Our client is seeking a Regulatory Affairs Senior Manager in Chicago, Illinois!
Our client is a pharmaceutical company that specializes in developing, manufacturing and marketing branded/generic drugs as well as animal/consumer health products. Additionally, they specialize in manufacturing sterile/non-sterile dosage forms. This is a well-established company in the life sciences with a lot of potential for upward mobility. This Regulatory Affairs Senior Manager position will be responsible for ensuring the completion of regulatory filings and the submission process to the appropriate authorities (FDA). This role will oversee the company’s regulatory strategy and make appropriate changes to the SOP’s when needed.
- Responsible for managing the regulatory associates/specialists and the processes in preparing and submitting documents (originals, supplements, amendments, annual reports) to the Food and Drug Administration
- Develop the company’s regulatory strategy and implement these plans ensuring they are following FDA guidelines
- Analyze study reports/data required during the submission process, making sure they align with FDA/ICH/CMC guidelines
- Establish timelines/regulatory benchmarks for the company’s product development teams and key agency filing instances
- Act as the lead for the creation of product labeling fulfilling regulatory requirements
- Communicate with the R&D/Quality to collect appropriate data for the regulatory submissions
- Bachelor’s degree in chemistry or related field in the sciences (advanced degree preferred)
- Ten or more years of pharma industry experience (Five plus years of direct regulatory affairs experience)
- Motivated self-starter that understands the big picture and has a proven track record of growth/achievement with prior companies
- A strong scientific background with extensive pharmaceutical regulatory affairs experience
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