Regulatory Affairs Specialist Jobs in Needham, MA

The Global Regulatory Lead will be responsible for developing and executing global regulatory strategies for products in Sanofi's Immunology and Inflammation portfolio. This role involves leading regu...

The Associate Director of Regulatory Affairs will guide new products into the clinic and ensure compliance with regulatory requirements. This role involves developing global regulatory strategies, lea...

The Manager / Senior Manager, Regulatory Affairs will oversee and manage all global regulatory activities to ensure compliance with applicable laws and guidelines. This role involves collaborating wit...

Coordinate and prepare regulatory submissions to health authorities including FDA, EMA and other national authorities to support clinical trials, including original IND/CTA submissions, new protocols...

The Senior Specialist, Quality Systems and Compliance will provide quality expertise to support the QS&C team in ensuring compliance with US, EU, and ICH requirements for Deciphera's products. This ro...

The Compliance Specialist Principal is responsible for ensuring adherence to cGMPs and market regulations during the packaging operations of finished products and raw materials at Sanofi's Northboroug...

The Head of Global Regulatory Affairs at Affinia Therapeutics will oversee and drive the U.S. and global regulatory strategy. This role involves partnering with cross-functional leadership, providing...

The Quality Assurance Specialist III is responsible for providing advanced-level support in a GxP laboratory services and kitting production environment. Key activities include managing quality system...

The Senior Director of Regulatory Affairs will develop and implement a consolidated regulatory strategy to secure and maintain regulatory approval for assigned products throughout all development phas...

The Senior Product Quality Assurance (PQA) Analyst is responsible for overseeing Quality Assurance activities related to Third Party Manufacturing (TPM) plants. This role includes reviewing manufactur...

The Senior Regulatory Affairs Director, Global Regulatory Strategy at AstraZeneca will oversee the development and implementation of global regulatory strategies for products in the Cell Therapy Immun...

The Executive Director of Regulatory Affairs for Cell Medicine will lead the development and oversight of global regulatory strategies for Regeneron's Cell Medicines, focusing on CAR T therapies. This...

The Director of Global Regulatory Affairs is responsible for interpreting and advising on federal, state, and international regulations related to products and processes. This role involves ensuring c...

The Regulatory Affairs Manager at Freudenberg is responsible for ensuring compliance with chemical laws and regulations, including the management of safety data sheets and hazardous material classific...

The Senior Manager of Regulatory Affairs is responsible for developing regulatory strategies and managing the approval process for data products and platforms in the oncology field. This role involves...

The Quality Audit Specialist at AECOM will oversee quality assurance and control for various transportation projects in the New England and Mid-Atlantic regions. This role involves supervising quality...

The Senior Director of Regulatory Affairs will lead the development and implementation of global regulatory strategies for pipeline drug development programs and marketed products. This role involves...

Participate as a regulatory representative at relevant teams advising on regulatory strategies, submission preparation timelines, processes and requirements...

The Quality Assurance and Regulatory Affairs Manager provides leadership and direction for Quality Assurance and Regulatory Affairs Systems in the Midwest region. The role involves ensuring compliance...

The Senior Quality Assurance Specialist at Lantheus is responsible for providing Quality Assurance expertise to ensure compliance with cGMPs for marketed products and raw materials. This role involves...

The Senior Specialist in GMP QA will support the Quality Assurance department by managing outsourced Contract Manufacturing Organizations (CMOs) and ensuring compliance with GMP standards. Responsibil...

The Global Regulatory Affairs Manager at GSK will develop and execute regulatory strategies for oncology assets, ensuring compliance and timely submission of clinical trial applications. This role inv...

The Associate Director, Regulatory Affairs CMC will develop and execute global regulatory CMC strategies to support drug development programs throughout the product lifecycle. This role involves autho...

The Director, Regulatory Affairs - CMC at Vericel Corporation manages and completes regulatory projects aligned with company goals, focusing on CMC regulatory submissions. The role involves providing...

The Manager of Regulatory Affairs will provide regulatory support and guidance for multiple drug development programs, collaborating closely with regulatory program leads. This role involves managing...