Location: Remote (client is based in greater Boston)
Duration: 3 months will possibility of extension
A Black Diamond client is looking for a Regulatory Affairs Manager who comes from a hands-on operational background to support their 12 person team. They have several regulatory activities happening. 30% of the job is being a liaison who can interface with their CRO and them (working with CRO’s is a strong PLUS and will be considered before candidates who lack this experience) and 70% of the job will be supporting and contributing to the regulatory team regarding regulatory documents, submissions, and working on SOPs that support the clinical trials. This individual should be strong and well versed with eCTD (electronic common technical documents) and has previously worked on IND submissions to the FDA. A power player would also have experience working on NDA/CTA/MAA’s as they anticipate having more things come about over the course of the next year or so. They also have legacy products from another company so this individual will be responsible for compiling the documents in eCTD as the documents came distorted with gaps in them. They have an intern coming from Northeastern and would appreciate this person guiding/training/mentoring that individual in the regulatory space. This role requires an individual who has excellent communication skills and who is self sufficient/self motivated and needs little to no guidance, ready to roll up their sleeves and get to work and be the senior VP of Regulatory’s “right hand (wo)man.” They would like someone who understands a small company mindset, but large pharma will be considered as well. Rare disease is preferred for the therapeutic space, but not required.
***East Coast candidates preferred***
JOB ID: 225937