatory Affairs, ensuring compliance with nuclear regulations while driving CNL's operational excellence in the nuclear sector. Facilitate interactio...

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...