Moiz A. Email & Phone Number

Corvallis, Oregon, United States

Worked in IND and ANDA

South Sanfrancisco

Maryland Heights MO

Worked on Ad-Promo, NDA and Labeling Projects.

Thousand Oaks California

• Responsible for Filling necessary applications, coordinate of state wholesale distribution licensing renewals, and handling all government interactions pertaining to the regulation process for products requiring.
• Developed procedures to ensure regulatory compliance, and supporting the extended Regulatory Affairs team with preparation of regulatory filling and amendments
• Working on EDMT/ EPIC database.

Create, review, and approve ANDA and Stability Protocols and nonconformance paperwork in controlled documentation system.Write work instructions, release SOPs, and create forms to establish quality documentation.Develop of matrices for ECOs and complaints and for management review.Work with cross-functional team to implement and maintain consistent.

Greater San Diego Area

• Compiling of BLA dossiers in eCTD format under (21 CFR 11.2(b) (2)),for Submission to FDA specifically for Plasma Drug product.
• Work with cross-functional team to implement and maintain consistency.
• Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format – Biologics Marketing Applications,and Providing Regulatory Submissions in Electronic Format
• Working on Post approval changes pursuant to 21CFR 601.2, 21CFR 601.12(c), 21 CFR 601.12(c)(5) and Annual Reports per Title 21 Code of Federal Regulations section 601.12(d).

Compiling of BLA dossiers in eCTD format under (21 CFR 11.2(b) (2)),for Submission to FDA specifically for Plasma Drug product.Work with cross-functional team to implement and maintain consistency.Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format – Biologics Marketing Applications,and Providing.

Create, review, and approve ANDA and Stability Protocols and nonconformance paperwork in controlled documentation system.Write work instructions, release SOPs, and create forms to establish quality documentation.Develop of matrices for ECOs and complaints and for management review.Work with cross-functional team to implement and maintain consistent.

Summit NJ

Role:Global Regulatory AffairsProvide and implement global CMC regulatory strategy for development projects.Perform annual updates of product Technical File to ensure audit readiness.Lead or contribute to global CMC submission activities (planning, authoring, reviewing, 1coordination, submission) for assigned projects/products, while applying the global.

Master'S Degree, Organic Chemistry

Studied

Msc, Chemistry; Chemistry

I finished my Masters and Bachelors at Osmania University