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Associate Director, Regulatory Labeling

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Associate Director, Regulatory Labeling

Northeast

Our client is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Company markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.

This position will offer hands-on regulatory experience in an innovative company. Working on groundbreaking tasks, your work will hasten the drug manufacturing process. You will report to the Director of Regulatory Labeling.

Responsibilities:

  • Manage the development, review, approval, and maintenance of labeling for designated products
  • Participates in the product development team for the early development team and assist with guiding the design and analyzing the plan for clinical trials
  • Mentor junior staff members on labeling projects and process management to build labeling expertise
  • Maintain and manage labeling projects for CCDS, UPSI, EU SmPC, and local labeling
  • Monitor worldwide regulation changes of Labeling

Qualifications:

  • B.S., Masters, or PharmD. in related field or
  • 8 years of industry regulatory experience in place of college degree
  • 5+ years experience in regulatory labeling