Quality Assurance Regulatory Affairs

Mohammed Nooruzzaman

Address: **** ***** **, ****** *******, NY 11427

E-mail: adyxil@r.postjobfree.com

Tel: 646-***-****

Background

• A pharmacy Graduate with a Master's in Drug Regulatory Affairs and Pharmaceutical Quality Assurance.

• Experience in Regulatory Affairs & Quality Assurance (Pharmaceutical) and Regulatory & Medical Writing (Medical Devices)

Work Experience:

Regulatory Specialist (Regulatory & Medical Writing Services) NAMSA (Medical Research Organization) - Greenwich, NY December 2019 – July 2023.

Regulatory:

• Assists in developing Clinical Evaluation Plans and Reports (MEDDEV 2.7.1/rev. 4 and EU MDR). Authored multiple Clinical Evaluation Reports per EU MDR 2017/745 (considering MDCG guidance documents) and MEDDEV 2.7/1 Rev 4, covering a variety of strategies (such as non-clinical route per MDR article 61, section 10, and well-established technology), including: o Summary and analysis of customer feedback/survey data, complaint data, and Health Authority Reports (MDR and MDV Report).

o Supported team for CSR (Clinical Study Report) and PSUR ( Perodic Safety Update Report). o Review and presentation of data on current market status, significant device changes/proposed changes, CAPA, ADE, DPRA, FSA, TF, FAR, post-market experience, recall o Review and presentation of data of user information, including intended indication, contraindication, warning, precautions, and device claim information. o Review and presentation of data from pre-clinical studies and clinical investigations. Medical Writing

• Performing systemic literature reviews using the PRISMA guidelines.

• Analysis of safety and performance outcome data from the literature for meta-analysis.

• Literature review for State of the Art/Current Knowledge section. Associate-IV, Regulatory Affairs

Fougera Pharmaceuticals Inc. (A Novartis Company- Sandoz Generic Division) - Melville, NY June 2015 to April 2019

• Prepare, review, and submit high-quality regulatory submissions, including ANDAs, amendments, supplements, annual reports, and additional documents as needed to the FDA within company timelines and per regulatory guidelines and applicable federal laws.

• For FDA submissions, compile and review ANDAs, INDs, NDAs, amendments, supplements, annual reports, control documents, etc.

• Prepare timely responses to FDA Regulatory Inquires and Complete Response letters.

• Act as liaison with FDA for follow-up and negotiations on applications.

• Review and confirm the accuracy of the information for regulatory submissions.

• Review and Approval of analytical procedures and specifications, formulations, manufacturing instructions, filing instructions, and component changes in Track Wise and Documentum systems.

• Prepare and Submit CBE-0, CBE-30, and PAS (Prior Approval Supplement) for CMC and Labeling changes.

• Review Raw Material, Dug Substance, Finished product, and stability specification in LIMS.

• Review and provide recommendations on clinical and stability protocols.

• Review and approve regulatory documentation for clinical drug shipments.

• Interact effectively with functional business units to obtain technical and clinical information/ documentation and analyze for compliance with current regulations.

• Prepare END User Letters per Procurement Department for incoming API and FDF shipments as needed.

• Monitor and investigate daily federal register, FDA internet updates, and trade press notices for regulations or regulatory policy changes that may impact internal operations.

• Review and Approval in Track Wise for all labeling changes, promotional literature, changes related to RLD updates, and SPL updates and submit supplements for regulatory compliance.

• Review and approve FDA-mandated Track and Trace (Serialization) labeling changes for all products. Quality Assurance and Regulatory Compliance (APR and AR) Administrator Sun Pharmaceutical Inc - Cranbury, NJ

October 2012 to May 2015

• Publish, monitor, and maintain the APR/AR schedules.

• Review the executed Manufacturing and Packaging Batch Records.

• Audit QC released report for completeness and compliance with the specifications.

• Collect, summarize, and trend the data using statistical tools.

• Collect, summarize, and trend the associated investigations, change controls, equipment maintenance history, and stability data.

• Prepare the executive summary and construct the APR for the product with conclusions.

• Circulate the compiled APR for management review, and coordinate for review and Approval of the APRs to meet the expected APR completion due dates.

• Assist in initiating CAPA for the observed trends, management notifications, and monitoring of the CAPAs.

• Support the site during FDA inspections.

• Issuance and archival of the documents and other tasks assigned by the management. Review and prepare the following section of the AR (Annual Report) to be submitted to FDA: -

• Summary of New Information (Change controls related to API & Excipients, Analytical Test Method, BMR, PMR, Stability Protocol)

• Log of Outstanding Regulatory Business

• Distribution Data

• Labeling changes

• Chemistry, Manufacturing, and Controls

• Stability Study Report

Regulatory Affairs Associate

Global Regulatory Support Inc - Township of South Brunswick, NJ June 2011 to September 2012

• Providing support to plan, prepare, and review various ANDA submissions in ecad format.

• Prepare a submission for marketed products, i.e., Amendments, Supplement, Annual Reports, and Periodic Safety Reports per FDA regulations.

• Review relevant technical documents such as Change Control, Method Transfers, Batch Record Documentation, Validation, and Reports as needed.

• Develop new labeling packaging components for submissions to FDA. Supervisor, Quality Assurance

Kabco Pharmaceutical Inc - Amityville, NY

January 2005 to May 2011

• Review and approve all documents, including batch records, standard operating procedures, specifications, analytical procedures, protocols, reports, and other quality records to ensure compliance with cGMP regulations.

• Review and approve SOP as per the FDA and ICH requirements.

• Review and approve analytical laboratory reports for raw materials, stability, In-Process, and Finished Products.

• Review and approve artwork/labeling updates from a technical and claims perspective.

• Review and approve specifications for container and closure system.

• Review and approve internal audit reports.

• Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans.

• Evaluate, Review, and approve all change controls.

• Provide internal training, such as GMP training, SOP training sessions, and new regulatory guidance.

• Education

• Masters in Drug Regulatory Affairs:

Long Island University - Brooklyn, NY

• Master of Pharmacy(M.Pharm):

University of Dhaka, Bangladesh

• Bachelor of Pharmacy(B.Pharm):

University of Dhaka, Bangladesh

Computer Skills:

• Proficient in MS Word, Excel, and PowerPoint.

• LIMS, Track Wise, SAP, SELS, Spirit, Documentum System, SPSS, and Minitab. Membership:

• RAPS (Regulatory Affairs Professional Society)

• BAPA (Bangladeshi American Pharmacist Association).

• ABPS (American Association of Bangladeshi Pharmaceutical Scientists) Language Skills:

• English

• Bangla

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