Senior Regulatory Affairs Associate
Columbus, Ohio
Our client is looking to hire for a Senior Regulatory Affairs Associate who can use their expertise in CMC and Labeling in both pre-approval and post-approval regulatory activities.
The company is a multinational pharmaceutical company that has achieved worldwide success in multiple therapeutic areas; such as cardiovascular, neuroscience, oncology, respiratory, and more. They primarily produce generics and injectables, with over 600 products and a continuously growing catalog to treat a variety of diseases.
The ideal candidate will one who can act a Subject Matter Expert for the R&D department, reviewing both the pre-approval and post-approval application documentation while drawing upon their background in CMC and Labeling. This individual should be comfortable providing regulatory consultation and support to a variety of teams within the company, as well as occasionally mentoring more junior members within their own department.
RESPONSIBILITIES:
* Review and submit regulatory applications for the US Market.
* Provide amendments for ANDAs and NDAs.
* Act as regulatory subject matter expert and work cooperatively across departments at the company.
* Review peer submissions to ensure accuracy and quality.
REQUIREMENTS:
* 6+ years of regulatory submission experience in the pharmaceutical industry.
* Background in CMC and labeling.
* Previous work in pre-approval or post-approval submissions for the US marketplace and expert. knowledge of FDA Guidance Documents.