Senior Regulatory Affairs Associate
Columbus, Ohio
Our client is looking to hire for a Senior Regulatory Affairs Associate who can draw upon their experience 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 catalogue. They have continuously acquired companies throughout the world, and this role specifically will be at their most recently acquired facility which is allowing them to build up their non-injectables business in the US.
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.
