LEAD – REGULATORY AFFAIRS (Pharma)

Human Capital HR Solutions is recruiting on behalf of a well-established pharmaceutical organization for the position of Lead – Regulatory Affairs based in Karachi. This is a full-time role requiring a Pharm-D qualification. The successful candidate will lead the Regulatory Affairs function, ensuring compliance with pharmaceutical regulations and managing all aspects of product registration and regulatory submissions with DRAP and other relevant authorities. This role demands close collaboration with multiple departments including QA, QC, Manufacturing, R&D, and Supply Chain to maintain regulatory compliance throughout the product lifecycle.

Key Responsibilities
- Lead and oversee the Regulatory Affairs department, ensuring adherence to applicable pharmaceutical regulations.
- Manage product registration, renewal, variations, and regulatory submissions with DRAP and other regulatory bodies.
- Prepare, review, and maintain comprehensive regulatory dossiers and supporting documentation.
- Coordinate with internal teams such as QA, QC, Manufacturing, R&D, and Supply Chain to ensure regulatory compliance.
- Review product documentation including labeling, packaging materials, artwork, and promotional content from a regulatory perspective.
- Monitor updates and changes in regulatory guidelines and evaluate their impact on existing and new products.
- Ensure timely submission of regulatory applications, renewals, responses, and other required documentation.
- Handle regulatory correspondence and respond to queries from regulatory authorities.
- Support new product registrations and manage product lifecycle activities.
- Maintain accurate regulatory records and databases.
- Identify potential regulatory risks and recommend corrective actions.
- Provide regulatory guidance to internal stakeholders on product development, registration, compliance, and post-registration matters.

Required Qualifications
- Pharm-D degree is mandatory.
- Proven experience in Regulatory Affairs within the pharmaceutical industry.
- Strong knowledge of DRAP regulations, product registration processes, regulatory submissions, and compliance requirements.
- Hands-on experience managing product registrations, renewals, variations, and regulatory documentation.
- Excellent analytical, communication, coordination, and problem-solving skills.
- Ability to manage multiple regulatory projects simultaneously and meet strict submission deadlines.
- Solid understanding of pharmaceutical regulatory requirements and product lifecycle management.

Preferred Qualifications and Benefits
- Experience working with a reputable pharmaceutical organization is preferred.
- The ideal candidate is a Pharm-D professional with strong hands-on experience in Regulatory Affairs who can independently manage regulatory submissions, coordinate effectively with internal teams, and ensure timely compliance with regulatory standards.

This position requires working on-site in Karachi and offers an opportunity to contribute significantly to regulatory compliance and product lifecycle management within a leading pharmaceutical company.