Key Responsibilities:​​
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 current product registrations, renewals, and variations.
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).
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 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.
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.
Support registrations and approvals in other regulated markets (e.g., EU, US FDA) as needed.

📌 Regulatory Affairs Head Chandigarh
🏢 TalentXplore
📍 Chandigarh