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BA
Bayer
7d ago

CMC-D Manager(m/w/x)

Darmstadt
Part-timeWith Home OfficeExperienced

Description

As the Brand Lead for herbal products, you will drive CMC-D strategy and regulatory compliance. You'll balance technical authoring with leadership by coaching junior staff and optimizing functional processes.

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Requirements

  • Desirable phyto-specific regulatory experience for Module 3
  • Degree in scientific field or international equivalent
  • Strong understanding of product development processes
  • Knowledge of ICH and quality-system guidelines
  • Familiarity with USP, Ph. Eur., and Pharmacopoeias
  • Understanding of regulations and industry standards
  • Strong understanding of cGMP and Quality Assurance
  • Analytical, problem-solving, and project management skills
  • Effective communication and cross-functional collaboration
  • Detail-orientation, accurate documentation, and teamwork
  • Proficient English communication skills

Education

Bachelor's degree
OR
Master's degree
OR
Doctoral / PhD

Tasks

  • Act as the Brand Lead for herbal Consumer Health Products
  • Manage CMC-D strategies for NPD and LCM projects
  • Apply specific herbal regulatory requirements to brand strategies
  • Author scientific briefing documents and complex TRDs
  • Draft responses to health authority questions
  • Approve TRDs for new product developments
  • Conduct CMC-D assessments for business due diligence
  • Manage CMC-D change impact assessments
  • Lead category continuous improvement initiatives
  • Provide coaching and training to junior colleagues
  • Manage relevant functional processes

Tools & Technologies

ICHUSPPh. Eur.PharmacopoeiascGMP

Languages

EnglishBusiness Fluent

Benefits

Competitive Pay

  • Attractive base pay

Bonuses & Incentives

  • Annual bonus
  • Individual performance award

Other Benefits

  • Flexible and appreciative benefits
  • Elderly care time off

Flexible Working

  • Hybrid work models
  • Part-time arrangements

Childcare

  • Company daycare centers
  • Childcare search support
  • Summer camps for children

Learning & Development

  • Learning and development opportunities
  • Bayer Learning Academy training

Mentorship & Coaching

  • Development dialogues
  • Coaching and mentoring programs

Healthcare & Fitness

  • Health awareness measures
  • Free health checks

Informal Culture

  • Inclusive work environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bayer 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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