Background : The client is a pharmaceutical company that has an opening in their regulatory CMC division due to a full time employee leaving the company.
They are looking to fill the void with a CMC regulatory affairs SME who has experience with Oligonucleotides. The consultant being brought on is expected to work with CMC modules 2 and 3 and will be part time to start, working 20-
40 hours per week which will increase to a full time 40 hour per week workload after one to two months.
Project : The project will be primarily a support role reporting to the Vice President of Regulatory Affairs. They will be expected to come in and be able to work within the regulatory affairs CMC department.
The roles and responsibilities will include hands on writing of modules 2 and 3, mentoring younger team members, and providing strategy when needed.
A major component to this role is having experience with Oligonucleotides.
Required : CMC Regulatory Affairs