Aijas Mohammad

Background

About Aijas Mohammad

As a dedicated and highly skilled Regulatory Affairs professional with extensive of regulatory experience in the pharmaceutical industry, I specialize in managing the full regulatory lifecycle of pharmaceutical products, from development through to post-approval. I have a proven track record in the preparation and submission of regulatory dossiers in compliance with EU and global standards, particularly within the veterinary and human pharmaceutical sectors. I have hands-on expertise in eCTD submissions, MRP, DCP, and national procedures, and I am proficient in regulatory strategy development and execution. Throughout my career, I have worked collaboratively with cross-functional teams to ensure timely market access and compliance with regulatory requirements, while also managing critical relationships with regulatory authorities and industry stakeholders. My experience spans regulatory dossiers for new product applications, generic submissions, renewals, variations, and license transfers. I am adept at reviewing and approving technical documentation, responding to regulatory queries, and ensuring that all activities are aligned with both internal and external expectations for compliance. In addition to my regulatory knowledge, I possess strong project management and communication skills, with the ability to thrive in fast-paced, dynamic environments while maintaining a sharp focus on quality, detail, and efficiency. Key Highlights: Regulatory Affairs Expertise: EU | FDA | Global Regulatory Compliance Submission Expertise: eCTD | MAA | NDA | BLA | MRP | DCP | National Filings Cross-functional Collaboration: Working seamlessly with R&D, Marketing, QA, and Legal teams Strong Compliance Focus: GMP | SOP | GDP | Internal audits Regulatory Strategy: Aligning product lifecycles with market and business needs Market Approvals & Variations: Managing the lifecycle from initial application to post-market changes I am always eager to bring my expertise and passion for regulatory affairs to new and exciting challenges. Let’s connect!