Job Description
Our client is a young exciting multinational biopharmaceutical company known for its scientific and operational excellence enjoying exceptional growth combined with a strong high potential pipeline. Rapid expansion has led to the need to create a management position in Regulatory Affairs clinical development to be based in their Dublin office. The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in our Dublin office.
Job Spec
The Regulatory Affairs Specialist/Associate Manager supports clinical trial application and related regulatory activities in EU and ex-US markets. This role is intended to support more senior regulatory experts in the EU and will be based in the Dublin office. Additional activity includes supporting agency interactions, assisting in the management of agency correspondence and submissions and tracking emerging legislation with business impact.
Provide hands on support for the submission and tracking of clinical trial applications including national, VHP and applications submitted under the emerging clinical trial Regulations.
Manage and maintain approved CTAs and ensure compliance with applicable ICH GCP principles and national/regional equivalents.
Work with clinical study teams to ensure appropriate regulatory support from CROs and other partners.
Serve as additional resource to regulatory teams to track changes in legislation and guidelines thereby ensuring the company remains compliant with same.
Ensure agency correspondence is filed and archived in accordance with company’s processes.
Support agency interactions such as scientific advice, national meetings etc.
Work with the team to build the profile of the EU group with both internal and external stakeholders.
Person Spec
Knowledge of clinical trial and associated regulatory processes
Strong Technical writing and oral communication skills essential
Entry level understanding of pharmaceutical regulatory affairs
Education
• Degree in life sciences. Masters or PhD preferable.
Experience
• 3+ years’ experience working within the pharmaceutical industry or related environment
CV to gerry@rftgroup.ie