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Regulatory CMC Specialist
Ref No.: 18-00481
Location: Collegeville, Pennsylvania
Position Type:Contract
Start Date: 04/11/2018
Project Description:
  • Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply these, particularly for new medicines in development.
  • Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
  • Excellent team working abilities and effective influencing skills.
  • Strong verbal and written communication skills with good attention to detail.
  • Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
  • Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
  • Hands-on experience in CMC regulatory writing/submission for drug product.
  • Experience in authoring NDA/MAA drug product modules for small molecule injectable dosage form is preferred.
  • Experience in authoring CMC submission documents from early phase clinical submissions through to marketing applications and early lifecycle activities.
  • Experience in authoring CMC submission documents for NDA/MAA is preferred.
  • Experience in authoring small molecule injectable dosage form is preferred.
  • Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications.
  • Work in cross-functional matrix project teams, which include colleagues from regulatory, chemical and pharmaceutical development and manufacturing.
  • Demonstrates networking skills through interactions across departments, divisions, and disciplines.
  • Familiar with cGMP and regulatory requirements for manufacturing operations and documentation.

Required Skills:
  • Bachelor degree in pharmacy, chemistry or related scientific discipline or equivalent qualification.
  • Chemistry, Manufacturing and Controls (CMC) regulatory affairs or chemical and pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
  • Good oral and written communication skills.

This 11+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: