regulatory affairs coordinator

Peergrowth Consultancy Co.

<p>We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at our UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including support for GMP audits. The ideal candidate will collaborate closely with Quality Assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams. Experience with local UAE and GCC regulatory requirements is preferred, with an understanding of global CTD requirements.</p><p><b>KEY RESPONSIBILITIES</b></p><ul><li>Collate, compile, and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.</li><li>Ensure accuracy, completeness, and regulatory compliance of all documentation submitted.</li><li>Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.</li><li>Act as a key liaison between regional regulatory teams and site-based technical functions (QA, QC, Production, Engineering).</li><li>Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.</li><li>Maintain an organized and up-to-date archive of all regulatory submissions made from the site.</li><li>Implement proper version control, submission tracking, and document retrieval protocols.</li><li>Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.</li><li>Ensure alignment with both international regulatory expectations and local UAE / GCC requirements.</li><li>Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.</li><li>Support documentation requests for internal audits, inspections, and compliance reviews.</li></ul><p><b>CANDIDATE EXPERIENCE</b></p><ul><li>Bachelors or masters degree in pharmacy (preferred)</li><li>2 to5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry.</li><li>Preferred : Experience with handling guidelines of UAE Ministry of Health (MoHAP), GCC-DR, Oman, Bahrain, or other Gulf regulatory bodies.</li><li>Practical knowledge of CTD / eCTD dossier formats and GMP audit preparation.</li></ul><p><b>Key Skills and Competencies</b></p><ul><li>Strong communication, collaboration, and coordination skills across technical and regulatory functions.</li><li>High level of accuracy, attention to detail, and document management capabilities.</li><li>Ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements.</li><li>Proficient in Microsoft Office (Word, Excel, PowerPoint) and document control systems.</li><li>Proactive approach to problem-solving and handling regulatory queries.</li></ul><p>Coordinator • Dubai, United Arab Emirates</p>

Regulatory Affairs Coordinator

IQVIA

<div><p><i>Advance healthcare with IQVIA &ndash; where your expertise drives innovation and compliance.</i></p><p></p><p><b>
About the Role</b></p><p><br>
As a Senior Regulatory Affairs Coordinator at IQVIA, you will play a critical role in ensuring regulatory compliance and supporting submissions of Cosmetics, Nutritional Products, and Medical Devices across Egypt and GCC. You&rsquo;ll collaborate with internal teams and health authorities to maintain the highest standards of documentation and process excellence.</p><p></p><p><b>
Key Responsibilities</b></p><ul><li>
Prepare, review, and organize regulatory documentation in line with IQVIA and health authority standards.</li><li>
Support timely submissions through Health Authority systems and maintain accurate records.</li><li>
Act as a liaison between clients and regulatory bodies, ensuring clear and effective communication.</li><li>
Identify opportunities for process improvement and contribute to best practices.</li><li>
Uphold quality and safety standards across all deliverables.</li></ul><p></p><p><b>
Qualifications</b></p><ul><li>
Bachelor&rsquo;s degree in Pharmaceutical Science or related field.</li><li>
Minimum 1 year of experience in Regulatory Affairs (Cosmetics and Nutritional Products) within Egypt or GCC; experience with medical devices is a plus.</li><li>
Strong knowledge of good documentation practices and proficiency in HA systems and Microsoft tools.</li><li>
Excellent organizational, communication, and problem-solving skills.</li><li>
Fluency in local language and good command of English.</li><li>
Ability to manage multiple priorities with attention to detail.</li></ul><p></p><p><b>
Why IQVIA?</b><br>
At IQVIA, you&rsquo;ll be part of a global team that pushes the boundaries of science and technology to improve healthcare worldwide. We offer continuous learning, career growth, and the opportunity to make an impact that matters.</p><p></p><p><b>
Ready to make a difference?</b><br>
Apply now and join IQVIA&rsquo;s mission to advance human health.</p><p></p><p>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</p></div>

Senior Regulatory Affairs Coordinator

Pfizer

<div><div>JOB SUMMARY</div><div>
Vault RIM process and system is highly dependent on accurate &amp; complete metadata at all levels and there is also an increasing amount of data that Health Authorities are requiring to be tracked and submitted.
</div><div>The Regulatory Data Coordinator is responsible for driving key &amp; critical activities within V-RIM in support of enabling the assessment and subsequent management of new or required changes (system events).</div><div>
They will specifically review all events initiated across the product lifecycle, completing system impact assessments, and creating Activities, Regulatory Objectives, Submissions to enable GRS to take the necessary actions. The Coordinator also ensures that Event Details, Change Items &amp; Label Concepts are associated and have the appropriate details as well as creating the Global Content Plan in readiness for content authoring across the enterprise.</div><div>
The Coordinator will work with the CMC Product strategist(s), labeling leads, Clinical &amp; Country Regulatory Strategists through a mix of strategic and operational support, demanding a detailed understanding of regulatory system structures, product licences &amp; master data as well as the end-to-end regulatory change management experience within &amp; across domains.</div><div></div><div>
JOB RESPONSIBILITIES</div><ul><li>
Management of all related RIM events and their related records, including event details and registered details &ndash; ensuring structures and relationships enable accurate reflection of the product market registration while still aligning to master data, and ensuring maintenance in alignment with agency decisions
</li><li>HA Decision/Interaction management: Interpreting communications and drive appropriate actions to update system (and potentially notify stakeholders even if accountability for that remains with the Reg Strategist), collaborating with Stakeholders across GRS &amp; CMC strategists, PGS, and other teams to understand data requirements and ensure data needs are met</li><li>
Review and Approve Data Changes: Evaluate and approve data change requests, ensuring compliance with data governance policies</li><li>
Active Dossier Management: Ensuring maintenance across the lifecycle, including in alignment with agency decisions
</li><li>Provide Training and Support: Train &amp; support business users on data quality standards and data &amp; process management best practices</li><li>
Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum process in support of products through the development and commercial Lifecyle of a drug</li><li>
Ensure escalations, business process &amp; solution achieves business needs</li><li>
Evolve service based on strategic objectives &ndash; efficiency / quality drivers</li></ul><div></div><div>
Typical Tasks:</div><ul><li>
Collaboration and Communication: Work closely with business units, IT, and other stakeholders to understand data requirements and support data-related initiatives. Lead data review/update meetings Provide guidance and support to system users through an advanced understanding</li><li>
Notifications and Reporting: Ensure that notifications are sent to relevant stakeholders upon completion of data updates. Generate reports on data quality, data requests, and other relevant metrics</li><li>
Review Event Information: Ensure understanding of the event's purpose and scope. Interpret and understand the change items to ensure appropriate event details are updated to enable proper impact assessments and GPC structure to be created</li><li>
Create Event Details: Use the wizard to create event details, selecting appropriate actions and fields</li><li>
Run Impact Assessment Report: Generate the report to identify impacted registrations</li><li>
Create Related Records: Use the wizard to create activities and other related records based on the impact assessment report. Verify the records created by the wizard and confirm their accuracy. Check for any discrepancies and ensure all data is correctly entered and linked</li><li>
Facilitates delivery and approval of Pfizer electronic and paper regulatory submissions through co-ordination and execution of CMC components to unique requirements and standards of each submission and national market</li><li>
Through active management of status and expected deliverables, identifies risks and partners with regulatory strategists and relevant stakeholders to mitigate risks to quality and timeliness of CMC changes while ensuring status is accurately reflected at all times through maintenance of metadata in regulatory workflow and/or document management system(s)</li><li>
Develops ideas and leads/co-leads complex projects across RIO, G&amp;IPE &amp; GRS.</li><li>
Develops and manages plans to achieve objectives</li><li>
Applies skills and discipline knowledge to contribute to the achievement of work within Sub Business Unit/Sub Operating Unit</li><li>
Makes decisions that require developing innovative options to resolve complex problems</li><li>
Makes decisions within general business line or functional guide</li><li>
Leads operational team(s) within and across Work Teams and Departments</li><li>
Involvement in visible and timebound complex and/or high volume projects with pan regional impact with challenging constraints.</li></ul><div></div><div>
ORGANIZATIONAL RELATIONSHIPS</div><ul><li>
Regulatory Strategy, CMC leads, Clinical, Non-Clinical, Data Coordinators, RIO, Digital</li><li>
Will work in a highly matrixed environment and in close collaboration with Operations and Strategy.</li></ul><div></div><div>
RESOURCES MANAGED</div><ul><li>
Project specific resources &amp; vendor staff</li></ul><div></div><div>
QUALIFICATIONS/SKILLS</div><ul><li>
Bachelor&rsquo;s or Master&rsquo;s degree in Life Sciences, Regulatory Affairs, Data Management, or related field</li><li>
6+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3 years in a data governance, data management, or data quality role</li><li>
Significant experience with master data management and data quality improvement</li><li>
E2E global regulatory change management experience, including change initiation, performing impact assessments, submission to HA and management of HA decisions/queries/interactions/commitments
</li><li>Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs and support compliance</li><li>
Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling</li><li>
Detailed understanding of GRS roles/responsibilities related to dossier maintenance and submissions
</li><li>Strong understanding of data governance principles and best practices</li><li>
Experience with master data management and data quality improvement</li><li>
Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards</li><li>
Strong communication and collaboration skills</li><li>
Attention to detail and commitment to data accuracy and integrity</li></ul><div></div><div>
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</div><div></div>
Regulatory Affairs</div><div></div>

Regulatory Data Coordinator, Sr. Manager

<div>
 <strong>
  Job Summary
  <br/>
  <br/>
 </strong>
 Vault RIM process and system is highly dependent on accurate &amp; complete metadata at all levels and there is also an increasing amount of data that Health Authorities are requiring to be tracked and submitted.
 <br/>
 <br/>
 The Regulatory Data Coordinator is responsible for driving key &amp; critical activities within V-RIM in support of enabling the assessment and subsequent management of new or required changes (system events).
 <br/>
 <br/>
 They will specifically review all events initiated across the product lifecycle, completing system impact assessments, and creating Activities, Regulatory Objectives, Submissions to enable GRS to take the necessary actions. The Coordinator also ensures that Event Details, Change Items &amp; Label Concepts are associated and have the appropriate details as well as creating the Global Content Plan in readiness for content authoring across the enterprise.
 <br/>
 <br/>
 The Coordinator will work with the CMC Product strategist(s), labeling leads, Clinical &amp; Country Regulatory Strategists through a mix of strategic and operational support, demanding a detailed understanding of regulatory system structures, product licences &amp; master data as well as the end-to-end regulatory change management experience within &amp; across domains.
 <br/>
 <br/>
 <strong>
  Job Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Management of all related RIM events and their related records, including event details and registered details &ndash; ensuring structures and relationships enable accurate reflection of the product market registration while still aligning to master data, and ensuring maintenance in alignment with agency decisions .
  </li>
  <li>
   HA Decision/Interaction management: Interpreting communications and drive appropriate actions to update system (and potentially notify stakeholders even if accountability for that remains with the Reg Strategist) , collaborating with Stakeholders across GRS &amp; CMC strategists, PGS, and other teams to understand data requirements and ensure data needs are met.
  </li>
  <li>
   Review and Approve Data Changes: Evaluate and approve data change requests, ensuring compliance with data governance policies.
  </li>
  <li>
   Active Dossier Management: Ensuring maintenance across the lifecycle, including in alignment with agency decisions
  </li>
  <li>
   Provide Training and Support: Train &amp; support business users on data quality standards and data &amp; process management best practices.
  </li>
  <li>
   Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum process in support of products through the development and commercial Lifecyle of a drug
  </li>
  <li>
   Ensure escalations, business process &amp; solution achieves business needs
  </li>
  <li>
   Evolve service based on strategic objectives &ndash; efficiency / quality drivers
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Typical Tasks:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Collaboration and Communication: Work closely with business units, IT, and other stakeholders to understand data requirements and support data-related initiatives. Lead data review/update meetings. Provide guidance and support to system users through an advanced understanding.
  </li>
  <li>
   Notifications and Reporting: Ensure that notifications are sent to relevant stakeholders upon completion of data updates. Generate reports on data quality, data requests, and other relevant metrics.
  </li>
  <li>
   Review Event Information: Ensure understanding of the event's purpose and scope. Interpret and understand the change items to ensure appropriate event details are updated to enable proper impact assessments and GPC structure to be created.
  </li>
  <li>
   Create Event Details: Use the wizard to create event details, selecting appropriate actions and fields.
  </li>
  <li>
   Run Impact Assessment Report: Generate the report to identify impacted registrations.
  </li>
  <li>
   Create Related Records: Use the wizard to create activities and other related records based on the impact assessment report. Verify the records created by the wizard and confirm their accuracy. Check for any discrepancies and ensure all data is correctly entered and linked.
  </li>
  <li>
   Facilitates delivery and approval of Pfizer electronic and paper regulatory submissions through co-ordination and execution of CMC components to unique requirements and standards of each submission and national market.
  </li>
  <li>
   Through active management of status and expected deliverables, identifies risks and partners with regulatory strategists and relevant stakeholders to mitigate risks to quality and timeliness of CMC changes while ensuring status is accurately reflected at all times through maintenance of metadata in regulatory workflow and/or document management system(s).
  </li>
  <li>
   Provides guidance to and/or may lead/co-lead moderately complex projects
  </li>
  <li>
   Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Department
  </li>
  <li>
   Applies skills and discipline knowledge to contribute to the achievement of work within Department
  </li>
  <li>
   Makes decisions that may require developing new options to resolve moderately complex problems
  </li>
  <li>
   Makes decisions guided by policies in non-standard situations
  </li>
  <li>
   Regularly takes informal leadership role during Work Team meetings to facilitate agreements and move the Work Team toward its goals
  </li>
  <li>
   Acts as a subject matter expert with extensive regulatory, system &amp; process expertise working in close matrix collaboration with strategists and other local and above country cross-functional stakeholders.
  </li>
  <li>
   Represents the RIO function and plays key roles in RIO, GI&amp;PE and GRS improvement projects
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  ORGANIZATIONAL RELATIONSHIPS
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Regulatory Strategy, CMC leads, Clinical, Non-Clinical, Data Coordinators, RIO, Digital
  </li>
  <li>
   Will work in a highly matrixed environment and in close collaboration with Operations and Strategy.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  RESOURCES MANAGED
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Project specific resources &amp; vendor staff
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications / Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s or Master&rsquo;s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.
  </li>
  <li>
   4+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3 years in a data governance, data management, or data quality role.
  </li>
  <li>
   Product lead/support experience, including management of product/registration information in systems
  </li>
  <li>
   E2E global regulatory change management experience, including change initiation, performing impact assessments, submission to HA and management of HA decisions/queries/interactions/commitments
  </li>
  <li>
   Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs and support compliance
  </li>
  <li>
   Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling
  </li>
  <li>
   Detailed understanding of GRS roles/responsibilities related to dossier maintenance and submissions
  </li>
  <li>
   Strong understanding of data governance principles and best practices.
  </li>
  <li>
   Experience with master data management and data quality improvement.
  </li>
  <li>
   Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
  </li>
  <li>
   Strong communication and collaboration skills.
  </li>
  <li>
   Attention to detail and commitment to data accuracy and integrity.
   <br/>
   <br/>
  </li>
 </ul>
 Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
 <br/>
 <br/>
 Regulatory Affairs
</div>


Regulatory Data Coordinator, Manager

<div><div><div><div>JOB SUMMARY</div><div>
Vault RIM process and system is highly dependent on accurate &amp; complete metadata at all levels and there is also an increasing amount of data that Health Authorities are requiring to be tracked and submitted.
</div><div>The Regulatory Data Coordinator is responsible for driving key &amp; critical activities within V-RIM in support of enabling the assessment and subsequent management of new or required changes (system events).</div><div>
They will specifically review all events initiated across the product lifecycle, completing system impact assessments, and creating Activities, Regulatory Objectives, Submissions to enable GRS to take the necessary actions. The Coordinator also ensures that Event Details, Change Items &amp; Label Concepts are associated and have the appropriate details as well as creating the Global Content Plan in readiness for content authoring across the enterprise.</div><div>
The Coordinator will work with the CMC Product strategist(s), labeling leads, Clinical &amp; Country Regulatory Strategists through a mix of strategic and operational support, demanding a detailed understanding of regulatory system structures, product licences &amp; master data as well as the end-to-end regulatory change management experience within &amp; across domains.</div><div></div><div>
JOB RESPONSIBILITIES</div><ul><li>
Management of all related RIM events and their related records, including event details and registered details &ndash; ensuring structures and relationships enable accurate reflection of the product market registration while still aligning to master data, and ensuring maintenance in alignment with agency decisions.</li><li>
HA Decision/Interaction management: Interpreting communications and drive appropriate actions to update system (and potentially notify stakeholders even if accountability for that remains with the Reg Strategist), collaborating with Stakeholders across GRS &amp; CMC strategists, PGS, and other teams to understand data requirements and ensure data needs are met.</li><li>
Review and Approve Data Changes: Evaluate and approve data change requests, ensuring compliance with data governance policies.</li><li>
Active Dossier Management: Ensuring maintenance across the lifecycle, including in alignment with agency decisions
</li><li>Provide Training and Support: Train &amp; support business users on data quality standards and data &amp; process management best practices.</li><li>
Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum process in support of products through the development and commercial Lifecyle of a drug</li><li>
Ensure escalations, business process &amp; solution achieves business needs</li><li>
Evolve service based on strategic objectives &ndash; efficiency / quality drivers</li></ul><div></div><div>
Typical Tasks:</div><ul><li>
Collaboration and Communication: Work closely with business units, IT, and other stakeholders to understand data requirements and support data-related initiatives. Lead data review/update meetings. Provide guidance and support to system users through an advanced understanding.</li><li>
Notifications and Reporting: Ensure that notifications are sent to relevant stakeholders upon completion of data updates. Generate reports on data quality, data requests, and other relevant metrics.</li><li>
Review Event Information: Ensure understanding of the event's purpose and scope. Interpret and understand the change items to ensure appropriate event details are updated to enable proper impact assessments and GPC structure to be created.</li><li>
Create Event Details: Use the wizard to create event details, selecting appropriate actions and fields.</li><li>
Run Impact Assessment Report: Generate the report to identify impacted registrations.</li><li>
Create Related Records: Use the wizard to create activities and other related records based on the impact assessment report. Verify the records created by the wizard and confirm their accuracy. Check for any discrepancies and ensure all data is correctly entered and linked.</li><li>
Facilitates delivery and approval of Pfizer electronic and paper regulatory submissions through co-ordination and execution of CMC components to unique requirements and standards of each submission and national market.</li><li>
Through active management of status and expected deliverables, identifies risks and partners with regulatory strategists and relevant stakeholders to mitigate risks to quality and timeliness of CMC changes while ensuring status is accurately reflected at all times through maintenance of metadata in regulatory workflow and/or document management system(s).</li><li>
Provides guidance to and/or may lead/co-lead moderately complex projects</li><li>
Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Department</li><li>
Applies skills and discipline knowledge to contribute to the achievement of work within Department</li><li>
Makes decisions that may require developing new options to resolve moderately complex problems</li><li>
Makes decisions guided by policies in non-standard situations</li><li>
Regularly takes informal leadership role during Work Team meetings to facilitate agreements and move the Work Team toward its goals</li><li>
Acts as a subject matter expert with extensive regulatory, system &amp; process expertise working in close matrix collaboration with strategists and other local and above country cross-functional stakeholders.</li><li>
Represents the RIO function and plays key roles in RIO, GI&amp;PE and GRS improvement projects</li></ul><div></div><div>
ORGANIZATIONAL RELATIONSHIPS</div><ul><li>
Regulatory Strategy, CMC leads, Clinical, Non-Clinical, Data Coordinators, RIO, Digital</li><li>
Will work in a highly matrixed environment and in close collaboration with Operations and Strategy.</li></ul><div></div><div>
RESOURCES MANAGED</div><ul><li>
Project specific resources &amp; vendor staff</li></ul><div></div><div>
QUALIFICATIONS / SKILLS</div><ul><li>
Bachelor&rsquo;s or Master&rsquo;s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.</li><li>
4+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3 years in a data governance, data management, or data quality role.</li><li>
Product lead/support experience, including management of product/registration information in systems
</li><li>E2E global regulatory change management experience, including change initiation, performing impact assessments, submission to HA and management of HA decisions/queries/interactions/commitments
</li><li>Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs and support compliance</li><li>
Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling</li><li>
Detailed understanding of GRS roles/responsibilities related to dossier maintenance and submissions
</li><li>Strong understanding of data governance principles and best practices.</li><li>
Experience with master data management and data quality improvement.</li><li>
Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.</li><li>
Strong communication and collaboration skills.</li><li>
Attention to detail and commitment to data accuracy and integrity.</li></ul></div></div><div></div><div>
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</div><div></div>
Regulatory Affairs</div><div></div>

<div><div>JOB SUMMARY</div><div>
Vault RIM process and system is highly dependent on accurate &amp; complete metadata at all levels and there is also an increasing amount of data that Health Authorities are requiring to be tracked and submitted.
</div><div>The Regulatory Data Coordinator is responsible for driving key &amp; critical activities within V-RIM in support of enabling the assessment and subsequent management of new or required changes (system events).</div><div>
They will specifically review all events initiated across the product lifecycle, completing system impact assessments, and creating Activities, Regulatory Objectives, Submissions to enable GRS to take the necessary actions. The Coordinator also ensures that Event Details, Change Items &amp; Label Concepts are associated and have the appropriate details as well as creating the Global Content Plan in readiness for content authoring across the enterprise.</div><div>
The Coordinator will work with the CMC Product strategist(s), labeling leads, Clinical &amp; Country Regulatory Strategists through a mix of strategic and operational support, demanding a detailed understanding of regulatory system structures, product licences &amp; master data as well as the end-to-end regulatory change management experience within &amp; across domains.</div><div></div><div>
JOB RESPONSIBILITIES</div><ul><li>
Management of all related RIM events and their related records, including event details and registered details &ndash; ensuring structures and relationships enable accurate reflection of the product market registration while still aligning to master data, and ensuring maintenance in alignment with agency decisions.</li><li>
HA Decision/Interaction management: Interpreting communications and drive appropriate actions to update system (and potentially notify stakeholders even if accountability for that remains with the Reg Strategist), collaborating with Stakeholders across GRS &amp; CMC strategists, PGS, and other teams to understand data requirements and ensure data needs are met.</li><li>
Review and Approve Data Changes: Evaluate and approve data change requests, ensuring compliance with data governance policies.</li><li>
Active Dossier Management: Ensuring maintenance across the lifecycle, including in alignment with agency decisions
</li><li>Provide Training and Support: Train &amp; support business users on data quality standards and data &amp; process management best practices.</li><li>
Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum process in support of products through the development and commercial Lifecyle of a drug</li><li>
Ensure escalations, business process &amp; solution achieves business needs</li><li>
Evolve service based on strategic objectives &ndash; efficiency / quality drivers</li></ul><div></div><div>
Typical Tasks:</div><ul><li>
Collaboration and Communication: Work closely with business units, IT, and other stakeholders to understand data requirements and support data-related initiatives. Lead data review/update meetings. Provide guidance and support to system users through an advanced understanding.</li><li>
Notifications and Reporting: Ensure that notifications are sent to relevant stakeholders upon completion of data updates. Generate reports on data quality, data requests, and other relevant metrics.</li><li>
Review Event Information: Ensure understanding of the event's purpose and scope. Interpret and understand the change items to ensure appropriate event details are updated to enable proper impact assessments and GPC structure to be created.</li><li>
Create Event Details: Use the wizard to create event details, selecting appropriate actions and fields.</li><li>
Run Impact Assessment Report: Generate the report to identify impacted registrations.</li><li>
Create Related Records: Use the wizard to create activities and other related records based on the impact assessment report. Verify the records created by the wizard and confirm their accuracy. Check for any discrepancies and ensure all data is correctly entered and linked.</li><li>
Facilitates delivery and approval of Pfizer electronic and paper regulatory submissions through co-ordination and execution of CMC components to unique requirements and standards of each submission and national market.</li><li>
Through active management of status and expected deliverables, identifies risks and partners with regulatory strategists and relevant stakeholders to mitigate risks to quality and timeliness of CMC changes while ensuring status is accurately reflected at all times through maintenance of metadata in regulatory workflow and/or document management system(s).</li><li>
Contributes to the completion of moderately complex projects</li><li>
Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team</li><li>
Applies skills and discipline knowledge to contribute to the achievement of work within Work Team</li><li>
Makes decisions to resolve moderately complex problems in standard situations</li><li>
Makes decisions within guidelines and policies</li><li>
Participates and contributes as a team member</li></ul><div></div><div>
ORGANIZATIONAL RELATIONSHIPS</div><ul><li>
Regulatory Strategy, CMC leads, Clinical, Non-Clinical, Data Coordinators, RIO, Digital</li><li>
Will work in a highly matrixed environment and in close collaboration with Operations and Strategy.</li></ul><div></div><div>
RESOURCES MANAGED</div><ul><li>
Project specific resources &amp; vendor staff</li></ul><div></div><div>
QUALIFICATIONS / SKILLS</div><ul><li>
B.S./B.Scs. is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.</li><li>
2+ years of experience in regulatory, data management, data governance, or a related role within the pharmaceutical or healthcare industry.</li><li>
E2E global regulatory change management experience, including change initiation, performing impact assessments, submission to HA and management of HA decisions/queries/interactions/commitments
</li><li>Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs and support compliance</li><li>
Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling</li><li>
Detailed understanding of GRS roles/responsibilities related to dossier maintenance and submissions
</li><li>Strong understanding of data governance principles and best practices.</li><li>
Experience with master data management and data quality improvement.</li><li>
Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.</li><li>
Strong communication and collaboration skills.</li><li>
Attention to detail and commitment to data accuracy and integrity.</li></ul><div></div><div>
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</div><div></div>
Regulatory Affairs</div><div></div>

Regulatory Data Coordinator, Senior Associate

Accure Medical Pvt Ltd

<p><b>Position: Management Trainee &ndash; Regulatory Affairs (Medical Devices) </b></p><p><b>Experience:</b> 0&ndash;2 Years<br/><b>Location:</b> Noida sec-63</p><p><b>Vacancy:</b> 1</p><p>Salary: 12k-15k/month</p><p><b>Role Overview</b></p><p>The Management Trainee &ndash; Regulatory Affairs (Medical Devices) will assist senior regulatory professionals in handling certification, licensing, and compliance activities. The role is ideal for fresher or candidates with up to 2 years of experience who are eager to build a career in regulatory affairs within the medical device / pharmaceutical industry.</p><p><b>Key Responsibilities</b></p><ul><li>Assist senior regulatory team members in <b>certification and licensing processes</b> (CE, CDSCO, ISO, BIS, etc.)</li><li>Support preparation, compilation, and submission of <b>regulatory documents, applications</b></li><li>Coordinate with notified bodies, consultants, and government authorities for approvals and renewals</li><li>Maintain and update <b>regulatory records, certificates, and compliance databases</b></li><li>Track timelines for license validity, renewals, and surveillance audits</li><li>Support internal and external audits by providing required documentation</li><li>Assist in reviewing product labels, IFUs, and packaging for regulatory compliance</li><li>Stay updated with changes in <b>regulatory guidelines and standards</b></li><li>Perform any other regulatory-related tasks assigned by seniors</li></ul><p><b>Desired Candidate Profile</b></p><ul><li>Bachelor&rsquo;s degree in <b>Life Sciences, Pharmacy, Biomedical Engineering or related field</b></li><li>0&ndash;2 years of experience or fresher with strong interest in Regulatory Affairs</li><li>Basic understanding of <b>regulatory requirements for medical devices </b></li><li>Good documentation and organizational skills</li><li>Proficient in MS Word, Excel, and email communication</li><li>Ability to work under guidance and meet deadlines</li></ul><p>Job Type: Full-time</p><p>Pay: &#8377;12,000.00 - &#8377;15,000.00 per month</p><p>Application Question(s):</p><ul><li>Current salary</li><li>Expected salary </li></ul><p>Work Location: In person</p>

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