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Regulatory Affairs Manager, Westmeath



Westmeath, Ireland 

Job Category:

Biotech/Pharma, Science

EU work permit required:


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Job Description:

We are seeking applications for an experienced Regulatory Affairs Manager for our client, who is a leading biopharmaceutical company based in Athlone.
Why you should apply:
  • This is an exciting opportunity to join a fast growing international company whose culture centres on making lives better.  You would be working within a vibrant, entrepreneurial environment alongside passionate team members who share a vision to discover, develop & commercialise pioneering technologies and solutions
What you will be doing:
  • Preparation and delivery of high-quality CMC regulatory submissions and submission management plans for global regulatory agencies.
  • Independently prepare regulatory assessments and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and work to support the product portfolio.
  • Serving as CMC representative on a core project(s), managing project activities, assessing regulatory risks & development plans to develop global regulatory strategies.
  • 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.
  • Developing effective relationships with local and global internal partners
  • Managing and contributing to regulatory affairs-related projects, initiatives and actions.
  • Mentoring colleagues within focused area of expertise
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 3+ years of hands-on Regulatory/CMC authoring experience preferable (initial registrations or post-approval variations)
  • Advanced skills in written and oral communications are required
  • Computer literacy with Microsoft Office applications
  • 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
  • Manage personnel directly or indirectly to achieve the objectives of the applicable strategic project
  • Maintains direction & focus through proactive planning & organized approaches to work
  • Resilient to objections, pressure and change in a fast-moving industry
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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