Regulatory Affairs Operations Lead
My client is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. They have retained us to fill a growth opportunity for a Regulatory Operations Lead to join their science driven, patient focused culture. In this newly created role you will be responsible for driving direction and leadership of Regulatory Affairs Operations Department. The hiring manager is the process of setting up interviews, below is a link that will allow you to schedule a time for us to discuss this career advancing opportunity in greater detail.
Responsibilities:
- Drive and manage all aspects of planning and publishing submissions and/or submission components including all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, production (paper and electronic), and archiving (paper and electronic), as applicable
- Responsible for maintaining and tracking of regulatory milestones and deliverables
- Ensure excellence in the global regulatory support to projects/products throughout lifecycle management
- Interpret local and global electronic submission regulations and prepares interpretative analyses of key regulatory guidance documents related to submissions
Knowledge and Skills:
- Minimum BS in a scientific discipline
- Minimum 7-10 years of regulatory submission experience
- Must have experience with submissions in the EU
- Must have experience with implementation of ECTD
- Experience with submissions and technology required
- Experience with BLA and marketing authorization application of submissions outside of the US
- Hands-on experience and extensive knowledge of IND/BLA/eCTD and other electronic requirements and guidelines required