Senior Regulatory Affairs Consultant
My client is a pre-clinical stage start-up company focused on developing gene editing technologies for the treatment of Duchene muscular dystrophy and other neuromuscular diseases. They are looking for a Senior Regulatory Affairs Consultant to lead regulatory activities for the company’s programs in development. Responsibilities will include the support of Pre-ID meetings, development of regulatory strategies, and execution of eventual filings. This is a remote based position.
Responsibilities:
- Management of all regulatory aspects of the company’s development activities in support of Pre-IND meetings
- Be the key contributor in the design of regulatory strategies and execution of eventual FDA filings
- Contribute to company initiatives related to regulatory affairs operations and strategy
- Work with the project team to identify and develop an optimum regulatory strategy for Pre-IND and IND activities
- Independently interact with regulatory authorities, consultant peers on a daily basis
- Write, review and edit regulatory documents
Knowledge and Skills:
- Minimum PhD or equivalent in immunology or a related discipline required
- Minimum 10+ years in Regulatory Affairs with experience in early through mid-stage development a must
- Experience with US and international management of Pre IND/IND filing activities
- Experience developing and leading regulatory strategies for clinical and pre-clinical programs
- Experience in genetic mutations resulting in neuromuscular/neurodegenerative diseases desirable but not required
- Experience working within pediatric orphan drug indications and solid understanding of regulatory requirements for and experience with submission of applications (IND) in eCTD format
Number of hours worked per week: 20-30 hours a week
Length of Assignment: 6 months
Position Location: Remote