Regulatory Affairs Lead EMEA

작업 내용

For the expansion of our Regulatory Affairs team, argenx is looking for Regulatory Affairs Lead EMEA to support the team with regulatory activities.The role will report to the Head of Regulatory Affairs – EMEA.

Key Accountabilities/Responsibilities

The position will have the following key responsibilities:

• Leading regulatory submissions for the European Union. For this you will identify the documents needed for the submission, you will participate in their review to ensure they are complete and accurate, and you will participate in the QC check of the published output of the dossier. You will provide responses to regulatory agencies with support of the project team. You will also ensure that all submissions are aligned with the applicable global strategy of the company.
• Prepare and conduct Agency meetings, and prepare and distribute regulatory agency contact reports and meeting minutes.
• Ensure you keep up to date with regulations and guidelines and share information with the regulatory team.
• You may be involved in regulatory activities in other geographic regions.
  

Desired Skills And Experience

• 5-10 years of relevant experience in Regulatory Affairs within the pharmaceutical or biopharmaceutical industry.
• University degree, Master in Life Sciences.
• Having been involved with at least one end to end centralised procedure.
• Track record of successful interactions among international regulatory and health authorities
• Excellent organizational and project management skills, demonstrated strengths in strategic planning and workload prioritization
• Sound judgement and ability to analyze situations and information. Takes decisions based on facts and figures rather than on assumptions.
• Excellent interpersonal skills – able to work well and build relationships across a diverse set of stakeholders and characters.
• A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills
• You excel in a fast-paced, results-driven, highly accountable environment
• You resonate with the values of argenx and you are ready to drive the Company Culture
• Able to travel based on business needs.
• Medical writing skills is an asset.
• Fluent in English (oral and written).