Senior Regulatory Affairs Manager

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About the job

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:

  • Provision and maintenance of the company’s NDC number list – review of proposed new product labeling for FDA compliance requirements
  • Provision of information and documents from a regulatory perspective to the Sales / Marketing teams; Supporting the Pharmacovigilance Team
  • Acting as the first point of contact for communication with the Agency as a US agent

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.