Senior Regulatory Affairs Specialist Jobs

Lead regulatory initiatives by driving submission activities and collaborating with cross-functional teams to ensure compliance and support global registration strategies for late-stage development pr...

Shape the future of regulatory affairs by driving strategies for late-stage development programs. Collaborate across teams to ensure compliance, manage submissions, and support critical milestones in...

Shape the future of global medical device compliance by leading regulatory intelligence efforts. Collaborate cross-functionally to ensure adherence to evolving regulations and drive market access for...

Drive regulatory excellence by managing global submissions and overseeing interactions with health authorities, ensuring compliance throughout the product lifecycle for various therapeutic areas, prim...

Drive regulatory excellence by managing global submissions and ensuring compliance. Collaborate with cross-functional teams to navigate health authority engagements and support strategic submissions a...

Unlock potential by managing global regulatory submissions and strategies, ensuring alignment with health authority requirements. Collaborate across teams to drive innovative treatments from concept t...

Lead the charge in executing global regulatory CMC strategies for small molecules. Collaborate with cross-functional teams to ensure compliance and contribute to the preparation of regulatory submissi...

Join our team to drive global regulatory CMC strategies for small molecules. You'll manage submissions, collaborate with cross-functional teams, and ensure compliance with global regulatory standards...

Lead bioassay research and development for biotechnology products, focusing on assay validation and implementation. Collaborate on data-driven regulatory policies while managing research projects and...

Join a team that's dedicated to navigating international regulatory landscapes while ensuring compliance for innovative medical devices. Collaborate across departments to secure timely product approva...

Take ownership of regulatory strategies and policies for medical devices, collaborating with cross-functional teams to ensure compliance and optimize operations in a dynamic healthcare environment. Ma...

Lead the charge in ensuring compliance and quality systems across facilities, utilities, and processes for the AH division, driving strategic oversight and validation efforts to achieve operational ex...

Shape quality excellence by leading compliance in raw materials and batch records. Collaborate across teams to ensure timely resolution of issues and uphold industry standards through effective docume...

Oversee the management of regulatory documents to ensure compliance with FDA and internal standards. This role involves data entry, documentation management, and support during regulatory audits and s...

Shape the future of pharmaceutical quality research by conducting scientific analyses to evaluate protein drug stability and develop predictive methodologies that enhance regulatory decision-making fo...

Engage in advanced data analytics to guide regulatory submissions for reduced risk products. Own and improve analytical data processes, ensuring integrity and compliance within a dynamic FDA-regulated...

Lead the charge in developing and implementing regulatory strategies for compliance with nuclear safety standards, overseeing a team while ensuring effective communication with regulatory bodies and m...

Transform the regulatory landscape by shaping product communications and ensuring compliance with FDA regulations. Guide promotional reviews, mentor team members, and navigate evolving regulatory chal...

Oversee innovative regulatory strategies to support transformative clinical programs. Collaborate with cross-functional teams to ensure the preparation of high-quality regulatory submissions while dri...

Lead the charge in promoting safety excellence in data center construction by mentoring teams, conducting safety audits, and ensuring compliance with regulations while fostering a robust safety cultur...

Transform regulatory processes by leading 510(k) and PMA submissions, ensuring compliance with FDA guidelines, and fostering collaboration among cross-functional teams to drive timely product approval...

Drive global regulatory strategies for Phase 2/3 clinical programs, ensuring alignment with health authority requirements. Collaborate across functions to navigate complex regulatory landscapes and le...

Manage the governance of the enterprise-wide specimen collection kit program. Oversee quality assurance initiatives, ensure regulatory compliance, and implement a robust Quality Management System to e...

Empower your career by leading global regulatory strategies for late-stage clinical programs, ensuring compliance and driving interaction with health authorities to achieve successful product commerci...

Transform the validation process in a dynamic sterile injectables environment. This role requires expertise in qualification activities, supporting capital projects, and collaborating cross-functional...