regulatory affairs coordinator

Virginia Commonwealth University

<div><div><div><div><div><ul><li>45001868
</li></ul></div><div><ul><li>907 Floyd Avenue, MCV Main Campus, Virginia, United States, 23284
</li></ul></div><div><ul><li>Research
</li></ul></div><div><ul><li>Staff
</li></ul></div><div><ul><li>School Of Medicine MBU</li></ul></div></div><div> 
</div><div>Advertising Summary: Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU&rsquo;s sponsored research, the School of Medicine is internationally recognized for patient care and education. Virginia Commonwealth University is an equal opportunity employer.

Unit: School Of Medicine MBU

Department: Pauley Heart Center

Department Summary:

Founded more than 20 years ago, the Pauley Heart Center is today the top-ranked heart center in Virginia, and one of only a handful of named heart centers in the nation. Headquartered at VCU Health in Richmond with outpatient centers throughout central and southeast Virginia, Pauley provides clinical services and community education and outreach programs throughout the region.

Cardiovascular disease (CVD) is the leading cause of death nationwide and in Virginia, and despite advances in prevention and treatment in recent decades, CVD disproportionately affects individuals with poor social determinants of health. Pauley's mission is to improve cardiovascular care and reduce health disparities for all through interdisciplinary, cutting-edge, clinical, translational and community-based research; training and developing the next generation of cardiovascular clinicians and researchers across all levels of education; and providing innovative and accessible cardiovascular procedural care (both surgical and catheter-based) that is the best in the Commonwealth. Pauley is a regional and national leader in research, education, and clinical programs involving electrophysiology; advanced cardiac imaging (MRI, CT, echo); advanced heart failure, including device-based treatments, total artificial heart, and heart transplant programs; cardio-oncology; high-risk percutaneous coronary interventions; adult congenital heart disease; and exercise-based cardiovascular disease prevention. Pauley also operates top-flight sub-specialty clinics and research programs investigating cardiac amyloidosis; cardiac sarcoidosis; and hypertrophic cardiomyopathy.

Position Summary: To serve in the key role of Regulatory Affairs Coordinator which will facilitate the successful launch and oversight of clinical research studies at Pauley Heart Center/Division of Cardiology Virginia Commonwealth University. This position supports pre-award, regulatory, and start-up activities to ensure that all institutional, sponsor, and federal requirements are met efficiently and accurately. Working in close collaboration with investigators, research teams, and administrative offices, the coordinator facilitates study activation from proposal development through study initiation, helping to reduce start-up timelines and maintain regulatory compliance. This role is ideal for a detail-oriented professional who thrives in a collaborative environment and is motivated to streamline research processes that advance the Pauley Heart Center mission.

This is a restricted position with no set end date continued employment is dependent upon project need, availability of funding, and performance.

Core Responsibilities:

Research Regulatory and Compliance Coordination (60%)
<ul>
<li>Complete and/or support Pauley Heart Center and Cardiology Divisional research staff with the development and submission of documents to applicable regulatory agencies from study start up through completion (local and central IRBs, varying local committees, FDA, etc.)</li>
<li>Research and provide best applicable regulatory pathways for investigator initiated trials, including drug and device studies</li>
<li>Ensure compliance with FDA, NIH, and institutional regulations related to human subjects protection, Good Clinical Practice (GCP), and data security</li>
<li>Provide support for and/or develop essential trial documents as needed for research projects and trials (protocols, ICFs, scripts, DCFs, data management plans, etc.).</li>
<li>Track renewals, amendments, and continuing reviews to ensure ongoing compliance and study continuity</li>
<li>Assesses and reports problems with study protocol and/or consent form compliance and intervenes appropriately</li>
<li>Other duties as assigned related to research regulatory and compliance</li>
</ul>
Pre-award Coordination (40%)
<ul>
<li>Assist faculty and study teams with preparation, review, and submission of grant and contract proposals including review of funding announcements</li>
<li>Ensure pre-award materials meet all VCU, sponsor, and federal guidelines</li>
<li>Coordinate internal routing and approval processes (RAMS-SPOT, Proposal Central, etc.) and ensure timely submission of proposals</li>
<li>Coordinate with research finance and contracting offices to ensure budgets and scopes of work reflect regulatory and compliance requirements</li>
<li>Track pre-award timelines and communicate updates to principal investigators and departmental/center leadership</li>
<li>Collaborate with Division of Sponsored Programs (DSP) and departmental research administrators on budget revisions, just-in-time submissions, and funding notifications</li>
<li>Other duties as assigned related to pre-award support</li>
</ul>
Qualifications:

Minimum Hiring Standards:
<ul><li>Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.</li>
<li>Knowledge of research development, execution, and administration.</li>
<li>Excellent written, oral and interpersonal communication skills. Meticulous attention to detail for comprehension of nuanced regulations.</li>
<li>Ability to manage multiple projects, multi-task and prioritize autonomously. Able to work in a fast paced, demanding environment and adapt to changing client status, regulations and work environment.</li>
<li>Demonstrated knowledge of medical terminology. Demonstrated proficiency with multiple computer applications, including but not limited to: MS Word, MS Excel, spreadsheet management, PDF file creation/use, online database use.</li>
<li>Requires analytical skills to resolve problems that require the use of basic scientific, mathematical or technical principles.</li>
</ul>
Required Education and Experience:
<ul>
<li>Bachelor&rsquo;s degree or relevant experience in a healthcare or academic research setting</li>
<li>Must maintain appropriate certifications and trainings (e.g., CITI Human Subjects, GCP)</li>
<li>Ability to work in a fast-paced, demanding, and diverse environment and adapt to changing client status, regulations, and work environment</li>
<li>Demonstrated knowledge of medical terminology</li>
<li>Excellent discretionary decision-making and problem-solving skills</li>
<li>Independent, self-motivated, and organized</li>
<li>Excellent written, verbal, and interpersonal skills</li>
</ul>
Preferred Qualifications
<ul>
<li>2+ years of experience in regulatory affairs for clinical research (especially in cardiovascular, translational, or academic medical center context)</li>
<li>Experience with human subject research participants</li>
<li>Experience with regulatory submissions/compliance to both local and central IRB&rsquo;s</li>
</ul>
Salary Range: $55,000 - $70,000

Benefits: All full-time university staff are eligible for VCU&rsquo;s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt 
 
Hours per Week: 40

Restricted Position: Yes

ORP Eligible: No

Flexible Work Arrangement: Hybrid

University Job Title: 3411B - Clinical Research Coordinator Base

Contact Information: 
Contact Name: Cheyenne Taylor 
Contact Email: Cheyenne.Taylor@vcuhealth.org</div></div></div></div>

Clinical Research Regulatory Coordinator, School of Medicine/Internal Medicine/Cardiology

<div><div><div><ul><li>45001868
</li></ul></div><div><ul><li>907 Floyd Avenue, MCV Main Campus, Virginia, United States, 23284
</li></ul></div><div><ul><li>SVP Health Sciences SML
</li></ul></div><div><ul><li>Research
</li></ul></div><div><ul><li>Staff
</li></ul></div><div><ul><li>Virginia Commonwealth University</li></ul></div></div><div> 
</div><div>Advertising Summary: Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU&rsquo;s sponsored research, the School of Medicine is internationally recognized for patient care and education. Virginia Commonwealth University is an equal opportunity employer.

Unit: School Of Medicine MBU

Department: Pauley Heart Center

Department Summary:

Founded more than 20 years ago, the Pauley Heart Center is today the top-ranked heart center in Virginia, and one of only a handful of named heart centers in the nation. Headquartered at VCU Health in Richmond with outpatient centers throughout central and southeast Virginia, Pauley provides clinical services and community education and outreach programs throughout the region.

Cardiovascular disease (CVD) is the leading cause of death nationwide and in Virginia, and despite advances in prevention and treatment in recent decades, CVD disproportionately affects individuals with poor social determinants of health. Pauley's mission is to improve cardiovascular care and reduce health disparities for all through interdisciplinary, cutting-edge, clinical, translational and community-based research; training and developing the next generation of cardiovascular clinicians and researchers across all levels of education; and providing innovative and accessible cardiovascular procedural care (both surgical and catheter-based) that is the best in the Commonwealth. Pauley is a regional and national leader in research, education, and clinical programs involving electrophysiology; advanced cardiac imaging (MRI, CT, echo); advanced heart failure, including device-based treatments, total artificial heart, and heart transplant programs; cardio-oncology; high-risk percutaneous coronary interventions; adult congenital heart disease; and exercise-based cardiovascular disease prevention. Pauley also operates top-flight sub-specialty clinics and research programs investigating cardiac amyloidosis; cardiac sarcoidosis; and hypertrophic cardiomyopathy.

Position Summary: To serve in the key role of Regulatory Affairs Coordinator which will facilitate the successful launch and oversight of clinical research studies at Pauley Heart Center/Division of Cardiology Virginia Commonwealth University. This position supports pre-award, regulatory, and start-up activities to ensure that all institutional, sponsor, and federal requirements are met efficiently and accurately. Working in close collaboration with investigators, research teams, and administrative offices, the coordinator facilitates study activation from proposal development through study initiation, helping to reduce start-up timelines and maintain regulatory compliance. This role is ideal for a detail-oriented professional who thrives in a collaborative environment and is motivated to streamline research processes that advance the Pauley Heart Center mission.

This is a restricted position with no set end date continued employment is dependent upon project need, availability of funding, and performance.

Core Responsibilities:

Research Regulatory and Compliance Coordination (60%)
<ul>
<li>Complete and/or support Pauley Heart Center and Cardiology Divisional research staff with the development and submission of documents to applicable regulatory agencies from study start up through completion (local and central IRBs, varying local committees, FDA, etc.)</li>
<li>Research and provide best applicable regulatory pathways for investigator initiated trials, including drug and device studies</li>
<li>Ensure compliance with FDA, NIH, and institutional regulations related to human subjects protection, Good Clinical Practice (GCP), and data security</li>
<li>Provide support for and/or develop essential trial documents as needed for research projects and trials (protocols, ICFs, scripts, DCFs, data management plans, etc.).</li>
<li>Track renewals, amendments, and continuing reviews to ensure ongoing compliance and study continuity</li>
<li>Assesses and reports problems with study protocol and/or consent form compliance and intervenes appropriately</li>
<li>Other duties as assigned related to research regulatory and compliance</li>
</ul>
Pre-award Coordination (40%)
<ul>
<li>Assist faculty and study teams with preparation, review, and submission of grant and contract proposals including review of funding announcements</li>
<li>Ensure pre-award materials meet all VCU, sponsor, and federal guidelines</li>
<li>Coordinate internal routing and approval processes (RAMS-SPOT, Proposal Central, etc.) and ensure timely submission of proposals</li>
<li>Coordinate with research finance and contracting offices to ensure budgets and scopes of work reflect regulatory and compliance requirements</li>
<li>Track pre-award timelines and communicate updates to principal investigators and departmental/center leadership</li>
<li>Collaborate with Division of Sponsored Programs (DSP) and departmental research administrators on budget revisions, just-in-time submissions, and funding notifications</li>
<li>Other duties as assigned related to pre-award support</li>
</ul>
Qualifications:

Minimum Hiring Standards:
<ul><li>Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.</li>
<li>Knowledge of research development, execution, and administration.</li>
<li>Excellent written, oral and interpersonal communication skills. Meticulous attention to detail for comprehension of nuanced regulations.</li>
<li>Ability to manage multiple projects, multi-task and prioritize autonomously. Able to work in a fast paced, demanding environment and adapt to changing client status, regulations and work environment.</li>
<li>Demonstrated knowledge of medical terminology. Demonstrated proficiency with multiple computer applications, including but not limited to: MS Word, MS Excel, spreadsheet management, PDF file creation/use, online database use.</li>
<li>Requires analytical skills to resolve problems that require the use of basic scientific, mathematical or technical principles.</li>
</ul>
Required Education and Experience:
<ul>
<li>Bachelor&rsquo;s degree or relevant experience in a healthcare or academic research setting</li>
<li>Must maintain appropriate certifications and trainings (e.g., CITI Human Subjects, GCP)</li>
<li>Ability to work in a fast-paced, demanding, and diverse environment and adapt to changing client status, regulations, and work environment</li>
<li>Demonstrated knowledge of medical terminology</li>
<li>Excellent discretionary decision-making and problem-solving skills</li>
<li>Independent, self-motivated, and organized</li>
<li>Excellent written, verbal, and interpersonal skills</li>
</ul>
Preferred Qualifications
<ul>
<li>2+ years of experience in regulatory affairs for clinical research (especially in cardiovascular, translational, or academic medical center context)</li>
<li>Experience with human subject research participants</li>
<li>Experience with regulatory submissions/compliance to both local and central IRB&rsquo;s</li>
</ul>
Salary Range: $55,000 - $70,000

Benefits: All full-time university staff are eligible for VCU&rsquo;s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt 
 
Hours per Week: 40

Restricted Position: Yes

ORP Eligible: No

Flexible Work Arrangement: Hybrid

University Job Title: 3411B - Clinical Research Coordinator Base

Contact Information: 
Contact Name: Cheyenne Taylor 
Contact Email: Cheyenne.Taylor@vcuhealth.org</div></div>

Stellar Hunters

<div><h4 class="jobSectionHeader">Job Summary</h4>
We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to ensure that products, processes, and operations comply with applicable regulatory requirements. The successful candidate will support product registrations, maintain regulatory documentation, and liaise with regulatory authorities to ensure timely approvals and ongoing compliance.
This role requires strong understanding of regulatory frameworks, documentation accuracy، and the ability to work cross-functionally in a fast-paced, compliance-driven environment.<h4 class="jobSectionHeader">
Key Responsibilities</h4><h5 class="jobSectionHeader">
Regulatory Submissions &amp; Approvals</h5><ul><li>
Prepare, review, and submit regulatory dossiers and documentation to relevant authorities (e.g., SFDA or other applicable bodies).</li><li>
Track and manage product registration timelines, renewals, and approvals.</li></ul><h5 class="jobSectionHeader">
Compliance &amp; Documentation</h5><ul><li>
Ensure all products and processes comply with local and international regulatory requirements.</li><li>
Maintain up-to-date regulatory documentation, technical files, and records.</li></ul><h5 class="jobSectionHeader">
Regulatory Intelligence</h5><ul><li>
Monitor changes in regulations and guidelines and assess their impact on the business.</li><li>
Communicate regulatory updates to internal stakeholders and recommend necessary actions.</li></ul><h5 class="jobSectionHeader">
Cross-functional Collaboration</h5><ul><li>
Work closely with R&amp;D, Quality, Manufacturing, and Marketing teams to ensure compliance throughout the product lifecycle.</li><li>
Support new product development by providing regulatory guidance and requirements.</li></ul><h5 class="jobSectionHeader">
Audit &amp; Inspection Support</h5><ul><li>
Support internal and external audits, inspections, and regulatory inquiries.</li><li>
Ensure readiness and proper documentation for compliance reviews.</li></ul><h5 class="jobSectionHeader">
Labeling &amp; Claims Review</h5><ul><li>
Review product labeling, packaging, and marketing materials to ensure regulatory compliance.</li><li>
Ensure all product claims are supported and aligned with regulatory standards.</li></ul><h5 class="jobSectionHeader">
Continuous Improvement</h5><ul><li>
Identify opportunities to improve regulatory processes, documentation systems, and submission workflows.</li></ul><h4 class="jobSectionHeader">
Required Qualifications - Skills &amp; Experience</h4><ul><li>
Bachelor&rsquo;s degree in Pharmacy, Life Sciences, Chemistry, or a related field.</li><li>
2&ndash;5 years of experience in regulatory affairs, preferably within pharmaceutical, medical device, or FMCG industries.</li><li>
Strong knowledge of regulatory frameworks and submission processes.</li><li>
Experience with product registration and regulatory documentation.</li><li>
Excellent attention to detail and organizational skills.</li><li>
Strong communication and stakeholder management skills.</li></ul><h4 class="jobSectionHeader">
Preferred Qualifications</h4><ul><li>
Experience with Saudi regulatory bodies such as SFDA.</li><li>
Familiarity with GCC or international regulatory requirements.</li><li>
Experience with electronic submission systems and regulatory databases.</li><li>
Certification or training in regulatory affairs is a plus.</li></ul><h4 class="jobSectionHeader">
Work Environment &amp; Compensation</h4><ul><li>
Full-time position with an onsite model.</li><li>
Competitive salary commensurate with experience and a comprehensive benefits package, including health insurance, retirement plan options, and paid time off.</li><li>
Opportunities for professional development, training, and certification support; clear paths for career growth within IT and cross-functional teams.</li><li>
Inclusive culture that values diversity, equity, work-life balance, and employee well-being.</li></ul></div>

Regulatory Affairs Specialist

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Cincinnati, Ohio, United States of America
Job Description:
About Surgery
Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that&rsquo;s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world&rsquo;s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.
We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our active capital, energy-based business. This role will work a Flex/Hybrid schedule and be based in the Cincinnati, OH office. There is NO remote option and relocation assistance is not provided.
Purpose: The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for MedTech Surgery. The individual combines knowledge of scientific, regulatory and business issues to ensure that products meet the required legislation the United States and global health authorities. Through your engagement in this role, you will help shape the surgical field.
You will be responsible for:<ul><li>
Prepare and submit regulatory documents, including applications for new product registrations and maintenance of existing registrations, to US FDA and EU Notified Bodies).</li><li>
Collaborate with global regulatory partners to drive innovation and prepare global regulatory submissions.</li><li>
Maintain device registrations and licenses throughout product lifecycle. Support product lifecycle. Evaluate proposed device changes for regulatory requirements and perform required regulatory submissions. Assist in the development of multi-country regulatory strategy.</li><li>
Monitor changes in regulations. Maintain and update strategy based upon regulatory changes in responsible jurisdictions.</li><li>
Provide regulatory support with teammates for internal and external audits (e.g. MDSAP).</li></ul>
Be passionate about Regulatory Affairs impact in research, development, clinical, marketing, and production of state-of-the-art medical devices.<ul><li>
Able to manage multiple overlapping priorities across projects.</li></ul>
Qualifications / Requirements:<ul><li>
Minimum of a Bachelor&rsquo;s Degree required. Science or Engineering discipline highly desired.</li><li>
At least 4+ years of related professional Regulatory Affairs experience required (2+ with Advanced Degree).</li><li>
Ability to comprehend principles of engineering, physiology and medical device use.</li><li>
Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.</li><li>
Exceptional self-education skills required, including proactive and comprehensive research of new and existing regulations, processes, and tools before requesting assistance.</li><li>
Strong verbal communication and regulatory/medical writing skills.</li><li>
Ability to effectively manage multiple projects and priorities.</li><li>
Exhibit leadership traits such as a positive, forward looking appraoch to problem-solving, and accountable, action-oriented, appraoch to deliver results. Results oriented and ability to meet project schedules.</li><li>
Enjoy teamwork and thrive as a member of cross-functional teams.</li><li>
Be adaptable and thrive in a dynamic work environment where variety is the routine.</li><li>
Experience with US Class II device submissions .</li><li>
Experience with active medical devices, including software, cybersecurity and electromagnetic evaluation submissions, preferred.</li><li>
Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) is a plus.</li><li>
Travel up to 10%.</li></ul>
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
The anticipated base pay range for this position is :
$92,000.00 - $148,350.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company&rsquo;s consolidated retirement plan (pension) and savings plan (401(k)). 
 
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 
 
Vacation &ndash;120 hours per calendar year 
 
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado &ndash;48 hours per calendar year; for employees who reside in the State of Washington &ndash;56 hours per calendar year 
 
Holiday pay, including Floating Holidays &ndash;13 days per calendar year 
 
Work, Personal and Family Time - up to 40 hours per calendar year 
 
Parental Leave &ndash; 480 hours within one year of the birth/adoption/foster care of a child 
 
Bereavement Leave &ndash; 240 hours for an immediate family member: 40 hours for an extended family member per calendar year 
 
Caregiver Leave &ndash; 80 hours in a 52-week rolling period10 days 
 
Volunteer Leave &ndash; 32 hours per calendar year 
 
Military Spouse Time-Off &ndash; 80 hours per calendar year 
 
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid</div>

Senior Regulatory Affairs Specialist - MedTech Surgery

Arcera Life Sciences

<div>
 
 Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.
 
 
 
 
 
 This position is based in
 
 Cairo, Egypt
 
 and will report directly to the
 
 Regulatory Affairs Lead, GULF.
 
 The role will be responsible to support the RA Lead on all regulatory activities of assigned products within the Gulf region (UAE, Bahrain, Kuwait, Oman and Qatar). Ensure all Regulatory activities are conducted in compliance with local regulations and company policies and SOPs as well as support the Business through strong cross-functional collaboration.
 
 
 
 
 
 
 Your Responsibilities will be:
 
 
 
 
 
 <ul>
 <li>
 Support the Regulatory Affairs Lead on all the assigned Regulatory activities within the Gulf.
 </li>
 <li>
 Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.
 </li>
 <li>
 Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region (variations, product renewals, site registration renewals, new registrations etc.).
 </li>
 <li>
 Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
 </li>
 <li>
 Responsible of ordering and legalization of local CPP and other module 1 documents for local products.
 </li>
 <li>
 Perform regulatory due diligence on module 1 for all assigned products for the Gulf according to internal process/guidance according to EU/local Region regulatory requirements.
 </li>
 <li>
 Ensure that the regulatory file is complete and available for dispatch to the distributor and timely submitted to the local Health Authorities.
 </li>
 <li>
 Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.
 </li>
 <li>
 Co-ordinate the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.
 </li>
 <li>
 Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the assigned region.
 </li>
 <li>
 Maintain the Regulatory databases: drug track and docubridge for local products.
 </li>
 <li>
 Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
 </li>
 <li>
 Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
 </li>
 <li>
 All trainings to be completed as per training plan.
 </li>
 </ul>
 
 
 
 
 
 Your Profile:
 
 
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmacy or a relevant field.
 </li>
 <li>
 0 &ndash; 3 years of experience working in the Pharmaceutical industry in Regulatory Affairs and extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.
 </li>
 <li>
 Fluent level in English and Arabic both in oral and written communication.
 </li>
 </ul>
 
 
 
 
 This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!
 
</div>

Regulatory Affairs Associate, GULF

Masjid-e-Aqsa Admin

Job Title: Religious Affairs Coordinator Organization: Masjid-e-Aqsa Admin Location: Doha, Qatar Al Rayyan District Salary: QAR 11,000 per monthJob Description:Masjid-e-Aqsa Admin is seeking a dedicated and organized Religious Affairs Coordinator to support the management of religious programs, community activities, and administrative functions within the mosque. The ideal candidate will ensure smooth coordination of religious services and help maintain a respectful and well-organized environment for worshippers.Key Responsibilities:<ul><li>Coordinate daily, weekly, and special religious programs and activities</li><li>Support the organization of prayers, sermons, and religious events</li><li>Liaise with religious scholars, speakers, and community members</li><li>Manage schedules for imams, guest speakers, and event activities</li><li>Assist in planning educational and community outreach programs</li><li>Maintain records of religious activities and attendance</li><li>Ensure proper arrangement and preparation of facilities for events</li><li>Address community inquiries with respect and professionalism</li><li>Coordinate with mosque administration for operational needs</li><li>Promote a peaceful and organized environment within the mosque</li></ul>Qualifications and Experience:<ul><li>Bachelor&rsquo;s degree in Islamic Studies, Religious Studies, Education, or a related field preferred</li><li>Minimum of 2&ndash;4 years of experience in religious, community, or administrative coordination roles</li><li>Strong understanding of Islamic values and practices</li><li>Excellent organizational and communication skills</li><li>Ability to work respectfully with diverse community members</li><li>Strong interpersonal and coordination abilities</li><li>Basic computer skills for record-keeping and scheduling</li><li>High level of integrity, patience, and professionalism</li><li>Experience in mosque or community organization work is an advantage</li></ul>الراتب المدفوع: QAR١١٬٠٠٠٫٠٠&nbsp;لكل شهرموقع العمل: بشكل شخصي

Religious Affairs Coordinator

K-Electric

<div>
 
 
 Purpose
 
 :
 
 
 To facilitate Regulatory Affairs team in day-to-day operations.
 
 
 
 
 
 
 Areas Of Responsibility:
 
 
 
 &bull; Assist in preparation of regulatory submissions and correspondence related to NEPRA based on detailed assessment of regulatory changes and its possible implications for KE.
 
 
 &bull; Provide support in addressing queries / drafting responses regarding on-going regulatory proceedings.
 
 
 &bull; Provide support to the line manager in ensuring regulatory compliance in consultation with internal stakeholders.&bull; Ensure timely and correct submission of Generation Concurrence cases to NEPRA after thorough scrutiny of received cases from Net Metering team
 
 
 &bull; Provide support to line manager / HoD on ad hoc assignments
 
 
 
 
 
 
 Required Education:
 
 
 
 &bull; Bachelors in relevant field
 
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