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NONovartis Pharmaceutical Manufacturing GmbH

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

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

Global CMC regulatory strategy development and submission coordination. Strong CMC regulatory understanding and scientific data evaluation skills required. Childcare facilities, learning and development options.

Requirements

  • English fluency (written and spoken)
  • Scientific degree or equivalent experience
  • CMC Regulatory Affairs capability
  • Strong CMC regulatory understanding
  • Scientific data evaluation skills
  • Pharmaceutical development knowledge
  • Cross-functional team collaboration
  • Planning and organisational skills

Tasks

  • Develop and implement global CMC regulatory strategies
  • Support regulatory activities across development and lifecycle stages
  • Plan and coordinate CMC submission activities
  • Author and review CMC regulatory documentation
  • Manage alignment on content, quality, and timelines
  • Communicate regulatory risks and updates to project teams
  • Prepare and support Health Authority interactions
  • Collaborate across functions for consistent delivery
  • Contribute to continuous improvement initiatives
  • Support knowledge sharing within the regulatory community

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degree

Languages

  • English – Native

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

  • Support for applicants with disabilities

Diverse Work

  • Advice on suitable positions

Mentorship & Coaching

  • Guidance at all stages of application process
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing GmbH 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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