regulatory affairs strategy specialist

Jamjoom Pharma

<div><p><b>Role Overview</b></p><p>
We are seeking a detail-oriented and proactive <b>Export Regulatory Affairs Specialist</b> to support global regulatory compliance and international market access. This role is critical in managing export regulatory submissions, ensuring adherence to country-specific requirements, and coordinating cross-functionally to facilitate timely and compliant product exports.</p><p></p><p><b><br>
Key Responsibilities</b></p><ul><li>
Compile, format, and submit dossiers in CTD/eCTD format, ensuring accuracy, consistency, and compliance with international standards.</li><li>
Manage Certificates of Pharmaceutical Product (CPP) issuance and legalization processes.</li><li>
Ensure compliance with export regulations, customs requirements, and country-specific guidelines.</li><li>
Liaise with agents, distributors, and internal teams to resolve regulatory queries.</li><li>
Maintain up-to-date knowledge of global regulatory frameworks and changes impacting exports.</li><li>
Support audits, inspections from export countries.</li><li>
Develop and optimize workflows for regulatory submissions and export documentation.</li></ul><p></p><p><b><br>
Qualifications &amp; Requirements</b></p><p><b>
Education</b></p><ul><li>Bachelor&rsquo;s degree in <b>pharmacy, Life Sciences</b>, or a related field (mandatory).</li><li>Additional training or certification in Regulatory Affairs is considered a plus.</li></ul><p></p><p><b><br>
Experience</b></p><ul><li><b>3&ndash;5 years</b> of hands-on experience in Regulatory Affairs within the pharmaceutical industry, with a strong focus on <b>export submissions</b>.</li><li>Proven experience in <b>CTD/eCTD dossier preparation, publishing, and submission</b> for international markets.</li><li>Solid knowledge of international regulatory requirements and export-related guidelines.</li><li>Experience working with agents and distributors across multiple countries is an advantage.</li></ul><p></p><p><b><br>
Skills &amp; Competencies</b></p><ul><li><b>Regulatory Expertise:</b> Strong understanding of global regulatory frameworks and export compliance requirements.</li><li><b>Technical Writing:</b> Excellent ability to prepare clear, accurate, and compliant regulatory documentation.</li><li><b>Communication:</b> Fluent in <b>English</b> (written and spoken); <b>French language skills are required</b>.</li><li><b>Organization &amp; Attention to Detail:</b> High level of accuracy in managing multiple dossiers and regulatory documents.</li><li><b>Cross-functional Collaboration:</b> Ability to work effectively with internal teams and external partners.</li><li><b>Systems &amp; Tools:</b> Proficient in documentation management systems and <b>MS Office</b> applications.</li><li><b>Problem Solving:</b> Proactive in identifying issues and driving timely regulatory solutions.</li><li><b>Integrity &amp; Compliance:</b> Demonstrates strong ethical standards and commitment to regulatory compliance.</li></ul></div>

Export Regulatory Affairs Specialist

Amazon.com

<div><h2 class="jobSectionHeader"><b>DESCRIPTION</b></h2><p>
How do you get items to customers quickly, cost-effectively, and&mdash;most importantly&mdash;safely, in less than an hour? And how do you do it in a way that can scale? Our teams of hundreds of scientists, engineers, aerospace professionals, and futurists have been working hard to do just that! We are delivering to customers and are excited for what&rsquo;s to come. If you are seeking an iterative environment where you can drive innovation, apply state-of-the-art technologies to solve real world delivery challenges, and provide benefits to customers, Prime Air is the place for you. Come work on the Amazon Prime Air Team! Check out more information about Prime Air on the About Amazon blog: https://www.aboutamazon.com/news/tag/drone<br>
<br>
The Opportunity<br>
As Amazon Prime Air expands its drone delivery service, we're seeking a Senior Regulatory Affairs Specialist to join our U.S. Regulatory Affairs Infrastructure and Strategy team. This is a pivotal role where you'll shape the regulatory landscape for commercial drone delivery, working at the intersection of technology and aviation policy. You'll be instrumental in obtaining setting and achieving regulatory goals, engaging with regulators and other decision makers, and helping to establish the framework that will further enable safe, scalable drone delivery operations across the United States.<br>
<br>
In this position you will serve as a bridge between Amazon's innovative technology teams and regulatory bodies, engaging with internal experts to determine and update Prime Air&rsquo;s regulatory goals and translating those objectives into regulatory strategies while navigating the evolving landscape of unmanned aircraft systems regulations. This position will also ensure that internal partners are aware of regulatory developments and requirements. Your work will directly impact our ability to continue to expand Prime Air's operations and bring this transformative service to more customers.<br>
<br>
Export Control License: This position may require a deemed export control authorization for compliance with applicable laws and regulations. Placement is contingent on Amazon&rsquo;s ability to apply for and obtain an export control license on your behalf.<br>
<br>
Key job responsibilities<br>
Drive Regulatory Strategy: Set regulatory objectives and secure internal buy-in and support.
<br>
<br>
Serve as Regulatory Expert: Act as the subject matter expert supporting internal teams, translating technical objectives to regulatory bodies and keeping stakeholders informed of regulatory developments<br>
<br>
Lead Cross-Functional Collaboration: Partner with Legal, Public Policy, Public Relations, Engineering, and Operations teams to manage projects effectively and align on goals, approaches, and messaging<br>
<br>
Represent Prime Air: Coordinate or directly represent Prime Air in standards development organizations and other fora</p><h2 class="jobSectionHeader"><b>
BASIC QUALIFICATIONS</b></h2><ul><li>Experience with regulatory filings and reports or equivalent</li><li>Experience with communication, presentation, and negotiation</li><li>Experience handling ambiguous or undefined challenges through strong problem solving abilities</li><li>Bachelor's degree</li><li>6+ years of experience working with aviation regulations, regulatory permissions, and/or aviation stakeholder outreach</li><li>Strong familiarity with FAA regulations and policies</li><li>Experience with aviation rulemaking and standards-setting processes</li><li>Background representing organization interests in standards development organizations or similar groups</li></ul><h2 class="jobSectionHeader"><b>
PREFERRED QUALIFICATIONS</b></h2><ul><li>Experience working with multiple groups of stakeholders</li><li>Master's degree</li><li>Experience working with aviation regulations, regulatory permissions, and/or aviation stakeholders, ideally in the drone field, with proven ability to lead projects and people in a fast-paced environment</li><li>Previous work with drone regulatory areas such as Unmanned Traffic Management (UTM), spectrum management, hazardous materials (HazMat), security, and/or drone spectrum and communications topics</li></ul><br>
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.<br>
<br>
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you&rsquo;re applying in isn&rsquo;t listed, please contact your Recruiting Partner.<br>
<br>
Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $133,800/year in our lowest geographic market up to $231,300/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit https://www.aboutamazon.com/workplace/employee-benefits. This position will remain posted until filled. Applicants should apply via our internal or external career site.</div>

Sr. Regulatory Affairs Specialist, Amazon Prime Air

IQVIA

<div><div><div>New Cairo, Egypt | Full time | Hybrid | R1521166</div></div><p></p><div><div><br>
We are hiring for a Senior Regulatory Role and are looking for an individual contributor who is proficient in regulatory knowledge and can work with a high sense of ownership under limited supervision. The role covers Egypt (experience in imported pharmaceutical and biological products), Libya, the GCC, and Jordan.</div><div>
This role reports to the Regulatory Affairs Manager and is based in Egypt.</div><div><b>
Scope of Work</b></div><ul><li><div>
Egypt, Libya, Jordan, and GCC regulatory experience is required.</div></li><li><div>
Act as a Regional Regulatory Affairs Strategist on complex regulatory projects, developing and implementing country-level strategies in Egypt, Libya, Jordan, and the GCC.</div></li><li><div>
Experience in both pharmaceuticals and biologicals is mandatory; medical device experience is a plus.</div></li><li><div>
Experience with reliance regulations in Egypt and the GCC is essential.</div></li></ul><div><b>
Responsibilities</b></div><ul><li><div>
Prepare, review, and submit regulatory documentation (e.g., CTD and eCTD submissions); ensure follow-through on post-approval commitments.</div></li><li><div>
Maintain product licenses in designated countries by overseeing all regulatory activities, including site registration and renewal, tender support, variations (CMC, labeling, MAT, administrative), product renewals, and withdrawals.</div></li><li><div>
Review promotional materials for compliance with Health Authority (HA) requirements and ensure relevant HA approvals are obtained.</div></li><li><div>
Possess good knowledge of pharmacovigilance requirements in relevant countries.</div></li><li><div>
Engage with health authority officials as needed and represent the client.</div></li><li><div>
Establish strong relationships with stakeholders, present regulatory projects and progress, and discuss issues and customer feedback.</div></li><li><div>
Act as a subject matter expert in regulatory knowledge implementation for lifecycle maintenance, marketing authorization transfers, labeling, publishing, change assessments, and other relevant areas.</div></li><li><div>
Stay updated with regulatory intelligence information from different health authorities, communicate insights to clients and working groups, and define the best strategies while anticipating future trends.</div></li><li><div>
Understand the scope of work, deliverables, and management of budgets for several projects; manage workload appropriately.</div></li><li><div>
Provide guidance to junior colleagues, including feedback on technical documents and assistance with their training, development, onboarding, and internships.</div></li><li><div>
Perform other tasks or assignments as delegated by Regulatory Management.</div></li></ul><div><b>
Qualifications</b></div><ul><li><div>
Degree in life sciences or a related discipline is required; a professional postgraduate degree is a plus.</div></li><li><div>
High proficiency in English and Arabic is essential; French proficiency is a plus.</div></li><li><div>
At least 3-5 years of relevant regulatory experience in a national or regional scope of work.</div></li><li><div>
Good understanding of regulations and related guidelines in the Gulf, Egypt, and Jordan.</div></li><li><div>
Good understanding of pharmaceutical and biological regulations; medical device knowledge is a plus.</div></li><li><div>
Familiarity with different regulatory dossiers (CTD, eCTD, NeeS) is a must.</div></li><li><div>
Ability to read and understand high-level SOPs and e-trainings and to learn quickly within tight onboarding timelines.</div></li><li><div>
Tech-savvy with proficiency in Veeva, digital workspace tools, publishing applications, Power BI, Task Planner, SharePoint, and other Microsoft Office tools; ability to collaborate effectively.</div></li><li><div>
Knowledge of pharmaceutical industry operations.</div></li><li><div>
Strong interpersonal communication and organizational skills.</div></li><li><div>
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</div></li><li><div>
Demonstrates self-motivation, enthusiasm, and a high sense of ownership.</div></li><li><div>
Organized with meticulous attention to detail to ensure accuracy in documentation and compliance.</div></li></ul><div>
If you believe you can bring adaptability to a rapidly changing environment, a problem-solving attitude, and a readiness to continuously upgrade your skills, please apply.</div><div>
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</div></div></div><div></div>

Senior Regulatory Affairs Specialist - Egypt

<p></p><div><p>We are hiring for a Senior Regulatory Role and are looking for an individual contributor who is proficient in regulatory knowledge and can work with a high sense of ownership under limited supervision. The role covers Egypt (experience in imported pharmaceutical and biological products), Libya, the GCC, and Jordan.</p><p></p><p>
This role reports to the Regulatory Affairs Manager and is based in Egypt.</p><p><b>
Scope of Work</b></p><ul><li><p>
Egypt, Libya, Jordan, and GCC regulatory experience is required.</p></li><li><p>
Act as a Regional Regulatory Affairs Strategist on complex regulatory projects, developing and implementing country-level strategies in Egypt, Libya, Jordan, and the GCC.</p></li><li><p>
Experience in both pharmaceuticals and biologicals is mandatory; medical device experience is a plus.</p></li><li><p>
Experience with reliance regulations in Egypt and the GCC is essential.</p></li></ul><p></p><p><b>
Responsibilities</b></p><ul><li><p>
Prepare, review, and submit regulatory documentation (e.g., CTD and eCTD submissions); ensure follow-through on post-approval commitments.</p></li><li><p>
Maintain product licenses in designated countries by overseeing all regulatory activities, including site registration and renewal, tender support, variations (CMC, labeling, MAT, administrative), product renewals, and withdrawals.</p></li><li><p>
Review promotional materials for compliance with Health Authority (HA) requirements and ensure relevant HA approvals are obtained.</p></li><li><p>
Possess good knowledge of pharmacovigilance requirements in relevant countries.</p></li><li><p>
Engage with health authority officials as needed and represent the client.</p></li><li><p>
Establish strong relationships with stakeholders, present regulatory projects and progress, and discuss issues and customer feedback.</p></li><li><p>
Act as a subject matter expert in regulatory knowledge implementation for lifecycle maintenance, marketing authorization transfers, labeling, publishing, change assessments, and other relevant areas.</p></li><li><p>
Stay updated with regulatory intelligence information from different health authorities, communicate insights to clients and working groups, and define the best strategies while anticipating future trends.</p></li><li><p>
Understand the scope of work, deliverables, and management of budgets for several projects; manage workload appropriately.</p></li><li><p>
Provide guidance to junior colleagues, including feedback on technical documents and assistance with their training, development, onboarding, and internships.</p></li><li><p>
Perform other tasks or assignments as delegated by Regulatory Management.</p></li></ul><p></p><p><b>
Qualifications</b></p><ul><li><p>
Degree in life sciences or a related discipline is required; a professional postgraduate degree is a plus.</p></li><li><p>
High proficiency in English and Arabic is essential; French proficiency is a plus.</p></li><li><p>
At least 3-5 years of relevant regulatory experience in a national or regional scope of work.</p></li><li><p>
Good understanding of regulations and related guidelines in the Gulf, Egypt, and Jordan.</p></li><li><p>
Good understanding of pharmaceutical and biological regulations; medical device knowledge is a plus.</p></li><li><p>
Familiarity with different regulatory dossiers (CTD, eCTD, NeeS) is a must.</p></li><li><p>
Ability to read and understand high-level SOPs and e-trainings and to learn quickly within tight onboarding timelines.</p></li><li><p>
Tech-savvy with proficiency in Veeva, digital workspace tools, publishing applications, Power BI, Task Planner, SharePoint, and other Microsoft Office tools; ability to collaborate effectively.</p></li><li><p>
Knowledge of pharmaceutical industry operations.</p></li><li><p>
Strong interpersonal communication and organizational skills.</p></li><li><p>
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</p></li><li><p>
Demonstrates self-motivation, enthusiasm, and a high sense of ownership.</p></li><li><p>
Organized with meticulous attention to detail to ensure accuracy in documentation and compliance.</p></li></ul><p></p><p>
If you believe you can bring adaptability to a rapidly changing environment, a problem-solving attitude, and a readiness to continuously upgrade your skills, please apply.</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>

Snibe

<div>
 <p>
  <strong>
   Key Responsibilities:
  </strong>
 </p>
 <p>
  * DRAP registration of IVD kits and analyzers
 </p>
 <p>
  * Renewal, variation, and post registration submissions
 </p>
 <p>
  * Review of IFU, labels, and artwork
 </p>
 <p>
  * Response to DRAP observations and regulatory correspondence
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Requirements:
  </strong>
 </p>
 <p>
  <strong>
   1.Education (HEC recognized):
  </strong>
 </p>
 <p>
  * Doctor of Pharmacy (Pharm D)
 </p>
 <p>
  * Bachelor of Pharmacy (B Pharm)
 </p>
 <p>
  * MPhil in Medical Sciences, Biochemistry, or Pharmaceutical Sciences
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   2.Professional Registration:
  </strong>
 </p>
 <p>
  * Valid Pharmacy Council registration (mandatory for Pharm D and B Pharm)
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   3.Experience:
  </strong>
 </p>
 <p>
  * Minimum 3 years experience in regulatory affairs
 </p>
 <p>
  * Hands on experience with IVD, immunoassay, and clinical chemistry product portfolios, including diagnostic kits, analyzers, and reagents
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   4.Skills:
  </strong>
 </p>
 <p>
  * Strong knowledge of DRAP IVD regulations
 </p>
 <p>
  * Good written English and documentation skills
 </p>
 <p>
  * Ability to manage multiple registrations independently
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Work location:
  </strong>
 </p>
 <p>
  Islamabad (Close coordination with DRAP HQ)
 </p>
 <p>
 </p>
</div>


Regulatory Affairs Specialist-Pakistan

Mondelēz International

<p></p><div><div><p>Job Description</p><p></p><p><b>
Are You Ready to Make It Happen at Mondelēz International?</b></p><p></p><p><b>
Join our Mission to Lead the Future of Snacking. Make It With Pride.</b></p><p></p><p>
You execute the regulatory affairs strategy for your respective category or categories and geographical area using your technical and regulatory knowledge. You ensure our policies, regulatory programs and requirements of our portfolio carried out.</p><p></p><p><b>
How you will contribute</b></p><p></p><p>
You will deliver on the regulatory affairs strategy and compliance agenda and work with cross-functional stakeholders to assess regulatory business risks and opportunities. You will provide regulatory affairs expertise for technical regulatory developments and help in responses to challenges and crisis management. In this role, you will ensure that ingredients, product composition, claims and labelling compliance are within applicable regulations and company policies. In addition, you will provide guidance to stakeholders on developments in regulatory affairs, support regulatory impact assessments and change management, help develop regulatory affairs tools, and further develop your knowledge of regulatory, science and nutrition risks and opportunities in your market.</p><p></p><p><b>
What you will bring</b></p><p></p><p>
A desire to drive your future and purpose, accelerate your career and the following experience and knowledge:</p><ul><li>
Networking and communication skills</li><li>
Reliability and accuracy and an efficient work style</li><li>
Meeting deadlines</li><li>
Attending to detail</li><li>
Project management</li><li>
Regulatory affairs in an international and multi-functional environment</li></ul><p></p><p><b>
More about this role</b></p><p>
This position will be responsible for executing the regulatory affairs strategy for their respective categories and geographical area using their technical and regulatory knowledge ensuring compliance to our policies, regulatory programs and requirements of our portfolio.</p><p></p><p><b>
What you need to know about this position:</b></p><ul><li>
This position is a regional position that reports to the Regulatory Center and located at Thane, India. The candidate will be responsible for regulatory affairs for AMEA markets (within Regulatory Centre) and perform daily regulatory activities assigned to the internal hub. This position requires ensuring all projects and Regulatory activities assigned to the internal hub are delivered efficiently, in a timely manner, and are fully compliant with applicable regulations.</li><li>
Manage multiple regulatory project activities for the corresponding region and all categories where required</li><li>
Identifies and escalates risks and issues in regular governance meetings and drives resolution as needed</li><li>
Take personal responsibility for personal growth, driving team collaboration, and finding new, improved, and simpler ways to work.</li><li>
Collaborate and drive various processes and functions within RDQ to include Process/Product/Package Development, Research, Quality, Regulatory &amp; scientific affairs.</li></ul><p></p><p><b>
Education / Certifications:</b></p><p>
Bachelor&rsquo;s or equivalent in relevant field (Food Science or Nutrition preferred)</p><p></p><p><b>
Job specific requirements:</b></p><ul><li>
3- 5 years of experience in Regulatory or related field at a global food manufacturer.</li><li>
Strong attention to detail with a passion to advance regulatory compliance technical skills</li><li>
Basic to Intermediate knowledge in SAP-PLM especially in troubleshooting Issues.</li><li>
Basic knowledge to Digital Regulatory tools (Dragonfly Artwork Approval System, DECERNIS, etc.) including simple troubleshooting of system issues.</li><li>
Technology savvy and willing to work with new system testing and transferring knowledge and experience into SOPs, Job Aids and tool sheets.</li><li>
Basic knowledge of the national Food law regulations for countries of responsibility as well as International Standards (e.g. Codex, FSANZ, GCC) is preferred.</li><li>
Good knowledge of Mondelez business, i.e. market environment and Mondelez trade position as well as Mondelez manufacturing processes and portfolio.</li></ul><p></p><p><b>
Travel requirements:</b></p><p>
Very minimum (max once a year)</p><p></p><p><b>
Work schedule:</b></p><p>
Full-Time</p><p></p>
No Relocation support available<p></p><p>
Business Unit Summary</p><p></p><div>
Mondelēz International in the Middle East, North Africa and Pakistan serves the Middle East and Africa markets as well as Australia, New Zealand, the UK and Canada. Headquartered in Dubai, UAE, we have more than 2600 employees working across seven plants and six commercial offices; we make, bake, sell and deliver our products to customers. We are market leaders in key snacking categories with iconic global and local brands including Cadbury Dairy Milk chocolate, Milka, Oreo and belVita biscuits, Barni Cakes,Tang powdered beverage, Chiclets and Trident gum and Halls candy.</div><p></p><p>
Mondelēz International is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation or preference, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.</p><p></p><p>
Job Type</p><p></p>
Regular<p></p>
Scientific Affairs &amp; Regulatory Affairs<p></p>
Product Quality, Safety and Compliance</div></div><p></p>

Regulatory Specialist, SARA

India Health Link Pvt. Ltd.

<div><h3 class="jobSectionHeader"><b>Role Overview</b></h3><div>
India Health Link Private Limited is seeking a Regulatory Affairs &amp; Compliance Executive to support Indian and international regulatory activities for medical devices and healthcare products. The role will focus on CDSCO submissions, export regulatory coordination, early-stage US FDA strategy support, quality system documentation, and regulatory compliance across the product lifecycle.</div><div>
This position is ideal for a hands-on regulatory professional who is comfortable working across teams, managing documentation, and coordinating with external consultants and regulators.</div><div></div><h2 class="jobSectionHeader"><b><br>
Key Responsibilities</b></h2><h3 class="jobSectionHeader"><b>
Indian Regulatory Affairs (CDSCO)</b></h3><div>
Prepare, submit, and track CDSCO applications including Test Licenses, Manufacturing Licenses, and Free Sale Certificates (FSCs) through NSWS and SUGAM portals.</div><div>
Coordinate clinical study, testing, and evaluation requirements associated with regulatory submissions, working with clinical sites, CROs, manufacturing teams, and internal stakeholders.</div><div>
Track application status, respond to regulatory queries, and support timely approvals.</div><h3 class="jobSectionHeader"><b>
International Regulatory Affairs (Export Markets)</b></h3><div>
Support regulatory pathways for international/export markets in coordination with third-party regulatory agencies and consultants.</div><div>
Track country-specific regulatory dependencies, documentation requirements, and submission timelines.</div><div>
Maintain readiness and version control of documentation required for international regulatory submissions and renewals.</div><h3 class="jobSectionHeader"><b>
US FDA Regulatory Support</b></h3><div>
Support development and execution of a phased US FDA market-entry strategy, including identification of 510(k)-exempt product capabilities.</div><div>
Coordinate with CROs and regulatory consultants to assess FDA regulatory pathways, timelines, and scope of work.</div><div>
Assist in preparing for FDA Quality System and factory-readiness expectations as product scope and risk classification expand.</div><h3 class="jobSectionHeader"><b>
Quality System &amp; Compliance</b></h3><div>
Work closely with Quality Assurance teams to maintain ISO-compliant documentation, including Product Master Files (PMF), Quality Manual, regulatory SOPs, and technical documentation.</div><div>
Draft, review, and maintain regulatory reporting, vigilance, and post-market surveillance (PMS) documentation.</div><div>
Support internal and external audits related to regulatory, quality, and compliance requirements.</div><h3 class="jobSectionHeader"><b>
Data Privacy &amp; Other Regulatory Compliance</b></h3><div>
Coordinate implementation of data-privacy and data-compliance initiatives (including DPDPA requirements) in collaboration with internal teams and external vendors.</div><div>
Support compliance with applicable pricing, data protection, and regulatory frameworks (e.g., NPPA, DPDPA, where applicable).</div><h3 class="jobSectionHeader"><b>
Regulatory Strategy &amp; Documentation Management</b></h3><div>
Maintain device capability matrices, product classification mappings, and intended-use documentation across markets.</div><div>
Interpret regulatory requirements (CDSCO, US FDA, ISO, NPPA, DPDPA) and identify documentation gaps and mitigation actions.</div><div>
Act as a regulatory coordination point between manufacturing, QA, clinical partners, consultants, and management.</div><div></div><h2 class="jobSectionHeader"><b><br>
Qualifications &amp; Experience</b></h2><div>
Bachelor&rsquo;s degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or a related discipline.</div><div>
2&ndash;5 years of experience in regulatory affairs, quality, or compliance within the medical device / healthcare / life sciences sector.</div><div>
Hands-on experience with CDSCO submissions and familiarity with NSWS/SUGAM portals.</div><div>
Working knowledge of ISO 13485, basic FDA regulatory concepts, and international regulatory frameworks.</div><div>
Strong documentation, coordination, and communication skills.</div></div><div></div>

Regulatory Affairs & Compliance Executive

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Regulatory Affairs & Compliance Executive