We are looking for a CMC Regulatory Change Control Support Specialist, working in the Healthcare Systems & Services industry in Waltham, Massachusetts, United States.
Interact with Regulatory CMC leads to ensure accurate understanding the scope of the change controls and the strategy of regulatory submissions
Responsible for gathering and reporting country level assessments to ensure they are completed accordingly e.g. target dates
Responsible for gathering overall impact for Change Controls from the Reg CMC lead and entering the impact into the Quality Management System
The pay range we are offering is 30 to 35 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
A minimum of 3 years in the pharmaceutical industry including a minimum 1 year of experience within regulatory CMC Biologics preferred
Some direct experience in interfacing with relevant regulatory authorities.
Some Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Some knowledge and understanding of applicable regulations.
Some experience with Change Control and Regulatory systems.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.