Regulatory

  • location: Lexington, MA
  • type: Contract
  • salary: $117.46 - $138.19 per hour
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job description

Regulatory

Associate Director, Global Regulatory Affairs (CMC) IV

Job Summary

Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing a Core Dossier for Module 3 and preparing Module 3 documents to support Marketing Authorization Applications in Japan and Brazil. Provide support to other HA interactions as required.

Job Responsibilities

  • Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into submissions for marketing authorizations.
  • Provide Reg CMC support for development programs to ensure that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.
  • Manage preparation of Core Dossier, Japan and Brazil applications in a timely manner to meet corporate objectives.
  • Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives.
  • 30%: Develop global CMC Core Dossier for Module 3
  • 20%: Prepare Module 3 Marketing Authorization Application for Japan
  • 30%: Prepare Module 3 Marketing Authorization Application for Brazil.
  • 10%: Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines.
  • 10%: Provide CMC regulatory guidance to project / product teams.
Education & Qualifications

  • B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field. Minimum of 4 years experience in pharmaceutical product development including significant experience in CMC regulatory affairs with a strong biologics background or equivalent.
  • Experience in directing interactions with regulatory authorities desired.
  • Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance.
  • Significant coordination with cross-functional teams internally and regulatory authorities externally.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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