Regulatory Affairs Executive

Regulatory Affairs Executive focuses on engagement with the mhra to address application queries, liaising with relevant company departments and external sources to ensure full and rapid responses.

What the role involves

• Engagement with the MHRA to address application queries, liaising with relevant company departments and external sources to ensure full and rapid responses.
• Creation, assessment and approval of artwork texts and mock-ups.
• Liaising with launch team to input the progress of regulatory application and/ or projects to assist with mapping out product launch activities.
• Handling the regulatory activities in relation to the re-introduction of license and coordination with other stakeholder to ensure execution of regulatory strategy in this regard.
• Handling labelling changes and associated regulatory applications (e.g. PIQ) as per business or external needs.
• Ensuring timely response to Corrective and Preventative Actions (CAPAs) assigned to DRA and other associated quality management activities.

Skills and requirements

• Experience (2 to 3 years) in Regulatory Affairs within a Generic or Pharma business.
• Experience in supporting new product launch activities.
• Experience in working with new product registration & CMC elements of a dossier.
• Experience in working with various variation applications.