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 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
registratio

📌 Regulatory Affairs Head (Chandigarh)
🏢 TalentXplore
📍 Chandigarh