Regulatory Affairs Head
Regulatory Affairs Head
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Key Responsibilities:
- Regulatory Strategy and Compliance:
- Develop and implement regulatory strategies for product registrations in the UK and other MHRAregulated markets.
- Ensure compliance with MHRA regulations guidelines and standards.
- Oversee the preparation and submission of regulatory dossiers for new product registrations renewals and variations.
- Submission and Approvals:
- Manage endtoend 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).
- 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.
- 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).
- Lifecycle Management:
- Manage postapproval activities including labeling updates safety monitoring and periodic reporting.
- Handle pharmacovigilance requirements in collaboration with relevant teams.
- Ensure product compliance throughout its lifecycle in MHRAregulated markets.
- 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.
- Global Regulatory Compliance:
- Monitor international regulatory landscapes and adapt strategies to align with global compliance.
- Supportregistrations and approvals in other regulated markets (e.g. EU US FDA) asneeded.
Employment Type
Full-Time
