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.