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3167 MSDAnimalHealthInnovation
yesterday

Senior Specialist, Global Regulatory Affairs(m/w/x)

Schwabenheim an der Selz
Full-timeWith Home OfficeSenior

Description

You will drive global compliance by managing product registrations and life cycle activities. Your day-to-day involves coordinating complex submissions and aligning regulatory strategies with portfolio goals.

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Requirements

  • •University degree in Veterinary Medicine
  • •Multi-year regulatory experience in animal health
  • •Excellent communication skills
  • •Proficiency in English and MS Office
  • •Proficiency with Veeva Vault
  • •Result-oriented and well-structured working style
  • •Strong interpersonal skills and sound judgement
  • •Attentiveness to details
  • •Experience in Drug Regulatory Affairs
  • •Project Management skills
  • •Ability to work across borders

Education

Bachelor's degree

Work Experience

approx. 4 - 6 years

Tasks

  • •Represent Global Regulatory Affairs in portfolio optimization projects
  • •Implement new veterinary regulations and update packaging materials
  • •Organize documents and data for marketing authorizations
  • •Ensure materials align with the licensing strategy
  • •Prepare technical statements with internal and external experts
  • •Coordinate updates for product literature, leaflets, and labels
  • •Manage regulatory submissions and respond to authority inquiries
  • •Assess post-approval changes and provide filing strategies
  • •Maintain regulatory information to ensure ongoing compliance
  • •Develop technical knowledge of pharmaceutical product development
  • •Communicate potential regulatory issues to management

Tools & Technologies

MS officeVeeva Vault

Languages

English – Business Fluent

Benefits

Flexible Working

  • •Flexible working hours
  • •Hybrid working model

Additional Allowances

  • •13 monthly salaries

Bonuses & Incentives

  • •Target bonus

Retirement Plans

  • •Attractive company pension scheme

More Vacation Days

  • •30 days holiday entitlement

Learning & Development

  • •Internal training opportunities
  • •Training on the job

Career Advancement

  • •Promotion opportunities

Other Benefits

  • •International co-operations
  • •Medicinal product development insights
  • •Working across borders

Purpose-Driven Work

  • •Process design contribution

Parking & Commuter Benefits

  • •Free car parking

Generous Parental Leave

  • •Paid Parental Time Off
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