
Regulatory Affairs Specialist
19 hours ago
We are seeking a detail-oriented and forward-thinking Regulatory Affairs expert to lead and elevate the regulatory function. This role is crucial for enabling compliant growth in both local and international markets by ensuring timely product registrations, smooth regulatory inspections, and effective lifecycle management of all dossiers.
Key Responsibilities:
- Lead end-to-end regulatory strategy and operations across all product categories and markets.
- Oversee registration, renewal, and variation submissions for relevant authorities.
- Ensure all dossiers (local and international) are compliant, audit-ready, and continuously updated.
- Partner closely with R&D, manufacturing, and quality teams to ensure regulatory readiness and alignment.
- Coordinate with international teams or partners on regulatory submissions for export markets.
- Manage regulatory audits, inspections, and correspondence with authorities, ensuring transparent and timely engagement.
- Build and strengthen internal regulatory systems, SOPs, and document management tools.
- Stay ahead of evolving local and international regulatory frameworks and lead internal adaptations.
- Support 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 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.
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