Profile Details

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USD 90 /hr

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Hire Tasmiatul K.

Australia

USD 90 /hr

B. Pharm, M. Pharm, PGDIM, MBA (DU), QA and Regulatory Specialist of Medicinal Products

Profile Summary

1. Registered and Licensed Pharmacist (RPh) in Bangladesh (Reg. No- A 4845) 2. Experienced Professional equipped with skills in the field of Regulatory, Pharmacovigilance, Quality assurance, GMP and Safety. 3. In depth Knowledge of USFDA (USA), TGA (Australia), Health Canada, EMEA (Europe), SAPHRA (South Africa), SDAC (Africa), GCC (GULF countries), ASEAN (Asia) regulatory requirements in the registration of pharmaceuticals, food supplements, complementary medicine and medical device, marketing authorization and licenses. 4. Worked with different regulatory authorities to prepare and evaluate pharmaceutical dossiers and submission process for registration. 5. Conduct GMP audit in liaison with different regulatory authority.

Subject Matter Expertise

• ★ Regulatory Affairs
• ★ Product Compliance
• ☆ European Medical Device Regulation (MDR)
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Technical Writing

Research Market Research, Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis

Product Development Formulation, Stability/Shelf Life Testing

Work Experience

Assistant Manager,International Regulatory Affairs

Beximco Pharmaceuticals Ltd

July 2015 - Present

Quality Assurance Officer

Beximco Pharmaceuticals Ltd

March 2011 - June 2015

Executive Planning & Procurement

Novus Pharmaceuticals Limited

January 2010 - December 2010

Education

Bachelor of Pharmacy

University of Development Alternative

September 2004 - Present

Masters of Business Administration (MBA)

University of Dhaka, Bangladesh

January 2013 - December 2016

Masters of Pharmaceutical Technology

University of Asia Pacific

September 2009 - August 2010

Certifications

• Introduction to the Medical Technology Industry

  Medical Technology Association of Australia (MTAA)

  October 2020 - Present

• Foundations of Public Health

  University at Albany School of Public Health, USA

  September 2020 - Present

• EU Medical Device Regulation MDR-2017/745

  Easy Medical Device School, Switzerland

  July 2020 - Present

• Drug Development

  University of California San Diego, USA

  July 2015 - Present