Regulatory & Quality jobs

• Watertown
• $38 to $40 per hour
• Posted 4 days ago

Associate Formulation Scientist Status: 6 month contract Location: onsite in Watertown, MA Hourly rate: $38 to $40 depending on experience Position Summary The individual in this role will be part of an interdisciplinary team supporting pre-clinical and clinical programs through product design, r...

• Lexington
• $260,000-285,000
• Posted 16 days ago

Senior Director, Regulatory Affairs Greater Boston Description:  The Director/Senior Director, Regulatory Affairs is responsible for developing and executing the global regulatory strategy for the programs assigned. Reporting to the Head of Regulatory Affairs, this individual will develop and adv...

• San Diego
• $167,000.00-$241,925.00
• Posted 26 days ago

Responsible for contributing to the strategy and execution of regulatory CMC plans for assigned development and commercial projects leading to successful preparation and approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner focused on development for biologics, small molecu...

• San Francisco
• $215,000 - $280,000
• Posted 2 months ago

  Position Description: The Director of Regulatory Affairs will serve as the global regulatory lead (GRL) on several immunology programs and will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of tha...

• Boston
• $180,000-215,000
• Posted 3 months ago

The Clinical Project Manager / Sr. Clinical Project Manager (CPM) provides operational leadership of one or more clinical trials from protocol development through clinical study report, and ensure activities are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations,...

• San Diego
• $167,000.00-$241,925.00
• Posted 3 months ago

Serves as the lead reviewer for medical education and commercial advertising and promotional materials for product, disease state, and training/education programs. Leads cross-functional collaboration to ensure appropriate reviews take place and timely submissions are made to OPDP. Work closely w...

• Waltham
• $200,00-$225,000
• Posted 3 months ago

Director, Clinical Quality Assurance, Pharmacovigilance The Director of CQA-PV is the supervisor of the Clinical Quality Assurance Department with responsibilities for quality oversight of the Post Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations that contribute to the ...

• Cranbury
• 285000
• Posted 3 months ago

Senior Director, Global Regulatory Lead    Our client is growing, rare genetic disease company based in the Princeton area, dedicated to developing treatments across hematology, cardiology, and other undisclosed diseases. With a pipeline of multiple late-stage programs and BLAs slated for the com...

• San Carlos
• TBA. Estimated range: 200-235K base
• Posted 4 months ago

Director, Regulatory Affairs Location: San Mateo, CA Position Overview: The Director of Regulatory Affairs will lead global regulatory activities with a focus on clinical filings. This role involves guiding regulatory strategy, managing submissions, supporting clinical trial applications, and ens...

• Boston
• $180,000-$230,000
• Posted 5 months ago

AD/Director, Regulatory Operations & Affairs About the Role We are seeking a highly skilled, and experienced AD/Director of Regulatory to join our growing clinical team. This hands-on position will be responsible for overseeing and managing all global regulatory activities to ensure compliance wi...

• Lexington
• $130,000-$140,000
• Posted 8 months ago

Manager, Clinical Supply Chain Management Reporting to the Director, Clinical Supply Chain the Manager, Clinical Supply Chain Management will be responsible for establishing and managing the end to end clinical supply for clinical studies/programs in various phases. Successful candidates will pos...