Regulatory Strategy Manager

2 days ago

Karachi, Sindh, Pakistan beBee Careers Full time
Regulatory Strategy Manager

This role is critical to the success of a leading business group, requiring a seasoned professional with expertise in regulatory affairs and a strong ability to influence cross-functionally.

The Regulatory Strategy Manager will be responsible for developing and implementing an end-to-end regulatory strategy and operations plan across all product categories and markets, ensuring timely product registrations, smooth regulatory inspections, and effective lifecycle management of all dossiers.

Key Responsibilities:

  1. Develop and implement a comprehensive regulatory strategy and operations plan, aligning with the organization's goals and objectives.
  2. Oversee registration, renewal, and variation submissions for DRAP and relevant global authorities, ensuring compliance with regulations and guidelines.
  3. Maintain up-to-date knowledge of evolving local and international regulatory frameworks and adapt internal policies accordingly, staying ahead of changes and trends.
  4. Collaborate with R&D, manufacturing, and quality teams to ensure regulatory readiness and alignment, promoting a culture of compliance throughout the organization.
  5. Manage regulatory audits, inspections, and correspondence with authorities, ensuring transparent and timely engagement.
  6. Implement and maintain robust internal regulatory systems, SOPs, and document management tools, ensuring seamless integration with existing processes.
  7. Provide strategic guidance on regulatory matters, supporting product development, new launches, and business expansions while minimizing risks.

Requirements:

  • 10+ years of experience in regulatory affairs within the pharmaceutical industry.
  • In-depth understanding of DRAP processes and documentation requirements, as well as familiarity with global regulatory frameworks (e.g., WHO PQ, GCC, ASEAN, etc.).
  • Proven track record of managing product lifecycles across domestic and export markets, demonstrating expertise in regulatory compliance and risk management.
  • Strong leadership and interpersonal skills, with the ability to influence cross-functionally and foster a culture of compliance.
  • Excellent communication and stakeholder management skills, with a focus on building and maintaining relationships with key stakeholders.

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