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 recent 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