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BA
Bayer
yesterday

Regulatory Affairs - Business Excellence Portal Manager(m/w/x)

Wuppertal, Berlin
Full-timeWith Home OfficeExperienced

Description

You will drive global clinical trial compliance by managing regulatory portals and interfacing with health authorities to ensure high-quality submissions and optimized digital workflows.

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Requirements

  • •Degree in biomedical life sciences or comparable field
  • •Years of experience in healthcare or pharmaceutical industry
  • •Skill in regulatory submission systems and EU-CTR
  • •Experience in complex data analysis and regulatory assessment
  • •Knowledge of global regulatory processes and digital platforms
  • •Problem-solving, structured communication, and cross-functional collaboration
  • •Fluent English (written and spoken)

Education

Bachelor's degree

Work Experience

approx. 1 - 4 years

Tasks

  • •Manage the CTIS Portal for centralized Clinical Trial Applications
  • •Coordinate and submit EU CTAs and lifecycle activities
  • •Collaborate with clinical, regulatory, and external stakeholders
  • •Oversee daily CTIS operations and interface with EU Health Authorities
  • •Analyze and manage regulatory and clinical data quality
  • •Identify emerging issues and develop mitigation strategies
  • •Inform stakeholders about impacts on project milestones
  • •Resolve technical challenges with Health Authorities and EMA Support
  • •Optimize submission portal systems and automation workflows
  • •Serve as a subject matter expert for audits and inspections

Tools & Technologies

Regulatory submission systemsEU-CTRDigital submission platforms

Languages

English – Business Fluent

Benefits

Competitive Pay

  • •Attractive base pay

Bonuses & Incentives

  • •Annual bonus
  • •Individual performance award
  • •Top performance award

Flexible Working

  • •Hybrid work models
  • •Part-time arrangements

Childcare

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

Other Benefits

  • •Elderly care time off

Learning & Development

  • •Learning and development opportunities
  • •Bayer Learning Academy training

Mentorship & Coaching

  • •Development dialogues
  • •Coaching and mentoring programs

Healthcare & Fitness

  • •Free health checks

Informal Culture

  • •Inclusive work environment
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