Do you have significant Regulatory Affairs experience within generics? Are you ready for the next step in your career?
Invenia Group is currently partnered with a specialty pharmaceutical company with a generic sterile, oncology, hormones and ophthalmic pipeline. The company is looking for a Senior Manager of Regulatory Affairs who will be responsible for the regulatory functions across sterile products.
Role responsibilities:
If successful, you will be responsible for the pre-submission review of the sterile/non-sterile product ANDA documents – including coordination with project partners/third-party manufacturers to ensure the completeness and timely delivery for submission. You will also be responsible for the following:
What we are looking for:
We are looking for someone with significant experience within Regulatory Affairs in the generics space (6+ years) including some experience in the review of labeling/eCTD Module 1. You should have at least a Bachelor’s degree in a scientific field as well as a great working knowledge of US drug regulatory requirements and be familiar with relevant regulations and guidance.
Flexibility to travel (10%) is also necessary for this role.
If you are interested in proceeding with this opportunity, please apply to find out more.