محمد عامر

Team Leader في Gulf Pharmaceutical Industries (Julphar)

• الإمارات العربية المتحدة - رأس الخيمة
• أشغل هذه الوظيفة منذ مايو 2021

• Supervise the Regulatory Affairs Team for the GCC and Levant region.
• Ensure the timely preparation and processing of documentation required for product registration in applicable markets.
• Manage the preparation of registration dossiers, variation dossiers, and responses to deficiency letters in a timely manner.
• Collaborate and communicate with business partners and regional partners to ensure efficient and timely global product registrations and release.
• Organize and oversee all significant activities potentially related to the Life Cycle Management strategy.
• Evaluate manufacturing and labeling changes, as applicable, to ensure compliance with relevant regulations
• Work collaboratively with other RA staff to ensure consistency of RA inputs and strategies.
• Ensure compliance with GCC region Regulatory requirements.
• Review Change requests and evaluate the regulatory impact on the product in Ample Logic software.
• Prepare error-free eCTD submissions, as per respective Health Authority criteria.

Jr. Manager Regulatory Affairs في Jamjoom Pharmaceuticals Company

• المملكة العربية السعودية - جدة
• ديسمبر 2014 إلى مارس 2021

• Regulatory assessment/gap analysis and suggesting Regulatory Actions to fulfill the noncompliance issues concerning quality and commercial compliance.
• Organize and oversee all significant activities potentially related to the Life Cycle Management strategy.
• Create and maintain submission plans and facilitate the resolution of timeline issues with regulatory and cross-functional team members.
• Prepare error-free eCTD submissions, as per respective Health Authority criteria.
• Prepare variation and renewal packages adhering to the strict deadline as per the guidelines laid by different Global Regulatory Health Authorities.
• Providing key inputs in regulatory strategies development and implementation plans for the post-approval changes/submissions.
• Coordinate and compile documentation for Chemistry Manufacturing Control (CMC) regulatory submissions in support of global marketing applications.
• Manage the preparation of registration packages and responses to deficiency letters in a timely manner.
• Evaluate manufacturing and labeling changes, as applicable, to ensure compliance with relevant regulations.
• Develop and maintain strong internal and external working relationships with relevant Stakeholders.
• Evaluate the received Change requests, from a regulatory point and facilitate regulatory compliance.
• Act as a point of contact for cross‐functional teams and regulatory authorities, company local affiliates, and distributors to ensure that all activities are in compliance.
• Transfer registered data to registration summaries and update of electronic regulatory information system.

Analyst في Accenture Pvt. Ltd

• الهند
• أغسطس 2013 إلى نوفمبر 2014

Control submission content, being accountable for the receipt and workflow completion of all
submission components, resulting in a high-quality final product.
 Conduct issue resolution, communicating with the onshore/client and their functional areas to
ensure that all issues are resolved in a compliant manner.
 Module 3 CMC baseline creation and its life cycle management using client-specific tools such
as PRISM, CARA, and IRIS.
 Perform project management in the absence of the Leads and Manager.
 Perform document-level and final quality control reviews of submission PDF files.
 Rendering multiple documents to PDF, Creation of external links, and compilation of Modules
1-5 in eCTD format.
 Work with the Document Coordinator to find and resolve all submission-related issues.
 Publishing of eCTD, NeeS using publishing tools.
 Participate in the development of internal projects.
 Walk a client through the overall publishing process and an explanation of the publishing tools
and tasks used to produce electronic submissions.

Sr. Executive

• يونيو 2013 إلى أغسطس 2013

Officer في Simpex Pharma Pvt. Ltd

• الهند
• أبريل 2011 إلى مايو 2013

Prepare and review Dossiers for regulatory compliance in CTD format for CIS countries.
 Review and draft OTC product labels for USFDA submission.
 Coordinate and compile documentation for Chemistry Manufacturing Control (CMC)
regulatory submissions in support of global marketing applications.
 Coordinate with Quality Assurance QA, Quality Control QC, Formulation & Development
departments for dossier relevant documents.
 Respond to queries from respective health authorities within predefined time with adequacy
and accuracy.
 Ensuring timely management of license variations and renewals (COPP, FSC, Manufacturing
License, and GMP).