Waqas Nazir
Summary
Experienced leader with 11 years of experience in the pharmaceutical industry and strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Overview
11
11
years of professional experience
Work History
Regulatory Affairs Manager
Fresenius Kabi Pakistan Pvt Ltd.
06.2021 - 10.2024
- Review of Technical justifications.
- Implementation of 2D barcode system.
- Ensure the implementation of Drug Act Pakistan 1976.
- Ensure the implementation of Health and OTC Act Pakistan.
- Ensure the implementation of DRAP Act 2012.
- Ensure the implementation of Medical Devices Rules 2017.
- Regulatory Intelligence.
- Licensing.
- Registration of products (Pharmaceutical, Medical Device & HOTC) for the local purpose.
- Monitoring of Stringent Regulatory Authorities (USFDA, PMDA Japan, MHRA UK, Health Canada and other 13 countries) recommended by DRAP Pakistan for the registration of products.
- Review of clinical and non-clinical Summaries, Substance data, Product data, clinical Literatures.
- Review of Product Renewals.
- Pricing (CPI, Hardship, NDA).
- Communication with DRAP (Lahore & Islamabad).
- Complied with safety and hazardous material handling, storage regulatory requirements and internal procedures affecting business operations.
- Developed and executed plans to monitor standard process adherence.
- Conducted field visits.
- Documented meeting minutes and distributed to staff to facilitate follow-up and permanent record.
- Managed quality assurance program including on-site evaluations, internal audits, and customer surveys.
- Developed standard operating procedures and document workflows for current and future process steps.
- Possessed expert knowledge of competitive and third-party products and translated knowledge into business strategy.
Regulatory Affairs Leads
Amgomed Pharma Pvt Ltd
11.2024 - Current
- Implementation of Drug Act 1976.
- Implementation of DRAP Act 2012.
- Implementation of Quality standards as per ICH.
- Good Understanding of International Regulation like USFDA, EMA, ICH, WHO, PMDA, SFDA.
- Team Leader; currently leading a team of 5 personnel's.
- Good understanding of Pharmaceutical knowledge.
- Good command on Drug Laws and Regulation.
- Good Liaison with Government departments specially DRAP.
- Skilled at working independently and collaboratively in a team environment.
- Acted as a team leader in group projects, delegating tasks and providing feedback.
- Review and approve the CTD (M1 to M5) , eCTD, CMC, Clinical literatures for submission.
- Meetings with Government officials.
- Developed and maintained courteous and effective working relationships.
- Passionate about learning and committed to continual improvement.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Paid attention to detail while completing assignments.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Exercised leadership capabilities by successfully motivating and inspiring others.
- Identified issues, analyzed information and provided solutions to problems.
- Worked flexible hours across night, weekend, and holiday shifts.
Assistant Manager Regulatory Affairs
Dyson Laboratories Ltd
10.2020 - 06.2021
- Review of Technical/Medical Writing (Justification regarding products if required by the Health Ministry, Training Modules for Market teams regarding the product, Clinical Literatures of Products, inter-departmental communication regarding stability data, analytical validation data, process validation data, pharmaceutical development etc.
- Implementation of 2D barcode system.
- Ensure the implementation of Drug Act Pakistan 1976.
- Ensure the implementation of Health and OTC Act Pakistan.
- Ensure the implementation of DRAP Act 2012.
- Regulatory Intelligence.
- Licensing.
- Registration of products for the local and export purpose (CTD/ACTD).
- Regulation of Drug Laws of Importing country for export purposes.
- Monitoring of Stringent Regulatory Authorities (USFDA, PMDA Japan, MHRA UK, Health Canada and other 13 countries) recommended by DRAP Pakistan for the registration of products.
- Review of clinical and non-clinical Summaries, Substance data, Product data, clinical Literatures.
- Review of Product Renewals.
- Pricing.
- Communication with DRAP (Lahore & Islamabad) Contract manufacturing.
- Conducted training and change management processes to improve operations.
- Complied with safety and hazardous material handling, storage regulatory requirements and internal procedures affecting business operations.
- Improved quality processes for increased efficiency and effectiveness.
- Created and managed knowledge base to offer team immediate informational access to products technical Information.
- Investigated and resolved customer complaints to foster satisfaction.
- Developed and executed plans to monitor standard process adherence.
- Conduct field visits.
- Managed quality assurance program including on-site evaluations, internal audits, and customer surveys.
- Developed standard operating procedures and document workflows for current and future process steps.
- Possessed expert knowledge of competitive and third party products and translated knowledge into business strategy.
Regulatory Affair Officer
Highnoon Laboratories Ltd
08.2014 - 01.2016
- Ensure the implementation of Drug Act Pakistan 1976.
- Ensure the implementation of Health and OTC Act Pakistan.
- Ensure the implementation of DRAP Act 2012.
- Regulatory Intelligence.
- Licensing.
- Registration of products for the local and export purpose (CTD/ACTD).
- Regulation of Drug Laws of Importing country for export purposes.
- Monitoring of Stringent Regulatory Authorities (USFDA, PMDA Japan, MHRA UK, Health Canada and other 13 countries) recommended by DRAP Pakistan for the registration of products.
- Preparation of clinical and non-clinical Summaries, Substance data, Product data, clinical Literatures.
- Product Renewals.
- Pricing.
- Communication with DRAP (Lahore & Islamabad).
- Contract manufacturing.
- Technical/Medical Writing (Justification regarding products if required by the Health Ministry, Training Modules for Market teams regarding the product, Clinical Literatures of Products, inter-departmental communication regarding stability data, analytical validation data, process validation data, pharmaceutical development etc.
- Conducted training and change management processes to improve operations.
- Complied with safety and hazardous material handling, storage regulatory requirements and internal procedures affecting business operations.
- Improved quality processes for increased efficiency and effectiveness.
- Created and managed knowledge base to offer team immediate informational access to products technical Information.
- Investigated and resolved customer complaints to foster satisfaction.
- Developed and executed plans to monitor standard process adherence.
- Conducted field visits.
- Documented meeting minutes and distributed to staff to facilitate follow-up and permanent record.
- Managed quality assurance program including on-site evaluations, internal audits, and customer surveys.
- Developed standard operating procedures and document workflows for current and future process steps.
- Possessed expert knowledge of competitive and third party products and translated knowledge into business strategy.
Officer Production
Highnoon Laboratories Ltd
- Evaluated incoming materials and finished products against standards.
- Escalated concerns to management and helped develop and implement effective solutions.
- Trained production team members on how to complete tasks.
- Coordinated production work between shifts by completing checklists and documenting updates.
- Product Manufacturing (Solid section, liquid section, consumer product section).
- Product packaging.
- Self-inspection.
- GMP compliance.
- Technical staff training.
- Implementation of SOPs.
- Product Trails.
- Eliminate causes of non-conformities or other undesirable situations.
Education
Doctor of Pharmacy - Pharmaceutical Sciences, Pharmacology, Drug Laws
University of Lahore
Lahore, PB07.2014
Associate of Science - Biology, Chemistry, Physics
Government College Of Science
Lahore, PB07.2009
Skills
- Drug Laws and regulatory compliance
- Regulatory filing management
- Project manager supervision
- Regulatory Requirements
- Organized managerial style
- Regulatory monitoring
- Regulatory enforcement
- Regulatory understanding
- Regulatory knowledge
- Regulatory guidelines
- Regulatory research
- Regulatory Policies
- Global Regulatory Compliance
- Regulatory Dossiers
- ECTD
- CTD
- Collaboration
- Analytical
- Dependable and responsible
Accomplishments
- Achieved registration of three products within the 7 months by completing all the tasks with accuracy and efficiency.
- Submission of dossier (parenteral nutrition product) with 28 different APIs and successfully registered it within 1 year.
- Total product filings (only submission): 200+ products.
- Total registrations (submission to registration) in career; 20 products.
- Startegic Partnerships.
- Implementation of new projects like 2D Barcode system, Digitalization of the Regulatory department.
-
Personal Information
Title: Pharmacist
Timeline
Regulatory Affairs Leads
Amgomed Pharma Pvt Ltd
11.2024 - Current
Regulatory Affairs Manager
Fresenius Kabi Pakistan Pvt Ltd.
06.2021 - 10.2024
Assistant Manager Regulatory Affairs
Dyson Laboratories Ltd
10.2020 - 06.2021
Regulatory Affair Officer
Highnoon Laboratories Ltd
08.2014 - 01.2016
Officer Production
Highnoon Laboratories Ltd
Associate of Science - Biology, Chemistry, Physics
Government College Of Science
Doctor of Pharmacy - Pharmaceutical Sciences, Pharmacology, Drug Laws
University of Lahore
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