Mohammed Nizam

Mt self Nizamuddin I'm from Visakhapatnam

PROFESSIONAL SUMMARY

Clinical Research and Regulatory Affairs professional with over 2+ years of experience in clinical trial site management and pharmaceutical business development. Proven expertise in ICH-GCP compliance, regulatory submissions, patient recruitment, and coordination with sponsors, CROs, and investigators. Currently working in Regulatory

Affairs & International Business Development, with hands-on experience in global market entry strategies, dossier preparation (CTD/ACTD), and international regulatory compliance. Strong ability to manage audits, resolve queries, and ensure seamless clinical and regulatory operations while maintaining high-quality standards

WORK EXPERIENCE

INTERNATIONAL BUSINESS DEVELOPMENT EXECUTIVE

HUMANIQE BIOPHARMACEUTICALS PVT.LTD 2025 May to Till Now

• Identify and establish new international markets for pharma products.

•Build relationships with overseas distributors, hospitals, government agencies, and multinational buyers.

• Supported regulatory submissions and product registrations for international markets.

•Coordinated preparation and review of regulatory dossiers (CTD) and supporting documents.

 Ensured compliance with country-specific regulatory requirements, export guidelines,

and drug approvals.

 Acted as a bridge between regulatory affairs, quality assurance, and business development teams.

 Conducted regulatory intelligence and market entry feasibility for global markets.

CLINICAL RESEARCH EXPERIENCE

Medicover Hospital

Senior Clinical Research Coordinator – 2024 to 2025

• Overseeing day-to-day site operations for multiple clinical trials, ensuring compliance with ICH-GCP and regulatory guidelines.
• Leading site feasibility, qualification, initiation, and monitoring activities.
• Supervising and mentoring study staff, coordinating with investigators, sponsors, and

CROs.

• Ensuring accurate site documentation, IP accountability, and timely query resolution.
• Managing audits and monitoring visits, addressing findings promptly.

QED Research Services

Clinical Research Coordinator – Jan 2023 to 2024

• Coordinated with the Principal Investigator, institution, and CRA for PSSV.
• Prepared site feasibility and site qualification visit documentation.
• Reported study updates in a timely manner to the Institutional Ethics Committee.
• Responsible for training of study site team, recording and maintenance of essential documents, and site initiation.
• Worked with EDC systems such as Clinion & IWRS.
• Handled IP accountability and reconciliation.
• Supported monitoring visits, sponsor/CRO audits, and third-party audits.
• Assisted PI with Informed Consent Form (ICF) procedure.

ACADEMIC QUALIFICATIONS

• M. Pharmacy – Raghu College of Pharmacy, A.U., 2023
• B. Pharmacy – Raghu College of Pharmacy, A.U., 2020
• Intermediate – Sri Chaitanya Jr. College, B.I.E., 2016
• 10th Class – Pollocks School, S.S.C., 2014