
Chief Regulatory Officer
23 hours ago
This key position will lead regulatory strategy and operations, ensuring compliant growth in local and international markets.
The ideal candidate will possess a blend of deep regulatory expertise and strong cross-functional influence, especially across manufacturing, quality, supply chain, and business leadership.
Key Responsibilities:
- Develop and implement end-to-end regulatory strategies for all product categories and markets.
- Oversee registration, renewal, and variation submissions for DRAP and relevant global authorities.
- Maintain compliant dossiers (local and international) and ensure audit-readiness at all times.
- Collaborate closely with R&D, manufacturing, and quality teams to ensure regulatory readiness and alignment.
- Coordinate with international teams on regulatory submissions for export markets.
- Manage regulatory audits, inspections, and correspondence with authorities, ensuring transparent engagement.
- Develop and strengthen internal regulatory systems, SOPs, and document management tools.
- Stay ahead of evolving local and international regulatory frameworks and lead internal adaptations.
- Provide regulatory inputs into product development, new launches, and business expansions.
Requirements:
- 10+ years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth understanding of DRAP processes and documentation requirements.
- Experience managing product lifecycles across both domestic and export markets.
- Proven ability to lead teams and influence cross-functionally across technical and commercial domains.
- Strong documentation, compliance, and stakeholder management skills.
- Familiarity with global regulatory frameworks is a plus.
Our organization values innovation and excellence. We are looking for individuals who can bring their expertise to shape our future success.
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