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 Intelligence to be based in their Dublin office.
This role is responsible for providing decision makers with the knowledge needed to act and make decisions faster. The individual fulfilling this role will interact with staff at various levels to connect their needs with the evolving regulatory climate to enhance the business strategy. This role will also assist in forecasting, developing, and managing resource demand, requirements and capacity planning for the regulatory intelligence function. This position will support activities and requests from all organizations within GxP framework with a primary focus on the European region.
Job Spec
Lead and mange junior regulatory staff in the following areas
Monitor new, revised or emerging regulatory requirements from a global to a local level
Notify teams and decision makers with regulatory information to enable them to refine strategies and better
manage potential risks
Write succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations and potential impact to business policies, process and strategies
Review, comprehend and track relevant regulatory information as it relates to the business and stakeholder requests
Accurately organize regulatory intelligence information in terms of area and subject
Identify and track key regulatory dates and deadlines for feedback on proposed regulations, rules and guidances
Identify emerging regulatory trends
Support requests from cross functional departments in providing regulatory intelligence
Develop a data gathering and escalation method to capture and communicate regulatory information and trends that impact clinical development
Support strategies and information requests for filings and submissions
May liaise with Legal to ensure consistency in interpretation of regulatory information
May serve as the Reg Intel lead on the organization’s cross-functional teams with new initiatives focus on changes to internal processes, policies and standards based on emerging regulatory intelligence information
May develop recommendations to draft rules and guidance documents by Health Authorities with regard to how they should be written or revised in collaboration with internal stakeholder
Resource Planning & People Management
Support Reg Intel’s resource planning and forecast needs
Manage forecasts as new projects emerge on an ad hoc basis, as well as quarterly re-forecasting for ongoing projects
Monitor the industry for quality and reliable regulatory intelligence resources
May manage multi regional team
Person Spec
- Ability to review and understand regulatory information
- Understanding of compliance issues, regulatory drivers, and terminology
- Excellent attention to detail and project management skills
- Experience in people management
- Highly organized
- Ability to work independently but provide value added outcomes
- Ability to foster constructive relationships regardless of role or level
- Effectively copes with ambiguity and adaptable to changes in directives
- High integrity and proactive
- A minimum Bachelor’s degree is required
- A focused degree in science or equivalent is a plus
- A minimum of 8+ years of experience in the clinical research industry
- Knowledgeable about regulations, regulatory pathways and approaches
- Knowledgeable about drug development lifecycle
- Experience navigating through information from Heath Authorities such as FDA, EMA, and Health Canada
CV to gerry@rftgroup.ie