Regulatory Affairs Head

Key Responsibilities:​​

1. Regulatory Strategy and Compliance:​
   
• Develop and implement regulatory strategies for product registrations in the UK and other MHRA-regulated markets.
  
• Ensure compliance with MHRA regulations, guidelines, and standards.
  
• Oversee the preparation and submission of regulatory dossiers for new product registrations, renewals, and variations.
  
2. Submission and Approvals:
   
• Manage end-to-end regulatory submission processes, including Module 1 to Module 5 preparation as per CTD (Common Technical Document) format.
  
• Liaise with MHRA for product approvals, inspections, and resolution of queries.
  
• Handle Marketing Authorization Applications (MAAs).
  
3. Team Leadership and Coordination:
   
• Lead and mentor the regulatory affairs team to ensure timely and accurate submissions.
  
• Coordinate with R&D, QA, QC, and manufacturing teams for the collation of regulatory documents and data.
  
• Develop training programs for the regulatory team on current guidelines and best practices.
  
4. Audits and Inspections:
   
• Prepare the organization for MHRA audits and inspections.
  
• Ensure readiness for regulatory audits by maintaining proper documentation and processes.
  
• Address regulatory findings and implement corrective and preventive actions (CAPA).
  
5. Lifecycle Management:
   
• Manage post-approval activities, including labeling updates, safety monitoring, and periodic reporting.
  
• Handle pharmacovigilance requirements in collaboration with relevant teams.
  
• Ensure product compliance throughout its lifecycle in MHRA-regulated markets.
  
6. Stakeholder and Agency Liaison:
   
• Act as the primary point of contact with MHRA and other regulatory agencies.
  
• Provide regulatory intelligence and updates to senior management regarding changes in MHRA guidelines and regulations.
  
• Collaborate with external consultants and partners as needed.
  
7. Global Regulatory Compliance:
   
• Monitor international regulatory landscapes and adapt strategies to align with global compliance.
  
• Support registrations and approvals in other regulated markets (e.g., EU, US FDA) as needed.