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NONovartis

Associate Director, Regulatory Affairs CMC(m/w/x)

Schaftenau
from 78,383.9 / year
Full-timeOn-siteSenior
Apply now

Leading global CMC submission planning and authoring for diverse pharmaceutical projects. Minimum 8 years regulatory or pharmaceutical experience required. On-site childcare facilities.

Requirements

  • Science degree or equivalent
  • Minimum 8 years regulatory or pharmaceutical experience
  • Knowledge in regulatory submission and CMC issues
  • Ability to critically evaluate scientific data

Tasks

  • Drive global CMC regulatory strategies for diverse projects
  • Lead all global CMC submission planning and authoring
  • Coordinate and review technical submission documentation
  • Identify and resolve content or quality issues
  • Negotiate delivery of technical source documents
  • Author high-quality CMC documentation for Health Authorities
  • Ensure technical congruency and regulatory compliance
  • Meet e-publishing requirements and project timelines
  • Represent Global Regulatory CMC on cross-functional teams
  • Maintain collaborative partnerships with key stakeholders
  • Lead Health Authority interactions and negotiations
  • Prepare briefing books and risk mitigation plans
  • Act as the primary contact for the FDA
  • Provide strategic advice through specialized assignments

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degree

Languages

  • English – Business Fluent

Benefits

Competitive Pay

  • Market-competitive base salary

Bonuses & Incentives

  • Attractive incentive program

Retirement Plans

  • Modern company pension scheme

Childcare

  • Childcare facilities

Learning & Development

  • Learning and development options

Career Advancement

  • Worldwide career opportunities

Other Benefits

  • Recruitment process adjustments
  • Disability representative involvement
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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