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Manager Regulatory Affairs CMC

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Laura Schollen
Recruiter



Laura Schollen
Recruiter


Jobomschrijving

The successful candidate will;

  • support all regulatory CMC aspects of an assigned product portfolio associated with business objectives, veterinary drug development projects, regulatory change management and/or routine registration maintenance. 
  • Develop regulatory CMC filing strategies for global pharmaceutical dosage forms. 
  • Support CMC activities for new product development teams and post-approval manufacturing changes or site transfers. 
  • Prepare responses to global Health Authority queries including FDA/CVM. 
  • Maintain knowledge and awareness of emerging global biopharma and pharmaceutical CMC regulations and assist in the development of regulatory positions and strategies. 
  • Develop strong working relationships with both manufacturing sites and contract manufacturing interfaces for assigned portfolio.
  • Provide regulatory support and serve as a technical liaison on Development teams in their efforts to deliver a quality CMC technical section that will meet global requirements for registration, approval and launch of a new product.   
  • Develop a knowledge of CMC regulatory science.  Work with VMRD Partner groups to ensure appropriate alignment and sharing of best practices.


Profiel

  • Minimum of a Bachelor degree/ Master degree
  • 6 years of analytical, manufacturing, and regulatory experience with biologics, biopharmaceutical or pharmaceutical products. 
  • Experience in a regulatory liaison role working directly with FDA (CVM) or other global Health Authorities in the area of biological, biopharmaceutical or pharmaceutical registration and compliance is highly desirable.
  • Strong technical background and excellent communications skills required with regulatory experience highly preferred. 
  • Must have the ability to work within teams, including collaborating with colleagues, maintaining partnerships with other departments, serving on cross-functional teams, as well as cross divisional teams (Co-development). 
  • Must have the ability to establish and maintain appropriate timelines   
  • Demonstration of an ability to handle several projects simultaneously under minimal supervision 
  • Good negotiating skills.
  • Experience in using problem-solving skills
  • Must be able to apply high level informatics and document management skills within a matrix, cross divisional environment. 
  • Must demonstrate integrity in all areas of the work environment
  • Understanding of GMPs for sterile and non-sterile manufacturing
  • Understanding of global standards for analytical testing
  • Very self-directed - can work with little supervision on most tasks
  • Excellent organization, prioritization, and time management skills – can work effectively under pressure
  • Excellent written and oral communication skills
  • Experience with an animal health portfolio
  • Manage and adapt to change.
  • Position may require some travel less than 10%

Aanbod

Permanent contract

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