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Biotech Partners | Biotech Executive Search

Biotech Partners | Biotech Executive Search

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Regulatory Affairs Senior Manager

June 2, 2020 by

  • Date Posted June 2, 2020
  • Location Chicago, Illinois
  • Job Type Direct Hire
  • Job ID 2124

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.

Specific Responsibilities:

  • 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

Qualifications:

  • 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

Qualified Candidates Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

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Biotech Partners finds the talent that finds the cure. From helping you find the perfect life sciences candidate or matching applicants up with their dream role, you’ll find Biotech Partners committed to your success. That’s why we have a 5-year quality guarantee.

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