Director, Regulatory Affairs Jobs in Cambridge, MA

Lead transformative efforts in oral drug product development, ensuring manufacturability and readiness from early development to commercialization while mentoring scientists and driving technology adv...

Shape the future of healthcare by leading strategic projects, managing teams, and delivering impactful solutions in market access and reimbursement. Collaborate closely with clients to drive innovatio...

Shape the future of drug safety by leading pharmacovigilance efforts, ensuring compliance, and managing safety data to inform pivotal decision-making across global product lifecycles...

Lead strategic bioanalytical efforts to support innovative peptide therapeutics, ensuring high-quality data generation across all development stages. Collaborate across teams to drive efficient progra...

Champion the regulatory framework for advertising by reviewing and approving promotional materials. Collaborate with stakeholders to ensure compliance and guide product development while maintaining s...

Join us to lead strategic and operational clinical development efforts, ensuring compliance and collaboration across multiple functions. Drive the execution of clinical trials and enhance organization...

Lead the charge in strategic clinical operations, overseeing development and execution of programs across multiple disciplines to align with corporate objectives and ensure operational excellence in a...

Transform quality management systems and GxP compliance by providing strategic, hands-on leadership to ensure robust, compliant systems. Collaborate across teams to enhance processes and maintain insp...

Reimagine clinical contract negotiations by joining a dynamic team committed to efficiency and compliance. Support various contract types and ensure streamlined processes while interfacing with stakeh...

Join a dynamic team to ensure compliance and regulatory excellence in documentation and submissions. Collaborate on vital regulatory affairs projects while engaging with key regulatory agencies to fac...

Champion innovative access solutions by driving relationships with national payers and clients. Lead strategies that maximize patient access and profitability while collaborating with cross-functional...

Engage in managing quality assurance systems for clinical and medical affairs, ensuring compliance with global regulations. Collaborate cross-functionally to drive oversight and improve practices in p...

Engage with key stakeholders to develop and lead strategic policy initiatives that drive Travere Therapeutics' mission in rare disease advocacy and legislation. Collaborate cross-functionally to influ...

Join us in building a comprehensive compliance program that drives integrity and accountability as we transition into a commercial organization, ensuring adherence to regulatory standards and supporti...

Accelerate progress at community-based urology practices by developing impactful engagement strategies with key stakeholders, ensuring collaboration to enhance patient access and optimize adoption of...

Manage key regulatory functions, guiding compliance in PBM, pharmacy, and healthcare technology. Advise on state and federal obligations, and translate regulations into practical strategies for busine...

Manage GMP quality assurance activities to ensure compliance, support clinical development, and promote a culture of quality in innovative product advancement. Collaborate with internal teams and exte...

Engage with us to lead global CMC regulatory strategies for biologics, ensuring high-quality submissions and fostering collaborative interactions with Health Authorities while implementing AI-enhanced...

Unlock potential by leading trade strategy development and distribution optimization for a pioneering biopharmaceutical. Drive partnerships, manage logistics, and ensure compliance to enhance product...

Unlock potential by leading regional regulatory strategies for innovative products. Collaborate effectively with global teams, ensuring compliance and fostering strong relationships with health author...

Shape the future of drug development by leading Drug Product activities, fostering collaboration across teams, and managing external partners to drive successful product advancement in alignment with...

Join a dynamic team driving legal operations and governance, ensuring support for Executive Leadership and the Board. Lead initiatives, enhance processes, and foster cross-functional collaboration for...

Champion impactful communications strategies to elevate lupus awareness, engage patients, and collaborate across teams, driving measurable business outcomes and enhancing corporate reputation in the h...

Drive impactful communications strategies for lupus initiatives, enhancing stakeholder engagement and awareness. Lead cross-functional collaboration to translate complex medical information and suppor...

Transform chronic weight management strategies on a global scale, driving evidence generation and medical communication while leading cross-functional collaboration to deliver impactful healthcare sol...