プロフィール詳細

プロジェクトを作成

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Tasmiatul K.に依頼

Australia

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

プロフィール概要

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.

専門分野

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

サービス

• 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

職務経験

Assistant Manager,International Regulatory Affairs

Beximco Pharmaceuticals Ltd

7月 2015 - 現在

Quality Assurance Officer

Beximco Pharmaceuticals Ltd

3月 2011 - 6月 2015

Executive Planning & Procurement

Novus Pharmaceuticals Limited

1月 2010 - 12月 2010

学歴

Bachelor of Pharmacy

University of Development Alternative

9月 2004 - 現在

Masters of Business Administration (MBA)

University of Dhaka, Bangladesh

1月 2013 - 12月 2016

Masters of Pharmaceutical Technology

University of Asia Pacific

9月 2009 - 8月 2010

認定資格

• Introduction to the Medical Technology Industry

  Medical Technology Association of Australia (MTAA)

  10月 2020 - 現在

• Foundations of Public Health

  University at Albany School of Public Health, USA

  9月 2020 - 現在

• EU Medical Device Regulation MDR-2017/745

  Easy Medical Device School, Switzerland

  7月 2020 - 現在

• Drug Development

  University of California San Diego, USA

  7月 2015 - 現在