A cutting edge pharmaceutical company that deals with life-threatening rare diseases is currently searching for a Senior Associate - Regulatory Affairs to join their team. The 6+ month contract role with possible extensions would play a key role in regulatory strategies for preparation of HA interactions.
Responsibilities
- Collaborate with CROs
- Help maintain IND/CTAs
- Go over SOPs and related documents
- Guarantee that submission time lines are met
- Assist with the preparation of HA submission packages
- Compile relevant materials (Annual Reports, Protocols, Briefing Books, etc.) and complete regulatory documents
Qualifications
- 6+ years with a Bachelor's
- 4+ years with a Masters, or;
- 2+ years with a PhD in life sciences (or related field)
- Great strategic thinking skills
- Experience with IND/CTAs
Competitive pay, full benefits, and a great opportunity to work with a prestigious pharmaceutical company.