regulatory affairs lead

<div><div><div><div><div><div><b>Entity:</b> CSL Behring</div>
<div><b>Job Category:</b> Research Development &amp; Sciences</div>
<div><b>Job Family:</b> Global &amp; Regional Regulatory Affairs</div>
<div><b>Job Type:</b> Full Time</div>
<div><b>Location</b><b>:</b> Riyadh, Riyadh, Saudi Arabia</div>
<div><b>Employer Reference:</b> R-266747</div>
</div></div><div></div><h2 class="jobSectionHeader"><b>Job Description</b></h2>
<div><div><div><b>Main Responsibilities and Accountabilities</b></div><div><b>
1. Strategic Focus</b></div><ul><div><div>
Lead the development and execution of regulatory strategies for complex projects across KSA and MEA partner markets:</div></div><div><ul><div><div>
Assess regulatory pathways and identify optimal submission strategies to accelerate approvals while ensuring compliance with local and global requirements.</div></div><div><div>
Anticipate regulatory challenges and proactively design mitigation plans to minimize risks and delays.</div></div><div><div>
Align regulatory strategies with business objectives, product lifecycle plans, and commercial priorities to support timely market access.</div></div><div><div>
Collaborate with cross-functional teams (clinical, quality, manufacturing, commercial) to integrate regulatory considerations into project planning and decision-making.</div></div><div><div>
Drive innovative approaches to meet evolving regulatory requirements and leverage regional insights to influence global strategy.</div></div></ul></div></ul><div></div><ul><div><div><br>
Ensure oversight on key processes and frameworks to manage third-party activities end-to-end, ensuring compliance with regulations and company standards; perform due diligence, monitor partner performance, and address deviations promptly.</div></div></ul><div></div><div><b><br>
2. Technical Regulatory Responsibilities for KSA (in Coordination with Scientific Office Manager)</b></div><ul><div><div>
Responsible for technical regulatory activities in KSA, while coordinating all actions with the Scientific Office Manager for the TSO in Saudi, including:</div></div></ul><ul><div><ul><div><div>
Performing regulatory assessments for new products and variations.</div></div><div><div>
Preparing and compiling complete regulatory dossiers in alignment with SFDA requirements.</div></div><div><div>
Managing electronic submissions through the SDR portal via the Scientific Office in KSA.</div></div><div><div>
Responding to SFDA queries and deficiency letters promptly and effectively.</div></div><div><div>
Ensuring compliance with all local regulatory standards and timelines for approvals.</div></div><div><div>
Maintaining proactive communication with SFDA to facilitate smooth review processes.</div></div></ul></div></ul><div></div><ul><div><div><br>
Also responsible for interaction with distributors and local partners for local manufacturing projects in KSA to ensure all regulatory activities are on track and aligned with compliance requirements.</div></div></ul><div><b>
3. Regulatory Oversight for Partner Markets in MEA (Assigned Markets)</b></div><ul><div><div>
Manage distributors and partners in assigned Partner Business markets.</div></div><div><div>
Prepare regulatory dossiers and provide regulatory assessments for these markets, ensuring compliance with local requirements and company standards.</div></div><div><div>
Ensure distributors submit dossiers to Health Authorities on time and in full compliance with regulatory requirements.</div></div><div><div>
Conduct audits and assessments to ensure compliance with local requirements and quality standards; implement corrective actions and risk mitigation strategies.</div></div><div><div>
Act as RA representative in audits/inspections and ensure readiness and timely CAPA closure.</div></div><div><div>
Serve as escalation point for partner-related issues and align closely with GRA for contract management.</div></div></ul><div><b>
4. Regulatory Intelligence &amp; Authority Interaction</b></div><ul><div><div>
Stay updated on regulatory requirements, guidelines, and industry trends; communicate changes to GRA and local teams.</div></div><div><div>
Communicate with Health Authorities, specifically SFDA, for all regulatory activities as needed, while ensuring coordination with the Scientific Office Manager.</div></div></ul><div><b>
5. Submission Management</b></div><ul><div><div>
Support regional regulatory teams in planning and submission preparation according to local requirements.</div></div><div><div>
Perform preparation and submission of regulatory dossiers, including variations, labeling, and NDAs, ensuring compliance with local regulations.</div></div><div><div>
Demonstrate strong knowledge of eCTD structure and requirements, including publishing tools (e.g., DocuBridge), eCTD compilation, and technical validation.</div></div><div><div>
Ensure familiarity with electronic submission processes through SDR in in Saudi Arabia ; maintain awareness of all technical aspects related to electronic submissions.</div></div></ul><div><b>
6. Systems &amp; Data Integrity</b></div><ul><div><div>
Maintain accurate and timely updates in regulatory systems and databases such as Veeva Vault RIM.</div></div><div><div>
Demonstrate advanced experience in Veeva, including:</div></div></ul><ul><div><ul><div><div>
Managing end-to-end regulatory workflows within Veeva Vault RIM.</div></div><div><div>
Uploading, organizing, and maintaining submission documents in compliance with global and local standards.</div></div><div><div>
Ensuring data integrity and version control for all regulatory records.</div></div><div><div>
Generating reports and dashboards to track submission status and compliance KPIs.</div></div><div><div>
Coordinating with global teams to ensure alignment of Veeva processes across regions.</div></div></ul></div></ul><div><b>
7. Labeling Responsibilities</b></div><ul><div><div>
Experience in end-to-end labeling processes, including country-specific labels and multi-country shared labels.</div></div><div><div>
Ensure compliance with local GCC labeling requirements.</div></div><div><div>
Coordinate labeling activities with other team members for MEA shared labels to ensure timely updates and consistency.</div></div><div><div>
Demonstrate knowledge of GLAMS labeling process and maintain accurate labeling records in the system.</div></div></ul><div><b>
8. Local Manufacturing Projects</b></div><ul><div><div>
Manage local manufacturing partners in KSA to ensure they are updated with the latest technical dossier of the product.</div></div><div><div>
Ensure partners perform regulatory activities on time, including variations, labeling updates, and registration renewals.</div></div><div><div>
Be actively involved in any new initiatives for local manufacturing in KSA and other MEA markets, providing regulatory guidance and support from planning through execution.</div></div></ul><div><b>
9. Stakeholder Management &amp; Training</b></div><ul><div><div>
Act as primary interface with local partners in assigned markets, representing the company&rsquo;s regulatory interests and fostering strong relationships.</div></div><div><div>
Align with commercial in Partner Business Markets to ensure timely and standardized delivery of partner-specific activities.</div></div><div><div>
Monitor training effectiveness and compliance; ensure proper training programs are developed and implemented.</div></div><div><div>
Lead and deliver complex regional strategies across CSL products, ensuring alignment with company and commercial objectives.</div></div><div><div>
Provide guidance for regulatory activities across MEA countries, adapting strategies to local requirements.</div></div></ul><div>
-</div><div><b>
Position Qualifications and Experience Requirements</b></div><div></div><div><b>
Education</b></div><ul><div><div>
Bachelor&rsquo;s degree in pharmacy, life sciences, or related field.</div></div><div><div>
Certifications in quality or vendor management (e.g., CQA, CMQ, CSQP) desirable.</div></div></ul><div></div><div><b><br>
Experience</b></div><ul><div><div>
Minimum 10+ years in regulatory affairs within pharmaceutical, biotechnology, or healthcare industry.</div></div><div><div>
Proven ability to develop and execute regulatory strategies for complex projects.</div></div><div><div>
Strong experience in communication and negotiation with Health Authorities, specifically SFDA.</div></div><div><div>
Hands-on experience in regulatory dossier preparation (variations, labeling, NDAs).</div></div><div><div>
Proficiency in regulatory systems and databases such as Veeva Vault RIM.</div></div><div><div>
Expertise in eCTD structure, publishing tools (e.g., DocuBridge), and electronic submission processes.</div></div><div><div>
Experience managing local manufacturing projects, particularly in KSA.</div></div><div><div>
Regional regulatory experience across multiple MEA countries.</div></div><div><div>
Demonstrated ability to work in a highly matrixed organization and establish successful cross-functional relationships.</div></div><div><div>
Experience in Pharmacovigilance is desirable.</div></div></ul><div></div><div><b><br>
Competencies</b></div><ul><div><div>
Fluent in Arabic and English (oral and written).</div></div><div><div>
Advanced MS Office skills.</div></div><div><div>
Strong organizational, time management, and interpersonal skills in a global environment.</div></div><div><div>
Ability to work independently and collaboratively, with strong problem-solving and decision-making skills.</div></div></ul></div>
</div><h2 class="jobSectionHeader"><b>About CSL Behring</b></h2>
<div>
<div>CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.</div>
<div>CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.</div>
<div>To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.</div>
</div>
<h2 class="jobSectionHeader"><b>Our Benefits</b></h2>
<div>
<div>For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.</div>
</div>
<h2 class="jobSectionHeader"><b>You Belong at CSL</b></h2>
<div>
<div>At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.</div>
<div>To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging</div>
</div>
<h2 class="jobSectionHeader"><b>Equal Opportunity Employer</b></h2>
<div>
<div>CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.</div></div></div></div></div><div></div>

Regulatory Affairs Senior Manager, GRA, RPR MEA

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

Amgen

Associate Regulatory Affairs - based in Dubai <p>Join to apply for the <b>Associate Regulatory Affairs - based in Dubai</b> role at <b>Amgen</b>.</p><p>You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.</p> What You Will Do <p>Let's do this. Let's change the world. In this vital role, you will manage country specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance:</p><ul><li>Ensures regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements</li><li>Reviews promotional and non promotional materials.</li><li>Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.</li><li>Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</li><li>Partners with peers to ensure consistency on procedures.</li></ul> What We Expect Of You <p>We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications.</p> Basic Qualifications <ul><li>Bachelor's degree in Pharmaceutical Science</li><li>Working with policies, procedures and SOPs.</li><li>Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Knowledge of the Gulf legislation and regulations.</li><li>Understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Understanding of drug development.</li><li>Demonstrate ability to work in teams.</li><li>Ability to understand and communicate scientific/clinical information.</li></ul> Preferred Qualifications <ul><li>Regulatory experience of the Gulf Markets.</li><li>Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.</li><li>Experience interacting with regulatory agency in the Gulf markets.</li></ul> What You Can Expect Of Us <p>As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.</p><p>Apply now at </p><p>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</p>

Associate Regulatory Affairs - based in Dubai

Allmed Solutions

<p>We are seeking a highly motivated and detail-oriented professional to join our Regulatory Affairs team. The Assistant Manager &ndash; Regulatory Affairs will play a key role in managing regulatory activities related to medical devices, ensuring full compliance with local and international regulatory standards.</p><p><b>Key Responsibilities:</b></p><ul><li>Develop and implement effective regulatory strategies to support product approvals.</li><li>Manage product registration processes and prepare regulatory documentation.</li><li>Ensure compliance with applicable regulatory requirements and standards.</li><li>Liaise with regulatory authorities for submissions, queries, and approvals.</li><li>Maintain regulatory compliance throughout the entire product lifecycle.</li><li>Provide regulatory guidance and updates to cross-functional teams.</li></ul><p><b>Requirements:</b></p><ul><li><b>Doctor of Pharmacy (Pharm-D)</b> degree.</li><li><b>1&ndash;3 years</b> of experience in Regulatory Affairs, preferably within the <b>medical devices industry</b>.</li><li>Strong communication, documentation, and analytical skills.</li><li>Ability to multitask, prioritize workloads, and meet tight deadlines in a fast-paced environment.</li></ul><p>Job Type: Full-time</p><p>Pay: Rs60,000.00 - Rs150,000.00 per month</p><p>Work Location: In person</p>

Assistant Manager – Regulatory Affairs

PROVEN

Overview <p>Job Title: Government Affairs Manager</p><p>Job Purpose: The Government Affairs Manager will be responsible for developing and maintaining strong relationships with government entities, regulatory bodies, and key stakeholders in Saudi Arabia. The role ensures compliance with local laws and regulations, supports the company's strategic objectives, and advocates for the company's interests in alignment with Saudi Vision 2030.</p> Key Responsibilities <ul><li>Act as the primary point of contact with all regulatory bodies in KSA and other relevant jurisdictions, ensuring timely, accurate, and legally sound responses to inquiries and requirements.</li><li>Oversee all licensing, permit issuance, renewals, and related government processes for the organization, ensuring compliance with applicable laws and regulations.</li><li>Monitor and interpret government policies, regulations, and emerging regulatory bodies; ensure their integration within the Legal function and company operations.</li><li>Develop and maintain the Regulatory Affairs Policy to reflect current legal obligations, compliance standards, and operational practices.</li><li>Collaborate with Corporate Planning, Legal, and other business units to support licensing, regulatory filings, and approvals for existing and new services.</li><li>Represent the company in government meetings, committees, and industry associations while building and maintaining strong networks with ministries, authorities, and key stakeholders.</li><li>Support management in resolving regulatory issues, preparing reports and policy briefs, and advising leadership on regulatory changes and emerging trends.</li><li>Drive engagement with CITC and other regulators, ensuring effective coordination across teams to align regulatory, legal, and operational objectives.</li><li>Ensure compliance with Saudi labor, commercial, and regulatory requirements while supporting Saudization and CSR initiatives in line with national goals.</li><li>Maintain strong working knowledge of all key Saudi government platforms (e.g., Qiwa, GOSI, Muqeem, Mudad, Balady, etc.) and ensure their effective use in company operations.</li></ul> Qualifications & Requirements <ul><li>Bachelor's degree in Public Administration, Political Science, Law, Business Administration, or a related field (Master's preferred).</li><li>Minimum of 7-10 years of experience in government relations, regulatory affairs, or public affairs, preferably in Saudi Arabia.</li><li>Strong understanding of Saudi government structure, regulations, and Vision 2030 initiatives.</li><li>Experience in regulatory filings, compliance processes, and government licensing.</li><li>Excellent networking, communication, and negotiation skills.</li><li>Proven track record of managing regulatory issues and government relations.</li><li>Fluency in Arabic and English (spoken and written).</li></ul> Seniority level <ul><li>Executive</li></ul> Employment type <ul><li>Full-time</li></ul> Job function <ul><li>Legal</li></ul> Industries <ul><li>Business Consulting and Services and Education</li></ul>

Government Affairs Manager (Education Industry)

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

HumanImpact (Hi)

Overview <p>Snr Manager Real Estate Regulatory Affairs will be leading and further developing the Real Estate Regulation Department. Reporting to the Head of Lands and Properties, successful candidate will directly oversee the four sections' managers and lead all department affairs related to real estate development and free zones in the emirate; contribute to policy and regulatory development; and prepare and implement strategic and operational plans to support the emirate's vision for the real estate sector.</p><p>Main competencies required for this role are strategic focus in formulating and shaping the policies and regulations as well as strong capabilities in developing, monitoring, and evaluating KPIs.</p> Key Responsibilities <ul><li>Develop, update and implement strategic plans, organizational goals and annual operational plans in line with the emirate's strategic directions</li><li>Formulate real estate laws, policies, and frameworks that guide the emirate's development landscape</li><li>Define KPIs for both regulatory compliance and departmental performance</li><li>Review, analyze, and monitor project finances, ROI, and sales data for real estate projects to support regulatory decision-making</li><li>Oversee the evaluation of real estate projects, ensuring financial soundness and alignment with regulations</li><li>Strengthening relationships with internal and external stakeholders (Economic Department, developers, investors, relevant emirate entities) and ensuring high standards of service delivery</li><li>Monitor local and international best practices in real estate regulation and propose regulatory improvements and executive regulations</li><li>Participate in preparation of the department budget and propose policies and special laws to support the real estate market and land sector</li><li>Represent the department in real estate development committees and provide expert consultations and recommendations</li><li>Prepare reports, recommendations and submissions for senior management and executive authorities</li></ul> Key requirements <ul><li>Willing and able to work in the Emirate of RAK</li><li>UAE National or Arabic speaking expat</li><li>Bachelor's degree in relevant field. (Master's degree preferred)</li><li>7-12 years' experience within the <b>UAE government sector</b>, ideally in regulatory or real estate-related authorities or <b>real estate developers</b> (especially master developers) or <b>Joint Owner Associations (JOAs)</b></li><li>Solid grasp of local laws, regulations, and real estate practices</li><li>Deep knowledge of <b>real estate development processes</b> (planning, approvals, execution, and compliance)</li><li>Proven experience in <b>policy creation</b> and regulatory framework development</li><li>Solid financial acumen, with the ability to analyze ROI, project budgets, and sales data</li><li>Understanding of <b>market dynamics</b> and regulatory impact on development projects</li><li>Demonstrated ability to lead cross-functional teams and manage managers</li><li>Strong decision-making and problem-solving capabilities, with a track record of driving regulatory compliance and stakeholder satisfaction</li></ul>

Snr Manager - Real Estate Regulatory Affairs - Public Sector (Arabic speaking)

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