Profile Details

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USD 150 /hr

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Hire Waqas A.

Pakistan

USD 150 /hr

Regulatory Affairs / Quality Operations Professional (Pharmaceuticals) | RA Freelancer & Consultant

Profile Summary

PROFESSIONAL PROFILE: A Regulatory Affairs/ Quality Operations Professional with thirteen years drug development experience (Pharmaceutical), which within global regulatory affairs. Broad experience across various therapeutic areas. Proven scientific, regulatory and managerial expertise in driving both early development teams and full development programs (overseeing the preparation of CTD, ACTD, NDA and specific dossier format, successfully submission, cGMP inspection / general inspection as per requirement of global health authorities / manufacturing requirements).A proven ability to lead and manage quality teams through complex global regulatory submissions and interactions with numerous global health authorities (including DRAP, TFDA, NDA, EFMHACA, ZMRA, MINISANTE, NMRA, PPB, LMHRA,CIS Countries, WHO and other regional country authorities).Ability to could be adjusted in highly professional demanding fields like Human Resources Management, Administration and Top Management Level – Strategic and Planning Division.

Subject Matter Expertise

• ★ Regulatory Writing
• ☆ Medical Device Regulatory Consulting
• ☆ Regulatory Affairs
• ☆ Product Compliance

Services

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing

Research Fact Checking, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Product Development Formulation

Work Experience

Manager Regulatory Affairs

ZAFA Pharmaceuticals

August 2018 - Present

Education

Double Masters

University of Karachi

June 2010 - June 2014

Certifications

• Certification details not provided.