Senior Regulatory Affairs Specialist Jobs

Lead the charge in global regulatory strategy for a late-stage immunology program, driving FDA interactions, submissions, and cross-functional decisions while shaping regulatory infrastructure in a dy...

Unlock potential by leading global regulatory submissions for medical devices. You will drive strategy, manage compliance risks, and collaborate across teams to navigate complex regulatory landscapes...

Join a dynamic team to enhance global regulatory compliance and market access for life-saving medical products. Collaborate with cross-functional teams to drive process improvements and navigate compl...

Lead the charge in developing regulatory strategies for Canadian projects, ensuring compliance and collaboration across teams to drive successful product development and submissions in a dynamic, scie...

Manage regulatory submissions for medical devices, ensuring compliance with FDA and ISO standards. Collaborate with cross-functional teams to guide products through regulatory processes and secure tim...

Lead the charge in managing pre-market regulatory activities to ensure compliance with US FDA, Health Canada, and EU IVD regulations. Collaborate with design teams, prepare submissions, and review pro...

Elevate your career by leading regulatory CMC strategies for small molecules and biologics. Drive compliance, manage submissions, and collaborate with cross-functional teams to ensure product lifecycl...

Shape the future of regulatory strategies by leading CMC initiatives for small molecules and biologics, ensuring compliance and successful submissions throughout the product lifecycle while managing a...

Join a team that's shaping regulatory strategies for small molecules and biologics. Lead CMC submissions, manage project milestones, and collaborate with cross-functional teams to ensure compliance an...

Champion regulatory excellence by leading submissions and compliance efforts. Collaborate with cross-functional teams to ensure alignment with FDA and international standards while driving projects to...

Drive global regulatory engagement and influence by creating evidence-based resources, collaborating across teams to enhance regulatory policies, and supporting public health standards worldwide. Impa...

Drive quality excellence by overseeing compliance and CAPA processes, collaborating with cross-functional teams to resolve issues, and implementing continuous improvement initiatives in a dynamic envi...

Support compliance in Quality Control by managing investigations and quality records. Collaborate on metrics reporting and ensure adherence to regulatory standards for GMP manufacturing of biological...

Lead the charge in regulatory consulting by delivering expert advice and strategies for clients navigating US, EU, and UK regulations. Manage projects independently, build client relationships, and me...

Join a dynamic team to oversee regulatory labeling operations, ensuring compliance and quality in pharmaceutical labeling processes. Collaborate with cross-functional teams to drive successful project...

Lead the charge in regulatory operations by overseeing submissions to the FDA, ensuring compliance with regulations, and driving analytics to enhance operational performance while collaborating with c...

Advance regulatory strategies for medical devices, managing submissions and ensuring compliance throughout the product lifecycle. Collaborate with project teams and regulatory bodies on 510(k)s, PMAs...

Engage with cross-functional teams to drive regulatory strategies and submissions for medical devices while ensuring compliance through the product lifecycle, including ongoing collaboration with dome...

Transform regulatory strategies by providing CMC expertise to support product development and compliance in a dynamic pharmaceutical environment, ensuring quality and adherence to global standards thr...

Champion regulatory excellence by guiding product development teams, ensuring compliance with global standards, and fostering strong stakeholder relationships to drive business success...

Join a dynamic team to manage regulatory compliance and permitting for acid gas injection and underground storage operations, ensuring adherence to state regulations while collaborating with cross-fun...

Lead the charge in regulatory compliance and permitting for acid gas injection and underground storage operations, ensuring adherence to state regulations while collaborating with cross-functional tea...

Lead regulatory activities for global medical device registrations and submissions. Collaborate with cross-functional teams to ensure compliance with FDA and international regulations, managing docume...

Champion complex regulatory strategies for combination products, leading cross-functional teams to navigate global requirements and ensure successful development, registration, and lifecycle managemen...

Transform regulatory strategies by leading complex combination product initiatives. Collaborate with cross-functional teams to ensure compliance and successful lifecycle management of innovative medic...