Senior Regulatory Affairs Specialist Jobs

Advance compliance and quality in healthcare by leading regulatory initiatives, conducting assessments, and collaborating with clinical leaders to ensure continuous readiness and adherence to accredit...

Drive quality assurance initiatives by auditing computer system validations and documentation. Collaborate with cross-functional teams to ensure compliance with regulatory standards while managing con...

Transform healthcare by ensuring compliance in medical device reporting. Collaborate with cross-functional teams to review and document medical events, driving quality and regulatory excellence in our...

Drive regulatory strategies and support submissions across MENA markets, ensuring compliance and timely market access while collaborating with teams and representatives for effective approvals and pro...

Join a team that's responsible for regulatory strategies to secure product approvals across MENA markets. Collaborate with cross-functional teams to ensure timely access while supporting compliance an...

Innovate regulatory operations by managing submission preparation and execution, ensuring compliance with FDA and ICH standards. Collaborate cross-functionally to support complex filings and maintain...

Help us shape the future of medical device regulation by providing expert guidance, ensuring compliance, and collaborating across teams to support product development and marketing initiatives in a dy...

Optimize the PARC process by managing advertising material reviews, ensuring compliance with regulatory standards, and facilitating effective communication among team members to support timely approva...

Unlock potential by leading CMC regulatory strategies for biologics, ensuring compliance and collaboration across teams. Drive submissions and post-market activities while enhancing regulatory process...

Lead regulatory strategies for biologics, ensuring compliance and collaboration across teams. Drive CMC development, submissions, and post-market activities while enhancing processes and aligning stak...

Join a team that's committed to driving innovative regulatory projects, ensuring compliance, and collaborating with cross-functional teams to secure timely submissions and approvals for products in th...

Grow your career with a dynamic team driving global combination product development and regulatory submissions. Collaborate across functions to ensure compliance and support innovative solutions that...

Elevate your career by supporting global combination product development and regulatory submissions. Collaborate with cross-functional teams to ensure compliance and drive innovation in a fast-paced...

Drive global combination product development and regulatory submissions, collaborating with cross-functional teams to ensure compliance and support post-market activities in a fast-paced, science-driv...

Drive project management efforts for validation and qualification activities within Quality Control. Collaborate across teams to ensure timely execution and contribute to continuous improvement in a d...

Lead the charge in developing regulatory strategies for medical products, ensuring compliance with FDA standards. Collaborate with teams to navigate the product lifecycle and support submissions for d...

Join a team that's shaping the future of medical products by developing regulatory strategies, preparing submissions, and advising on compliance throughout the product lifecycle. Collaborate with expe...

Advance regulatory strategies by collaborating with cross-functional teams to support clinical studies and submissions, ensuring compliance with health authority requirements and maintaining up-to-dat...

Lead the charge in global regulatory submissions, managing U.S. INDs and ex-U.S. CTAs. Collaborate cross-functionally to develop strategies, ensure compliance, and drive timely approvals in a fast-pac...

Join a team that's shaping global regulatory strategies, managing U.S. and ex-U.S. submissions, and ensuring compliance with FDA and EU regulations. Leverage your expertise to drive impactful regulato...

Unlock potential by overseeing regulatory submissions and compliance across multiple countries. Collaborate with project teams to ensure timely approvals and maintain up-to-date knowledge of local reg...

Transform the future of regulatory affairs by leading global strategies for IVD and LDT products. Drive compliance, oversee submissions, and guide cross-functional teams to ensure successful product l...

Shape the future of medical products by serving as a Senior Regulatory SME, guiding the development, submission, and compliance of military drugs, biologics, and medical devices. Collaborate cross-fun...

Support compliance and quality management systems by leading document control, CAPA investigations, and customer complaint resolutions. Collaborate across departments to enhance quality assurance and...

Champion the global CMC regulatory strategy for a pivotal HCM program, ensuring compliance from Phase 3 through launch. Collaborate with cross-functional teams to build robust regulatory processes and...