Regulatory Specialist

6 days ago


Dublin, Dublin City, Ireland Team Horizon Full time

Team Horizon is seeking a Regulatory Affairs Specialist for an award-winning Healthcare & Pharmaceutical company based in the Midlands.

Why you should apply:

  • Join a dynamic, exciting company with huge growth prospects and a passion for innovation, their people and their products.
  • Flexible & Hybrid working opportunities.

What you will be doing:

  • Projects will be assigned to the role in line with business objectives.
  • Preparation and delivery of high-quality regulatory submissions and submission management plans for global regulatory agencies.
  • Independently prepare regulatory submissions and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and work to support the product portfolio.
  • Managing regulatory issues, maintaining submission information in relevant systems, tracking regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
  • Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.
  • Authoring and/or coordinating submission activities for new registrations, post-approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinating and contributing to responses to agency queries and performing quality review of regulatory submissions.
  • Maintenance of existing global regulatory approvals.
  • Prioritizing and independently completing assigned workload appropriately.
  • Managing and contributing to regulatory affairs-related projects, initiatives and actions.

What you need to apply:

  • Bachelor's degree or equivalent/graduate degree preferred in a science (Biology, Chemistry, Pharmacy or related science) and/or technical discipline.
  • Minimum of 5 years of hands-on Regulatory/CMC authoring experience preferable (initial registrations or post-approval variations).
  • Experience managing projects is preferable.
  • Action and results-orientated to achievement of goals and objectives.
  • Experience with leading and participating in several projects concurrently.
  • Ability to accurately scope projects and consider the full impact of decisions and actions taken.
  • Excellent interpersonal skills and ability to participate with cross functional teams in projects and innovation.
  • Strong presentation skills, able to engage people in technologies, products & services.
  • Functional expert in regulatory affairs with a passion for excellence.
  • Attention to detail and accuracy – essential.
  • Maintains direction & focus through proactive planning & organized approaches to work.
  • Resilient to objections, pressure and change in a fast-moving industry.
Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Other

Industries

Pharmaceutical Manufacturing and Health and Human Services

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