Director, Regulatory Affairs Jobs in Waltham, MA

Drive global regulatory strategy for marketed products, ensuring compliance with local regulations. Collaborate across functions to support submissions and maintain market access, while guiding teams...

Transform global regulatory processes by leading approvals, strategizing submissions, and ensuring compliance for medical devices across diverse markets while collaborating with teams and serving as a...

Oversee the healthcare compliance program, ensuring adherence to regulations and policies while conducting investigations, training, and audits to mitigate risks and enhance transparency across client...

Join a team that's shaping the future of regulatory strategy in biopharma. Lead cross-functional collaborations, guide regulatory submissions, and drive successful agency engagements for groundbreakin...

Lead the charge in advancing clinical operations by developing strategies and overseeing complex clinical programs. Collaborate with diverse teams to ensure effective delivery, adherence to regulation...

Lead the charge in ensuring quality compliance by executing risk-based audits, assessing adherence to GxP regulations, and driving continuous improvement while partnering with cross-functional teams t...

Join a dynamic team as a Regulatory CMC Senior Manager, driving global regulatory strategies, lifecycle management, and cross-functional collaboration to advance innovative products in a fast-paced en...

Join a team that's shaping the future of medical strategy for a key asset. Leverage deep therapeutic expertise, cultivate strategic partnerships, and drive compliance while aligning cross-functional t...

Transform the future of patient safety by establishing robust procedures and policies that align with global Pharmacovigilance regulations. Collaborate cross-functionally to ensure compliance and effi...

Shape the future of regulatory strategy for critical products. Leverage your expertise to oversee local regulatory submissions and ensure compliance while collaborating with global teams to optimize p...

Lead nonclinical safety strategies in Oncology, guiding pivotal clinical trials and regulatory submissions. Collaborate globally to ensure scientific excellence and build trust across diverse teams, i...

Unlock your potential as a key player in advertising and promotion compliance, guiding regulatory strategies and collaborating across teams to enhance product success in the pharmaceutical sector. Rea...

Strategize and lead regulatory strategies for advertising and promotions, ensuring compliance and effectiveness. Work cross-functionally to maximize product impact and navigate complex medical environ...

Empower regulatory compliance within the 340B Program by interpreting complex regulations, advising internal teams, and ensuring operational readiness. Drive impactful educational initiatives and coll...

Lead oversight of pharmacovigilance operations, ensuring compliance with regulations and managing vendor deliverables. Drive ICSR quality and CAPA processes while mentoring staff and monitoring perfor...

Lead strategic medical initiatives for Multiple System Atrophy, guiding cross-functional teams in the U.S. medical strategy, scientific communication, and external engagement, while ensuring complianc...

Optimize regulatory strategies for pharmaceutical advertising and promotion, providing leadership in decision-making and collaboration across functions. Ensure compliance with FDA regulations and ment...

Join a team that drives EHS strategy globally, ensuring regulatory compliance, risk management, and continuous improvement while fostering a proactive culture across all manufacturing locations...

Join our dynamic Regulatory Affairs team to drive global regulatory strategy, manage submission planning, and engage health authorities, contributing to innovative oncology programs in a fast-paced, c...

Shape the future of environmental safety and health by leading global initiatives that drive compliance, risk reduction, and a proactive culture. Collaborate with leaders across functions to sustain e...

Play a key role in developing and implementing global EHS strategies that ensure compliance, reduce risk, and protect the environment. Lead a proactive safety culture while partnering with various sta...

Pioneer innovative scientific strategies in hemostasis, translating evidence into commercialization and stakeholder engagement. Build relationships with experts, support training, and align functions...

Drive product quality and customer confidence by leading a team in quality investigations and continuous improvement initiatives, while fostering collaboration and accountability across functions to a...

Join a team that leads Clinical Pharmacology strategies, driving late-stage development and regulatory interactions for transplant programs to ensure effective drug approval and lifecycle management...

Lead the charge in ensuring regulatory compliance for promotional materials. Collaborate cross-functionally to interpret FDA guidelines, mentor staff, and drive effective strategies in advertising for...