Manager Regulatory Affairs

Description

The Manager Regulatory Affairs at Hamdard Pakistan plays a crucial role in overseeing the regulatory processes related to pharmaceutical products. This position requires a professional with substantial experience in regulatory compliance, product registration, and quality assurance to ensure that all products meet the stringent standards set by regulatory authorities. The manager leads a team of five, coordinating efforts to prepare, submit, and maintain product registrations and renewals while diligently monitoring regulatory updates and managing audits and inspections. This role demands active collaboration with regulatory bodies such as DRAP and other agencies to guarantee adherence to applicable laws and guidelines. This leadership position also involves reviewing labeling, packaging, and regulatory documents to maintain consistency with compliance requirements. The ideal candidate holds a Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or a closely related field, with at least eight years of experience in the pharmaceutical industry. Strong leadership and communication skills are essential for successfully managing the team and for facilitating effective cross-functional collaboration to maintain product compliance and uphold quality standards.

Responsibilities

• Manage and oversee product registrations, renewals, and all regulatory submissions to ensure timely compliance.
• Ensure strict adherence to applicable regulatory requirements and pharmaceutical industry standards throughout product life cycles.
• Coordinate with regulatory authorities such as DRAP and other relevant agencies to address regulatory queries and compliance issues.
• Review and approve product labeling, packaging, and regulatory documentation to guarantee conformity with regulations.
• Collaborate effectively with cross-functional teams including quality assurance, manufacturing, and marketing to maintain regulatory compliance.
• Monitor and interpret ongoing regulatory changes and updates to ensure the company’s practices remain current and compliant.
• Lead the preparation and management of regulatory inspections and audits, ensuring readiness and timely response to findings.
• Develop and implement regulatory strategies to support new product development and existing product maintenance.
• Provide leadership and mentorship to a team of five regulatory affairs professionals, fostering continuous development and performance excellence.
• Maintain comprehensive and organized regulatory records and documentation for audit readiness and regulatory reviews.
• Analyze regulatory requirements and provide guidance to internal stakeholders on compliance and regulatory pathways.
• Support the development and execution of quality assurance programs related to regulatory compliance.

Experience

8 Years

Apply By

Nov 9, 2026

Required Skills

• Regulatory Compliance
• Regulatory Strategy
• Quality Assurance
• Product registration
• Audit Management
• Regulatory Documentation

Nice to Have Skills

• Leadership
• Communication
• Cross-functional collaboration