Regulatory Affairs Manager Jobs

Join a dynamic team to develop and execute regulatory strategies for market access across US, Canada, EU, and international markets. Collaborate on NPD and sustain activities while maintaining complia...

Drive quality assurance initiatives to maintain compliance and validation for both sterile and non-sterile pharmaceutical manufacturing processes, ensuring adherence to corporate and regulatory standa...

Oversee regulatory guidance for product development, ensuring compliance with domestic and international regulations to support timely market approvals and ongoing device maintenance across multiple r...

Develop innovative global regulatory strategies for medical devices, ensuring compliance throughout the product lifecycle while collaborating with cross-functional teams and regulatory agencies to sup...

Support cross-functional teams by providing regulatory guidance for IVD product development, developing strategies, and conducting risk assessments to ensure compliance with FDA and EU regulations for...

Innovate in personalized healthcare as a Senior Regulatory Affairs Specialist, guiding cross-functional teams on compliance for Class II medical devices. Your strategic insights will shape product dev...

Advance your career by developing global regulatory strategies for medical devices, managing submissions, and guiding cross-functional teams to ensure compliance while fostering strong relationships w...

Help us develop and execute global regulatory CMC strategies for investigational products while managing submissions and ensuring compliance with health authority requirements across cross-functional...

Accelerate progress at the forefront of regulatory affairs, providing strategic insights to guide product development and compliance. Collaborate cross-functionally to support global market access and...

Lead the charge in driving CQV activities for pharmaceutical manufacturing projects. Ensure compliance with FDA and GMP standards while overseeing project schedules and budgets across various location...

Lead commissioning, qualification, and validation projects in pharmaceutical manufacturing. Manage cross-functional teams and ensure compliance with regulatory standards. Travel is required to various...

Champion the global regulatory strategy for complex CGT products, driving approval pathways and guiding cross-functional teams. Leverage your expertise in oncology and cell therapy to influence stakeh...

Empower quality assurance and inspection processes, ensuring compliance with FAA regulations while leading a dedicated team to uphold operational excellence in aviation maintenance and safety standard...

Optimize compliance and support quality standards by managing CMO interactions, ensuring accurate submissions, and addressing license non-compliances effectively alongside cross-functional teams. Driv...

Unlock potential by leading global site activation for complex clinical trials. Drive strategy, manage cross-functional partnerships, and ensure compliance while fostering your team's growth in a fast...

Drive the global activation of clinical trial sites, ensuring compliance and efficiency. Collaborate with cross-functional teams to mitigate risks, monitor performance, and lead a team in executing st...

Shape the future of regulatory excellence by managing global submissions, ensuring compliance across the drug development lifecycle, and collaborating across teams to facilitate strong health authorit...

Shape the future of regulatory strategy and execution, driving high-quality submissions and interactions with global health authorities throughout the drug development lifecycle, ensuring adherence to...

Champion global regulatory activities, ensuring high-quality submissions and strategic partnerships. Support lifecycle management across late-stage development, driving compliance with U.S. and intern...

Drive the US regulatory strategy for biosimilars, ensuring compliance and facilitating timely approvals through collaboration across functions. Oversee regulatory submissions and lead interactions wit...

Join our dynamic team as you provide regulatory guidance and develop strategies for the Monarch Platform. Collaborate with cross-functional teams to ensure compliance, manage submissions, and shape th...

Tackle molecular characterization studies and safety reports to support regulatory submissions for GM crops. Collaborate with cross-functional teams and provide expertise in molecular biology, ensurin...

Join a team that's shaping the future of surgical innovation by leading regulatory strategies, guiding product launches, and ensuring compliance across global markets, directly impacting patient care...

Lead regulatory strategy for CAR-T and immunotherapy products, overseeing IND/IMPD and BLA submissions. Guide cross-functional teams, ensuring timely compliance and approvals while developing team mem...

Champion global regulatory strategies for medical devices, ensuring compliance from development through market approval. Collaborate cross-functionally to assess compliance and support international e...