Regulatory & Quality jobs

• Fishers
• $170,000-195,000
• Posted about 19 hours ago

n//a

• Lexington
• $170,000 - $205,00
• Posted 10 days ago

Associate Director, Regulatory Affairs CMC Job Summary: The Associate Director, Regulatory Affairs CMC will develop and execute global regulatory CMC strategies to support drug development programs across all phases of the product lifecycle, from IND/IMPD through NDA/MAA submissions and post-appr...

• Gaithersburg
• Commensurate with experience
• Posted 10 days ago

Manager, Quality Assurance and Quality Control Position Overview: This role is a key position within the organization, contributing to setting short- and medium-term goals related to quality assurance. The Manager of Quality Assurance & Quality Control is responsible for overseeing and maintainin...

• Cranbury
• 265000
• Posted 11 days ago

Senior Director, Clinical Quality Assurance Join our team dedicated to curing rare diseases! We value our team members' growth and well-being as much as our scientific progress. We seek collaborative, hands-on individuals passionate about making a difference for patients. This is an opportunity t...

• Boston
• 200,000-225,000 a year
• Posted 26 days ago

Job Title: Director Regulatory Affairs Strategy      Location:  Remote OR Menlo Park, CA OR Waltham, MA Position Overview: The Director Regulatory Affairs Strategy provides global regulatory oversight and project leadership of assigned development products and reports to the Vice President Regula...

• San Francisco
• $290,000 - $350,000
• Posted 26 days ago

Reporting to the Senior Vice President of Global Regulatory Affairs and Quality Assurance, this position will serve as an in-house champion on GxP compliance as well as establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international ...

• San Francisco
• $250,000 - $300,000
• Posted 26 days ago

ESSENTIAL DUTIES AND RESPONSIBILITIES Support the preparation and implementation of regulatory strategies, for new drug Lead Clinical Quality oversight, including creation and revision of SOPs and training programs for GCP compliance Ensure involvement of Quality from early phases of development ...

• San Francisco
• $255,000 - $300,000
• Posted 26 days ago

POSITION SUMMARY Guide the overall CMC regulatory strategy globally and manage the required resources to meet an aggressive regulatory submission schedule, ensuring the effective fulfillment of company goals and objectives.  This will be an individual contributor role reporting to Sr. VP, Regulat...

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

Responsible for contributing to the strategy and execution of regulatory CMC plans for emerging gene therapy portfolio. Will require relocation to Southern California with primarily onsite working policy. Your Role Responsible for the regulatory CMC strategy and execution for assigned commercial ...

• San Diego
• $167,000.00-$241,925.00
• Posted 5 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 5 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 ...

• Boston
• $180,000-$230,000
• Posted 7 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 10 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...