Regulatory Affairs Strategic Partner

1 day ago

Vejle, Vejle Kommune, Denmark Vectura Fertin Pharma Full time

Company Overview:

Vectura Fertin Pharma is a global leader in the development and commercialization of respiratory products. We have ambitious plans to grow our business in established markets within select consumer health categories.

Job Description:

We are seeking a Senior Regulatory Affairs Specialist to join our team in Vejle, Denmark. As a key member of our Regulatory Affairs department, you will play a critical role in supporting commercial projects and market expansions.

Main Responsibilities:

  1. Project Scoping and Planning: Collaborate with cross-functional teams to scope and plan projects, ensuring alignment with regulatory requirements.
  2. Regulatory Submission Processes: Develop and implement regulatory strategies for submission to authorities or alignment with customers.
  3. Collaboration and Communication: Serve as a regulatory sparring partner for colleagues from product and analytical development, quality, and other functions.
  4. Regulatory Strategy Development: Develop and maintain up-to-date knowledge of regulatory requirements and guidelines, providing strategic input on regulatory approaches.
  5. Project Management: Support project management for risk management of activities with regulatory impact.
  6. Regulatory Deliverables: Ensure timely delivery of regulatory documents and submissions, adhering to project timelines and quality standards.

Required Skills and Qualifications:

  • Education: M.Sc. in pharmacy, biology, chemistry, or a related field.
  • Experience: Minimum 5 years' experience in regulatory affairs or a related field, with a strong understanding of regulatory requirements and guidelines.
  • Language Skills: Fluency in English, both written and spoken, with excellent communication skills for an international working environment.
  • Personal Capabilities: Proactive, systematic approach to establishing and discussing regulatory strategies, with a supportive attitude and ability to manage a fast-paced environment.

Benefits:

  1. Opportunity for Growth: Be part of our ambitious growth strategy, influencing work processes and developing competencies.
  2. Work-Life Balance: Enjoy a place in our dedicated team with the option to work from our office in Vejle or remotely.

How to Apply: Send your cover letter and CV via the link below. Interviews will be conducted on an ongoing basis.

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