Regulatory Affairs Manager Jobs in Billerica, MA

Execute regulatory strategies for global product approvals, guiding teams through the lifecycle and managing submissions. Foster agency relationships, maintain compliance, and lead audits while mentor...

Champion regulatory strategies and compliance for innovative urology solutions, supporting product development and external partnerships across global markets, enhancing patient care through collabora...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Serve as a strategic leader in Clinical Quality Assurance, overseeing global Pharmacovigilance Quality Systems. Drive continuous improvement initiatives and provide compliance oversight, partnering wi...

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...

Take ownership of a critical pipeline initiative, driving qualified study opportunities via strategic account-based marketing and cross-functional collaboration, focused on delivering real-world evide...

Unlock potential by shaping global regulatory strategies and driving advocacy initiatives. Collaborate across teams to manage regulatory risks, assess opportunities, and provide strategic insights tha...

Lead regulatory strategies for US promotional materials, ensuring compliance with FDA standards while collaborating across departments. Provide expertise for complex products, navigating regulatory la...

Transform regulatory strategy and operations across CMC and clinical activities, leading a high-performing team to ensure compliance and successful product approvals from development through post-appr...

Lead the charge in developing regulatory strategies for managed access programs, guiding clients through global pathways, and enhancing patient access to investigational therapies through strategic in...

Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...

Unlock your potential by leading global quality compliance initiatives, coordinating audits, training programs, and ensuring regulatory adherence to safeguard product integrity and drive organizationa...

Transform regulatory affairs by leading global strategy for oncology programs. Partner cross-functionally to navigate IND submissions and health authority interactions, ensuring successful Phase 1 and...

Unlock potential by leading global regulatory CMC activities, developing strategies for product lifecycle management, and collaborating across teams to ensure successful agency submissions. Drive tran...

Unlock potential by leading regulatory compliance for advertising and promotional materials, guiding cross-functional teams in strategic initiatives, and ensuring adherence to industry standards and F...

Shape the future of product communication by delivering expert regulatory guidance, collaborating across departments, and ensuring compliance with FDA regulations to support brand initiatives and prom...

Take ownership of regulatory advertising and promotion strategies, ensuring compliance with FDA requirements and alignment with corporate goals. Lead cross-functional collaborations in a fast-paced, d...

Pioneer regulatory CMC strategies while leading cross-functional teams in the pharmaceutical industry. This role will focus on lifecycle management and submissions across US, CA, and EU markets, ensur...

Advance regulatory strategy and submissions for CMC in pharmaceuticals, collaborating with cross-functional teams to ensure compliance with FDA, EMA, and ICH standards while overseeing product lifecyc...

Lead the charge in developing global regulatory strategies for innovative immunology programs. Drive product approval processes, ensuring compliance and optimal labeling while managing complex project...

Unlock packaging compliance excellence by leading cross-functional strategies to ensure global adherence to evolving regulations. Drive sustainability initiatives while championing innovative solution...

Oversee regulatory CMC strategies for biological projects, ensuring compliance and timely delivery of milestones. Lead cross-functional teams and manage documentation for global submissions throughout...

Innovate global CMC regulatory strategies and submissions for biological products. Ensure high-quality compliance with US and Canadian regulations, while collaborating cross-functionally to manage lif...

Lead the charge in CMC regulatory activities for investigational and commercial products, ensuring compliance and strategic direction across multiple complex projects while mentoring staff and influen...

Lead impactful QA/RA initiatives to enhance compliance and quality systems for medical device clients. Drive innovative strategies using AI technology to shape the future of regulatory affairs and ens...