Do you have previous experience in regulatory affairs – ideally within generic pharmaceuticals? Are you interested in stepping into a more senior position with a wider remit of responsibilities?
Invenia Group is currently partnered with an already established, but further expanding generic pharmaceutical company based in New Jersey, which is seeking a Senior Associate in Regulatory Affairs to join its growing team. This professional will focus on the preparation and review of regulatory submissions documents with/without supervision depending on seniority.
Role responsibilities:
If successful, you will be tasked with the review and submission of all US regulatory ANDAs submissions, any amendments, supplements, annual reports, etc, as well as review and provision of feedback on change controls for CMOs and internal manufacturing sites. You will ensure the complete accuracy of the review which assures FDA compliance, all within a timely manner.
What we are looking for:
We are looking for someone with a life science degree and previous experience (at least 1 year+) within regulatory affairs in a generic pharmaceutical environment. This individual will have effective communication skills, an ability to multitask and collaborate with other functions and be proficient in the Microsoft Word package/Adobe.
This is a great opportunity to join a growing company and a personable regulatory affairs department and further expand your abilities.
If you are interested in proceeding with this opportunity, please apply to discuss the position in more detail.