Girish H.

An accomplished Regulatory, Quality, and Clinical Affairs professional with over 16 years of experience in developing and executing regulatory strategies to ensure compliance with global regulatory requirements. Demonstrated expertise in leading cross-functional and multidisciplinary teams, building and sustaining strong relationships with key stakeholders, and translating complex regulatory and clinical information into clear, concise, and actionable communications. Possesses broad, hands-on experience across regulatory affairs, quality assurance, clinical trials, labelling, and real-world evidence, complemented by strong project management capabilities. Proven ability to work both independently and collaboratively within multicultural and cross-functional organisations. A subject-matter expert in medical and regulatory writing, with extensive experience in preparing and reviewing CEPs, CERs, PMS Plans and Reports (PMSP/PMSR), PMCF Plans and Reports, PSURs, BEPs, BERs, and SSCPs in compliance with EU MDR requirements. Highly experienced in drafting clinical study protocols, protocol amendments, and clinical study reports. Brings a deep understanding of international regulatory frameworks, requirements, and systems that enable successful product development, market access, and the generation of new research opportunities and revenue streams.