regulatory affairs associate

GlaxoSmithKline

Overview Position Summary: We are inviting UAE Nationals to join our Regulatory Affairs team in the United Arab Emirates as a Regulatory Affairs Associate. This role is crucial in ensuring compliance with local regulations while supporting product lifecycle management and regulatory submissions. You'll collaborate with cross-functional teams to align regulatory strategies with business goals and contribute to meaningful work that improves lives. Key Responsibilities <ul><li>Preparing, coordinating, and submitting regulatory documents in compliance with local regulations and GSK standards.</li><li>Ensuring timely submissions and approvals to support product launches and lifecycle maintenance.</li><li>Collaborating with internal teams and external stakeholders to align regulatory strategies with business objectives.</li><li>Maintaining regulatory databases and ensuring accurate record-keeping in line with compliance requirements.</li><li>Monitoring changes in local regulations and ensuring adherence to applicable laws and guidelines.</li><li>Providing regulatory guidance to cross-functional teams to support business operations.</li></ul> Basic Qualifications <ul><li>UAE National.</li><li>Bachelor's degree in pharmacy, Medicine, or a related field.</li><li>Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).</li><li>Strong attention to detail and organizational skills.</li><li>Effective communication skills, both written and verbal.</li><li>Ability to work collaboratively in a team environment.</li></ul> Preferred Qualifications <ul><li>Previous experience in regulatory affairs or a related field.</li><li>Familiarity with regulatory submission processes and local guidelines.</li><li>Strong problem-solving skills and the ability to prioritize tasks effectively.</li><li>Interest in the pharmaceutical industry and regulatory compliance.</li><li>Ability to adapt to a fast-paced and dynamic work environment.</li><li>Commitment to continuous learning and professional development.</li></ul> Additional Information This role is based on-site in the United Arab Emirates. GSK is an equal opportunity employer and values diversity, equity, and inclusion. We welcome applications from UAE Nationals who are passionate about improving lives and ensuring compliance with local regulations. Application Process If you're ready to grow your skills, make a positive impact, and contribute to GSK's mission, apply today! Why GSK? Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Contact information You may apply for this position online by selecting the Apply now button. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.<img src="https://www.jobg8.com/Tracking.aspx?GNl9oJpztr%2bFZiP5ZjITpj8ABsc%2f7ueRk" width="0" height="0" />

Regulatory Affairs Associate

<div>Site Name: UAE - Dubai 
Posted Date: Oct 23 2025 
Position Summary: 
We are inviting UAE Nationals to join our Regulatory Affairs team in the United Arab Emirates as a Regulatory Affairs Associate. This role is crucial in ensuring compliance with local regulations while supporting product lifecycle management and regulatory submissions. You&rsquo;ll collaborate with cross-functional teams to align regulatory strategies with business goals and contribute to meaningful work that improves lives.
Key Responsibilities: 
In this role, you will have the opportunity to develop your career while leading key activities such as:<ul><li>
Preparing, coordinating, and submitting regulatory documents in compliance with local regulations and GSK standards.</li><li>
Ensuring timely submissions and approvals to support product launches and lifecycle maintenance.</li><li>
Collaborating with internal teams and external stakeholders to align regulatory strategies with business objectives.</li><li>
Maintaining regulatory databases and ensuring accurate record-keeping in line with compliance requirements.</li><li>
Monitoring changes in local regulations and ensuring adherence to applicable laws and guidelines.</li><li>
Providing regulatory guidance to cross-functional teams to support business operations.</li></ul>
Basic Qualifications: 
To be successful in this role, you should have the following qualifications:<ul><li>
UAE National.</li><li>
Bachelor&rsquo;s degree in pharmacy, Medicine, or a related field.</li><li>
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).</li><li>
Strong attention to detail and organizational skills.</li><li>
Effective communication skills, both written and verbal.</li><li>
Ability to work collaboratively in a team environment.</li></ul>
Preferred Qualifications: 
We value candidates who bring additional skills and characteristics, such as:<ul><li>
Previous experience in regulatory affairs or a related field.</li><li>
Familiarity with regulatory submission processes and local guidelines.</li><li>
Strong problem-solving skills and the ability to prioritize tasks effectively.</li><li>
Interest in the pharmaceutical industry and regulatory compliance.</li><li>
Ability to adapt to a fast-paced and dynamic work environment.</li><li>
Commitment to continuous learning and professional development.</li></ul>
Additional Information: 
This role is based on-site in the United Arab Emirates. GSK is an equal opportunity employer and values diversity, equity, and inclusion. We welcome applications from UAE Nationals who are passionate about improving lives and ensuring compliance with local regulations.
Application Process: 
If you&rsquo;re ready to grow your skills, make a positive impact, and contribute to GSK&rsquo;s mission, apply today!
Why GSK? 
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Contact information:
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.</div>

A global biopharma company is seeking a Regulatory Affairs Associate in Dubai, UAE. This role involves ensuring compliance with local regulations and collaborating with teams to support product lifecycle management. Ideal candidates are UAE Nationals with a degree in pharmacy or medicine and proficiency in Microsoft Office. Strong attention to detail and effective communication skills are essential. The role is based on-site and offers an opportunity to contribute to meaningful work improving lives.<img src="https://www.jobg8.com/Tracking.aspx?JwjScu8ixlLAZuhQiNnZSp8pyE5NkWB%2bu" width="0" height="0" />

Regulatory Affairs Associate: Submissions & Compliance

Novartis Farmacéutica

Choose LocationChoose Location# Global Regulatory Affairs Associate Director (Cardio-Metabolic)REQ-Oct 14, 2025United Kingdom Summary (12 days per month on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Associate Director We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team.The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle. About the Role Major accountabilities: Lead the implementation of regulatory strategies and operational activities across major global regions. Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents. Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams. Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials. Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans). Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals. Develop and implement strategies to minimize review delays and regulatory clock stops. Ensure timely and compliant responses to HA queries and requests. Contribute to departmental goal setting and lead initiatives to improve regulatory processes. Ensure adherence to internal policies, SOPs, and global regulatory requirements. Minimum requirements: Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field. Significant experience in regulatory affairs within the pharmaceutical industry. Proven track record in project management and regulatory operations. Experience representing the organization in cross-functional and cross-cultural settings. Strong knowledge of clinical trials, drug development, and regulatory compliance. Excellent problem-solving, negotiation, and communication skills. Detail-oriented with the ability to manage complex regulatory projects. Skilled in risk management and working with cross-functional teams. Ability to navigate and influence Health Authority interactions. Fluency in English (written and spoken) is essential. Commitment to Diversity and Inclusion/EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis: Join our Novartis Network: Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:DevelopmentUniversal Hierarchy NodeUnited KingdomLondon (The Westworks)GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.Research & DevelopmentFull timeRegularNoNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.REQ- Global Regulatory Affairs Associate Director (Cardio-Metabolic)<img src="https://www.jobg8.com/Tracking.aspx?n70Gs5vBCd8IWwUuLMXZlaNb9isvX8%2f5f" width="0" height="0" />

Global Regulatory Affairs Associate Director (Cardio-Metabolic)

BioMarin Pharmaceutical

<div>Who We Are
 
 
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. 
 
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. 
 
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best &ndash; people with the right technical expertise and a relentless drive to solve real problems &ndash; and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we&rsquo;ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
 
 
About Worldwide Research and Development
 
 
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
Regulatory Affairs Associate - Turkey<ul><li>
Fixed Term Temporary position for up to 7 months (Maternity Leave Cover)</li><li>
Bachelors degree in Pharmacy, Chemical Engineering, Chemistry.</li><li>
Minimum 1 years of Regulatory Affairs experience in a pharmaceutical company,</li><li>
Excellent command of English (both written and spoken),</li><li>
Strong commitment to compatibility, scientific quality and integrity</li><li>
Analytical thinking</li><li>
Good communication and teamwork collaboration</li><li>
Good detail-capturing skills while working in a fast-moving environment</li><li>
Role is based in Turkey</li></ul><div>
JOB DESCRIPTION</div><ul><li>
Submission of Health Authority applications for registered and non-registered products and follow approval process. (GMP applications, new Marketing Authorization (MA) application, renewal submissions, lifecycle activities etc.)
</li><li>Compile all required documents received from Global Headquarters and prepare submission dossiers according to local requirements and make timely applications.
</li><li>Conduct the correspondences for all registered/non-registered products and follow up the Health Authority processes.</li><li>
Assist in managing global/local projects.</li><li>
Ensure the databases are updated on a timely basis.</li><li>
Evaluate local regulations/guidance for impact to any complex submission (e.g., MA, GMP) while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards.</li></ul>
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled 
 
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.</div>

Regulatory Affairs Associate - (Fixed Term Maternity Cover)

Healthcare Businesswomens Association

Job Description Summary (12 days per month on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Associate Director Job Description We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team. The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle. Major Accountabilities <ul> <li>Lead the implementation of regulatory strategies and operational activities across major global regions.</li> <li>Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents.</li> <li>Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams.</li> <li>Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials.</li> <li>Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans).</li> <li>Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals.</li> <li>Develop and implement strategies to minimize review delays and regulatory clock stops.</li> <li>Ensure timely and compliant responses to HA queries and requests.</li> <li>Contribute to departmental goal setting and lead initiatives to improve regulatory processes.</li> <li>Ensure adherence to internal policies, SOPs, and global regulatory requirements.</li> </ul> Minimum Requirements <ul> <li>Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.</li> <li>Significant experience in regulatory affairs within the pharmaceutical industry.</li> <li>Proven track record in project management and regulatory operations.</li> <li>Experience representing the organization in cross-functional and cross-cultural settings.</li> <li>Strong knowledge of clinical trials, drug development, and regulatory compliance.</li> <li>Excellent problem-solving, negotiation, and communication skills.</li> <li>Detail-oriented with the ability to manage complex regulatory projects.</li> <li>Skilled in risk management and working with cross-functional teams.</li> <li>Ability to navigate and influence Health Authority interactions.</li> <li>Fluency in English (written and spoken) is essential.</li> </ul> Commitment to Diversity and Inclusion/EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Skills Desired <ul> <li>Clinical Trials</li> <li>Cross-Functional Teams</li> <li>Detail-Oriented</li> <li>Drug Development</li> <li>Lifesciences</li> <li>Negotiation SkillsProblem Solving SkillsRegulatory ComplianceRisk Management</li> </ul><img src="https://www.jobg8.com/Tracking.aspx?vAeLusD9WE0pILu4uWEJNiiMBr948H6fb" width="0" height="0" />

Peergrowth Consultancy Co.

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at our UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including support for GMP audits. The ideal candidate will collaborate closely with Quality Assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams. Experience with local UAE and GCC regulatory requirements is preferred, with an understanding of global CTD requirements.KEY RESPONSIBILITIES<ul><li>Collate, compile, and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.</li><li>Ensure accuracy, completeness, and regulatory compliance of all documentation submitted.</li><li>Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.</li><li>Act as a key liaison between regional regulatory teams and site-based technical functions (QA, QC, Production, Engineering).</li><li>Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.</li><li>Maintain an organized and up-to-date archive of all regulatory submissions made from the site.</li><li>Implement proper version control, submission tracking, and document retrieval protocols.</li><li>Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.</li><li>Ensure alignment with both international regulatory expectations and local UAE / GCC requirements.</li><li>Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.</li><li>Support documentation requests for internal audits, inspections, and compliance reviews.</li></ul>CANDIDATE EXPERIENCE<ul><li>Bachelors or masters degree in pharmacy (preferred)</li><li>2 to5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry.</li><li>Preferred : Experience with handling guidelines of UAE Ministry of Health (MoHAP), GCC-DR, Oman, Bahrain, or other Gulf regulatory bodies.</li><li>Practical knowledge of CTD / eCTD dossier formats and GMP audit preparation.</li></ul>Key Skills and Competencies<ul><li>Strong communication, collaboration, and coordination skills across technical and regulatory functions.</li><li>High level of accuracy, attention to detail, and document management capabilities.</li><li>Ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements.</li><li>Proficient in Microsoft Office (Word, Excel, PowerPoint) and document control systems.</li><li>Proactive approach to problem-solving and handling regulatory queries.</li></ul>Coordinator • Dubai, United Arab Emirates<img src="https://www.jobg8.com/Tracking.aspx?zVcfVDlfDotLNFq0K%2b68Cho%2fqss4iFlXs" width="0" height="0" />

Regulatory Affairs Coordinator

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Regulatory Affairs Coordinator