global regulatory affairs manager

IQVIA

No visa or accommodation sponsorshipYou will be responsible for regulatory activities required at a country level for pharmaceutical products including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval, etc., ensuring regulatory compliance in the applicable market(s).As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients, global pharmaceutical companies.JOB OVERVIEWEssential Functions<ol><li>Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.</li><li>Submit submissions such as renewals, variations, new applications, filings, MAH transfers to the local Health Authority and EMA, and follow up on the local regulatory approval process for designated countries.</li><li>Preparation of local Product Labelling (e.g., SmPC, PIL) in local language for designated countries.</li><li>Artwork review and approval in client systems.</li><li>Manage multiple pharmaceutical products.</li><li>Act as subject matter expert in regulatory processes.</li><li>Acts as a Regulatory Team Leader on more complex projects which may include authoring of regulatory documentation and filling application forms.</li><li>Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned, and discuss customer comments.</li><li>Acts as a Subject Matter Expert in Regulatory knowledge in Chemistry Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.</li><li>Project budget management.</li><li>Give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development.</li><li>Possible exposure to present to clients on complex regulatory processes and bid defense meetings.</li><li>Act as reviewer for regulatory standard operating procedures.</li><li>Prepare and deliver internal regulatory training if required.</li></ol>MINIMUM REQUIRED EDUCATION AND EXPERIENCEExperience: Typically requires 8-10 years of prior relevant experience.Education: Masters Degree in Life Sciences or related discipline.Skills and Abilities:<ul><li>Good understanding of the Research and Development process (Chemistry Manufacturing & Controls) relevant regulatory guidelines.</li><li>Possesses specific regulatory or technical expertise.</li><li>Interpersonal communication (oral and written) and organization skills.</li><li>Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</li><li>Demonstrates self-motivation and enthusiasm.</li><li>Ability to adapt quickly to a rapidly changing environment.</li><li>Knowledge of Maintenance of Marketing Authorization.</li><li>Experience of preparing variation renewal packages and artwork approvals.</li><li>Fluent in English and able to effectively communicate complex business language to those who speak English as a second language.</li><li>Must be fluent in Arabic.</li></ul>IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at<img src="https://www.jobg8.com/Tracking.aspx?%2fh34g3pSz%2f5vcg4ahaTk8lEKzSlsbq%2f%2bp" width="0" height="0" />

Global Regulatory Affairs Manager homebased

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)

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" />

Rawaj - Human Capital Management

<div>Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.
The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.<h3 class="jobSectionHeader">
Key Accountabilities</h3><ul><li>
Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.</li><li>
Manage communication with SFDA authorities for product approvals and renewals.</li><li>
Track and interpret new regulations impacting medical device compliance.</li><li>
Maintain product registration database and ensure documentation accuracy.</li><li>
Collaborate with QA, R&amp;D, and Production to ensure regulatory alignment.</li></ul><h3 class="jobSectionHeader">
Knowledge, Skills, and Experience</h3><ul><li>
Bachelor&rsquo;s degree in Pharmacy, Biomedical Engineering, or Science.</li><li>
8+ years of experience in Regulatory Affairs for medical devices.</li><li>
Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.</li><li>
Strong documentation and submission management skills.</li><li>
Excellent English communication.</li></ul></div>

Regulatory Affairs Manager| Officer – Medical Devices | Saudi Arabia

Human Capital HR Solutions

The Assistant Manager &ndash; Regulatory &amp; Corporate Affairs will ensure full compliance with all statutory and regulatory requirements while supporting the company&rsquo;s legal, licensing, and corporate governance activities. The role requires close coordination with internal departments, legal counsel, and government authorities to maintain a compliant and well-governed business environment.Key Responsibilities:<ul><li>Ensure compliance with local laws, regulatory bodies, and industry standards.</li><li>Manage regulatory filings, licenses, renewals, and statutory documentation.</li><li>Liaise with government departments, legal advisors, and industry associations.</li><li>Support corporate documentation, board meetings, and policy development.</li><li>Prepare and review contracts, agreements, and legal correspondences.</li><li>Facilitate internal and external audits conducted by regulatory authorities.</li><li>Monitor and report on new or updated regulations affecting company operations.</li></ul>Job Type: Full-timePay: Rs120,000.00 - Rs170,000.00 per monthWork Location: In person

Assistant Manager – Regulatory & Corporate Affairs

Amgen

<div>HOW MIGHT YOU DEFY IMAGINATION?
You&rsquo;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&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
CW Associate Regulatory Affairs - based in Dubai
Live
What you will do
Let&rsquo;s do this. Let&rsquo;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 :<ul><li>
Ensures regulatory submissions are made on time and meet Amgen&rsquo;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>
Win
What we expect of you
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.
Basic Qualifications:<ul><li>
Bachelor`s degree in Pharmaceutical Science</li><li>
Working with policies, procedures and SOP&rsquo;s.</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>
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates&rsquo; 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.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.</div>

Associate Regulatory Affairs - based in Dubai

Chalhoub Group

Join to apply for the L'Occitane Regulatory Affairs Trainee role at Chalhoub Group For over seven decades, Chalhoub Group has been a partner and creator of luxury experiences in the Middle East. In its pursuit to excel as a hybrid luxury retailer, the Group has curated a portfolio of over 10 owned brands and strengthened its distribution and marketing expertise for over 400 international names across luxury fashion, beauty, jewellery, watches, eyewear, and art de vivre categories. Every step at Chalhoub Group is taken to build a future where luxury dreams become reality - bridging cultures and crafting memorable experiences for our consumers. By constantly reinventing itself, committing to innovation, and embracing new technologies, the Group is shaping the future of luxury retail. It delivers seamless omnichannel experiences across more than 950 stores, online platforms, and mobile apps. Driving this innovation journey is The Greenhouse - the Group's innovation hub, incubator, and accelerator for startups and emerging businesses, regionally and globally. Chalhoub Group fosters a people at heart culture rooted in diversity, equity, and inclusion, and a workplace catalysed by forward thinking and future proofing. Today, it brings together over 16,000 talented professionals across eight countries in the Middle East, with a presence in LATAM. Their collective efforts have earned the Group the Great Place to Work certification in several markets. Sustainability is at the core of the Group's strategy, guided by a clear commitment to people, partners, and the planet. Chalhoub Group is proud to be a member of the United Nations Global Compact, a signatory of the Women's Empowerment Principles, and to have pledged to reach Net Zero by 2040. What You'll Be Doing <ul> <li>Achieve local registrations for all brands within sister companies in each country.</li> <li>Maintain an informed awareness of Product Registration and Regulatory guidelines. Update and centralize the products registration.</li> <li>Identify constraints and implement product registration for new market openings.</li> <li>Efficiently coordinate and communicate with the Brand, local market, and export team for all regulatory related activities. Follow up and answer additional questions from local teams, suppliers, and certifying bodies.</li> <li>Create contact and good relationships with regulatory authorities, third parties, and certification bodies (Intertek, SGS, Dubai Municipality, ESMA, SFDA, MOH, etc.).</li> </ul> What You'll Need To Succeed <ul> <li>Bachelor's or Master of Science in Industrial Pharmacy/Chemistry/Biotechnology/Pharmaceutical Science.</li> <li>Experience in the cosmetic or pharmaceutical industry, preferably the regulatory/compliance position, would be a plus.</li> <li>Fluent in English is compulsory; Arabic and French would be a plus.</li> <li>Mastering IT tools and basic Excel preferred.</li> </ul> What We Can Offer You With us, you will turn your aspirations into reality. We will help shape your journey through enriching experiences, learning and development opportunities and exposure to different assignments within your role or through internal mobility. Our Group offers diverse career paths for those who are extraordinary, every day. We recognise the value that you bring, and we strive to provide a competitive benefits package which includes health care, child education contribution, remote and flexible working policies as well as exclusive employee discounts. We Invite All Applicants to Apply It takes diversity of thought, culture, background, differing abilities and perspectives to truly inspire, exhilarate and delight our customers. At Chalhoub Group, we are committed to inclusion and diversity. We welcome all applicants to apply and be part of our exciting future. We ensure equal opportunity for all our applicants without regard to gender, age, race, religion, national origin or disability status. Referrals increase your chances of interviewing at Chalhoub Group by 2x. Get notified about new Regulatory Affairs Specialist jobs in Dubai, United Arab Emirates. Dubai, United Arab Emirates<img src="https://www.jobg8.com/Tracking.aspx?vN7mL9eUiCQVgRZ%2bdnkgAMbMyMd7CWHzi" width="0" height="0" />

L'Occitane Regulatory Affairs Trainee

Search 10000+ Global regulatory affairs manager jobs near you this October. New roles added regularly across leading industries. Apply today.

10000 global regulatory affairs manager jobs NEAR_ME

Global Regulatory Affairs Manager homebased

Global Regulatory Affairs Associate Director (Cardio-Metabolic)

Global Regulatory Affairs Associate Director (Cardio-Metabolic)

Regulatory Affairs Manager| Officer – Medical Devices | Saudi Arabia

Assistant Manager – Regulatory & Corporate Affairs

Associate Regulatory Affairs - based in Dubai

L'Occitane Regulatory Affairs Trainee