Regulatory Affairs Specialist Jobs in Summit, NJ

Empower global product strategy in Regulatory Affairs, leading teams to navigate complex regulations for therapeutic developments in inflammation and rare diseases. Drive global registration and lifec...

Engineer innovative CMC regulatory strategies to ensure compliance across product lifecycles. Collaborate with cross-functional teams to deliver high-quality submissions and expert guidance while main...

Join a team that's driving CMC regulatory strategies globally, ensuring compliance and integrity. Partner across functions to deliver high-quality submissions and navigate regulatory challenges effect...

Empower your CMC expertise to drive global regulatory strategy and submissions, ensuring compliance during drug development and commercialization, while collaborating across regions to enhance patient...

Join a team that's driving global regulatory compliance and product stewardship initiatives, ensuring alignment with commercial strategies and effective management of risks to support business growth...

Accelerate your impact by winning high-value, complex opportunities through innovative workflow design and technical expertise, while shaping market direction and influencing strategic commercial deci...

Champion innovative regulatory strategies in a dynamic, global team dedicated to pioneering drug development. Leverage your expertise to navigate complex issues and deliver high-potential therapies ef...

Engage in critical monitoring tasks for diverse clinical studies, ensuring compliance and quality while communicating effectively with project teams and site staff to meet recruitment targets and main...

Drive global regulatory strategies for product approvals and lifecycle management. Lead cross-functional teams, ensuring compliance and mitigating risks, while mentoring team members and influencing r...

Engage in shaping global regulatory strategies to secure market approval for innovative products. Lead cross-functional teams to mitigate risks, ensure compliance, and drive strategic initiatives thro...

Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...

Drive data transformation into actionable insights supporting product quality and patient safety. Leverage statistical analysis, AI, and analytics to proactively identify trends, enhance decision-maki...

Lead commissioning, qualification, and validation efforts for GMP facilities and systems in cell therapy manufacturing, ensuring compliance and implementing risk-based strategies aligned with industry...

Lead and enhance commissioning, qualification, and validation processes for GMP cell therapy manufacturing, ensuring compliance and best practices are met while driving proactive issue resolution and...

Empower the development of CMC regulatory strategies for small molecule drugs. Lead global submissions and provide expert recommendations for meeting regulatory requirements, ensuring high-quality com...

Join us to lead global regulatory strategies in the Vaccines and Infectious Disease area, ensuring compliance and optimal approval timelines. Collaborate cross-functionally, directly engage with regul...

Lead the development of global CMC regulatory strategies and manage eCTD submissions for investigational and marketed products, collaborating with cross-functional teams to support lifecycle managemen...

Unlock innovative solutions as a Data Steward, driving data governance and integrity initiatives across cross-functional teams to enhance insights and streamline processes in a fast-paced digital tran...

Shape the future of legislative advocacy by developing strategies and building strong relationships to navigate complex political landscapes and ensure business goals are met, while leading critical d...

Unlock your potential by driving advocacy strategies within complex legislative environments while fostering key relationships to influence policy and business growth. Lead initiatives that empower en...

Elevate regulatory excellence by leading cluster strategies, ensuring compliant market access, and fostering collaborative partnerships. Drive impactful outcomes through a cohesive approach to regulat...

Lead the charge in global regulatory strategy execution, optimizing processes and ensuring compliance with health authority requirements. Drive submission planning and tracking while leveraging Veeva...

Join a team that drives excellence in regulatory document publishing and management. Oversee the formatting and submission process while ensuring compliance with industry standards, fostering collabor...

Innovate regulatory strategies for promotional initiatives, ensuring compliance with FDA guidelines. Collaborate with diverse teams to assess risks and deliver impactful solutions in the pharmaceutica...

Elevate your career by joining a top regulatory practice specializing in insurance and securities. Collaborate with experts and gain hands-on experience to develop leading expertise in a dynamic legal...