Hybrid Senior Specialist, Regulatory Affairs – CMC

Posted last month

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About the role

  • Senior Specialist in Regulatory Affairs focusing on site transfers for veterinary medicinal products. Maintaining CMC dossiers and ensuring regulatory compliance with cross-functional teams.

Responsibilities

  • Maintain and update regulatory CMC dossiers
  • (Co-)develop regulatory strategies and prepare documentation for change notifications, ensuring compliance with current regulatory quality standards
  • Respond promptly to inquiries from countries and regulatory authorities
  • Provide technical regulatory support to other functions
  • Collect and maintain regulatory information, accounting for the associated processes, and manage the relevant systems and databases

Requirements

  • Master's degree in Pharmacy, Chemistry, Food Chemistry or Biology
  • Ideally, professional experience in comparable positions within the pharmaceutical industry
  • Reliable, flexible, team-oriented and proficient in MS Office
  • Careful and responsible working style
  • Strong organizational skills combined with excellent communication skills in an international environment
  • Very good verbal and written language skills (English essential, German desirable)

Benefits

  • Flexible working hours (37.5 hours/week)
  • Attractive company pension scheme
  • Competitive compensation package: 13 monthly salaries + holiday pay + target bonus
  • 30 days' annual leave (depending on location)
  • Hybrid or remote working model (depending on location)
  • Internal training and development opportunities
  • International cooperation
  • On-the-job training
  • Opportunity to contribute ideas to process design
  • Insight into the development of veterinary medicinal products
  • Corporate benefits and free (electric) car parking
  • Good company canteen and a company health management program

Job title

Senior Specialist, Regulatory Affairs – CMC

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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