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NONovartis

Manager, Regulatory Affairs CMC(m/w/x)

Schaftenau
from 65,605.54 / year
Full-timeWith Home OfficeExperienced

Managing global regulatory submissions for pharmaceutical product chemistry, manufacturing, and controls. Science degree and two years' regulatory or pharmaceutical experience essential. On-site childcare facilities.

Requirements

  • Science degree or equivalent qualification
  • Two years' regulatory CMC or pharmaceutical experience
  • Knowledge of chemistry, analytics, or pharmaceutical technology
  • Knowledge of regulations and product life cycle
  • Ability to critically evaluate scientific data

Tasks

  • Lead global CMC regulatory strategies
  • Balance business benefits with compliance
  • Manage global CMC submission activities
  • Coordinate technical source document delivery
  • Author high-quality CMC submission documentation
  • Ensure technical congruency and compliance
  • Meet e-publishing and timeline requirements
  • Communicate regulatory risks to stakeholders
  • Represent the department in cross-functional teams
  • Prepare CMC risk management assessments
  • Lead Health Authority interactions and negotiations

Work Experience

  • 2 years

Education

  • Vocational certificationOR
  • Bachelor's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • Chemistry
  • Pharmacy
  • Biochemistry
  • Molecular Biology
  • Biotechnology
  • Biology
  • Regulatory CMC
  • Pharmaceutical technology

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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