regulatory affairs manager

Gilead Sciences

<div>
 At Gilead, we&rsquo;re creating a healthier world for all people. For more than 35 years, we&rsquo;ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer &ndash; working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world&rsquo;s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 
 
 Every member of Gilead&rsquo;s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we&rsquo;re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 
 
 We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
 
 
 
 Job Description
 
 
 
 Regulatory Affairs Manager Turkiye; is responsible from managing RA submissions &amp; supporting Clinical Trials applications and will serve as a core member of the affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country&rsquo;s applicable legislations.
 
 
 
 Knowledge &amp; Details
 
 
 
 <ul>
 <li>
 Manage regulatory submissions to local HA submissions inc. but not limited to Pre-MAA related activities (GMP &amp; prioritization applications), marketing Authorisation (MA) applications &amp; variations and other MA maintenance applications, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.
 </li>
 <li>
 Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.
 </li>
 <li>
 Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.
 </li>
 <li>
 Manage clinical trial applications, amendments, and notifications. Collaborate with Clinical Operations and the CT Hub to complete CT submissions to MOH timely and interacts with cross-functional teams internally and externally to ensure submission package fulfils the MoH requirements on time.
 </li>
 <li>
 Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.
 </li>
 <li>
 Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.
 </li>
 <li>
 Ensure good and strong relationships with functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with Gilead Sciences Global/Regional RA in order to ensure the success of local and international business results from the regulatory point of view.
 </li>
 <li>
 Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.
 </li>
 <li>
 Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.
 </li>
 <li>
 Actively contribute to local and global initiatives that improve regulatory processes.
 
 
 </li>
 </ul>
 
 Professional Experience / Key Skills
 
 
 
 <ul>
 <li>
 Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.
 </li>
 <li>
 Degree in Pharmaceutical Sciences or equivalent discipline is preferred.
 </li>
 <li>
 Proven ability to prioritize, conduct, and manage time to meet project deadlines.
 </li>
 <li>
 Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.
 </li>
 <li>
 Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.
 </li>
 <li>
 Strong focus on achievement of goals and continuous improvement
 </li>
 <li>
 Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.
 </li>
 <li>
 Having excellence in multiple project management, good communication and interpersonal skills.
 </li>
 <li>
 Be an analytical thinker, problem solver, proactive, initiative taker, creative personality
 </li>
 <li>
 Team player who actively contributes to the team in order to complete tasks, meet goals or manage projects, actively listen others, respect ideas and aim to improve the process.
 </li>
 <li>
 Fluency in spoken and written English.
 </li>
 <li>
 Good decision-making skills are important.
 </li>
 <li>
 Excellent verbal, written, organization skills and interpersonal communication skills required.
 
 
 </li>
 </ul>
 Equal Employment Opportunity (EEO)
 
 
 It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual&rsquo;s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
 
 
 
 For Current Gilead Employees And Contractors
 
 
 
 Please apply via the Internal Career Opportunities portal in Workday.
</div>

Regulatory Affairs Manager

IQVIA

<div>Join IQVIA and help shape the future of global healthcare. As a Global Regulatory Affairs Manager, you will ensure compliance and accelerate access to therapies across international markets.
What You Will Do
<ul><li>Develop and implement regulatory strategies for assigned products in partnership with global teams and local affiliates.
</li><li>Manage submissions, approvals, and lifecycle activities to meet timelines and regulatory requirements.
</li><li>Act as the key liaison between global regulatory teams and affiliates, ensuring alignment on priorities and documentation.
</li><li>Monitor regulatory changes and provide strategic guidance to internal stakeholders.
</li><li>Support health authority interactions, including briefing documents and response planning.
</li></ul>What You Will Bring
<ul><li>Degree in Pharmacy or Life Sciences.
</li><li>Experience in regulatory affairs across international markets.
</li><li>Strong communication and collaboration skills.
</li><li>Proficiency in regulatory systems such as Veeva RIM.
</li><li>A proactive, solution-oriented mindset.
</li></ul>Why IQVIA
Your potential has no limits here. We thrive on innovation, collaboration, and a shared mission to advance healthcare worldwide. Join us and make an impact that matters.
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>

Global Regulatory Affairs Manager

<div>Join IQVIA and help shape the future of global healthcare. As a Global Regulatory Affairs Manager, you will ensure compliance and accelerate access to therapies across international markets.
What You Will Do<ul><li>
Develop and implement regulatory strategies for assigned products in partnership with global teams and local affiliates.</li><li>
Manage submissions, approvals, and lifecycle activities to meet timelines and regulatory requirements.</li><li>
Act as the key liaison between global regulatory teams and affiliates, ensuring alignment on priorities and documentation.</li><li>
Monitor regulatory changes and provide strategic guidance to internal stakeholders.</li><li>
Support health authority interactions, including briefing documents and response planning.</li></ul>
What You Will Bring<ul><li>
Degree in Pharmacy or Life Sciences.</li><li>
Experience in regulatory affairs across international markets.</li><li>
Strong communication and collaboration skills.</li><li>
Proficiency in regulatory systems such as Veeva RIM.</li><li>
A proactive, solution-oriented mindset.</li></ul>
Why IQVIA
Your potential has no limits here. We thrive on innovation, collaboration, and a shared mission to advance healthcare worldwide. Join us and make an impact that matters.
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>

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

Global Regulatory Affairs Manager (homebased)

CbayExpress Corporation

Position: Senior Regulatory Affairs Manager &ndash; Global Cosmetics ComplianceDepartment: Regulatory Affairs / Operations Reports to: COO (Integrator) &amp; CEO Type: Full-timeAbout CBAYEXPRESS / HerbishhCBAYEXPRESS CORPORATION is a Canadian-based e-commerce company selling across Amazon (US, CA, MX, UK, EU, AU, SG, IN, UAE), Walmart, Shopify (Herbishh.com, BisonBody.com), eBay, and other marketplaces.Our flagship brand Herbishh is a leader in haircare and beauty, with rapid global expansion. With $15M+ annual revenue, we are scaling towards $30M+ globally, and compliance is a key pillar of our success.Role OverviewWe are seeking a Senior Regulatory Affairs Manager to lead our global compliance function. This role will oversee all cosmetic regulatory filings, manage internal staff, coordinate with external agencies, and ensure all products are registered and compliant in every market.This is a leadership role responsible for building a robust compliance system that enables faster launches, minimizes regulatory risks, and supports global scale.Key Responsibilities1. Leadership &amp; Oversight<ul><li>Lead the global Regulatory Affairs team</li><li>Supervise, mentor, and review their work to eliminate errors.</li><li>Act as the final authority for all compliance decisions.</li></ul>2. Global Compliance Management<ul><li>Ensure product compliance with MOCRA (US FDA), Health Canada, EU CPNP/SCPN, UK SCPN, COFEPRIS (Mexico), UAE ESMA, AU NICNAS, India BIS and other authorities.</li><li>Develop and enforce compliance SOPs across departments.</li><li>Maintain a master compliance tracker (per SKU, per market).</li></ul>3. Agency &amp; Consultant Coordination<ul><li>Manage Angel Consulting (USA, UK, EU) and other regional agencies (UAE, AU).</li><li>Provide agencies with accurate data and monitor their progress.</li><li>Review filings before submission to ensure correctness.</li></ul>4. Documentation &amp; Systems<ul><li>Oversee preparation and review of SDS, COA, HRIPT, ingredient lists, labeling, claims, packaging proofs.</li><li>Maintain an organized digital compliance library for all SKUs.</li><li>Conduct quarterly compliance audits.</li></ul>5. Cross-Functional Collaboration<ul><li>Work with Product Development to validate feasibility before new launches.</li><li>Support Inventory &amp; Logistics with customs compliance.</li><li>Advise Marketing team on claim restrictions and labeling.</li><li>Partner with Finance on import/export regulatory risks.</li></ul>6. Risk &amp; Expansion Strategy<ul><li>Stay updated on upcoming regulatory changes (e.g., new MOCRA guidelines, EU ingredient bans).</li><li>Proactively flag risks and recommend solutions for smooth market entry.</li><li>Develop long-term plan to reduce agency dependency by strengthening in-house capability.</li></ul>KPIs / Success Metrics<ul><li>% of new product launches completed on-time without compliance delays.</li><li>Reduction in compliance-related errors from internal team.</li><li>Zero instances of customs holds or Amazon suspensions due to compliance issues.</li><li>Accuracy and completeness of compliance documentation.</li><li>Agency turnaround times consistently met.</li></ul>Requirements<ul><li>7&ndash;10 years experience in cosmetics / personal care regulatory affairs.</li><li>Deep knowledge of global cosmetic regulations (US, Canada, EU/UK, Mexico, UAE, AU, India).</li><li>Proven track record in managing product registrations across multiple markets.</li><li>Strong leadership skills &mdash; able to mentor junior staff and manage agencies.</li><li>Highly detail-oriented, organized, and process-driven.</li><li>Excellent communication skills (English mandatory).</li></ul>Nice-to-Have<ul><li>Prior experience in Amazon / D2C beauty brands.</li><li>Background in chemistry, pharmacy, or cosmetic science.</li><li>Familiarity with regulatory software &amp; compliance trackers.</li><li>Spanish language (for Mexico filings).</li></ul>What We Offer<ul><li>Competitive salary</li><li>Opportunity to lead compliance for a global beauty brand.</li><li>Work directly with CEO &amp; COO on strategy and expansion.</li><li>Career path towards Head of Regulatory / Director-level role.</li><li>Fast-paced, multicultural, remote-first team.</li></ul>Job Types: Full-time, PermanentPay: &#8377;1,200,000.00 - &#8377;1,500,000.00 per yearBenefits:<ul><li>Health insurance</li><li>Paid time off</li><li>Provident Fund</li></ul>Application Question(s):<ul><li>Notice Period:</li><li>Current Location:</li></ul>Experience:<ul><li>Global Ecommerce: 3 years (Preferred)</li><li>MoCRA: 3 years (Preferred)</li><li>Cosmetics Regulatory: 3 years (Preferred)</li></ul>

Senior Regulatory Affairs Manager — Global Cosmetics Compliance

Roche

<div>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.<div>
The Position</div>
A healthier future. It&rsquo;s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That&rsquo;s what makes us Roche.
At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Our team is tasked with regulatory projects as well as overarching regulatory topics with specific focus in Companion Diagnostics. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.
As a Regulatory Affairs Manager focused on Companion Diagnostics (CDx), with specific focus on systems and software, you will be the key strategic partner driving market access for our life-changing IVD products in major global markets, primarily the US and Europe.
The Opportunity<ul><li>
You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs. You develop and manage parts of comprehensive global regulatory submissions and registration plans.<ul><li>
For this specific role, you ensure that Roche IVD products, systems and software, particularly Companion Diagnostics, receive timely regulatory clearance/approval in your areas of responsibility (focusing on the US and Europe) by working in close cooperation with other regulatory units.</li></ul></li><li>
You interface with external management. You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders. You build effective and enduring external relationships and apply effective stakeholder management practices. You contribute to audits by supporting preparation, execution and follow up.</li><li>
You lead the organization to adapt to the evolving regulatory environment and requirements. You have an understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. You have the ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance. You proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.</li><li>
You effectively partner with external and internal stakeholders to understand and provide best solutions. You take initiative to address problems or opportunities and involve collaborators for best solutions. You develop relationships that significantly influence the current and future direction for Roche and our products.</li><li>
You have courage to make decisions even outside of scope/comfort zone and proactively initiate activities independently. You embrace good decision making principles.</li><li>
You model VAAC Leadership and agility. You identify opportunities to develop VACC competency. You act with integrity, courage, passion and honor commitments and contribute to an inclusive environment.</li><li>
You are able to pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes. You address and resolve conflict by creating an atmosphere of openness and trust. You bring out the best in people and teams.</li></ul>
Who you are<ul><li>
You have a Bachelor&rsquo;s / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.</li><li>
You have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.</li><li>
You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.</li><li>
You have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.</li><li>
You have demonstrated the ability to manage more complex work and/or at parts of global projects.</li><li>
Experience in Companion Diagnostics is required.</li><li>
Experience with Systems, Instruments or Software is required.</li></ul>
Locations
You are local to Tucson, Indianapolis, Branchburg, or Penzberg.
No relocation benefits are available for this position.
The expected salary range for this position based on the primary location of Tucson Arizona is $103,900 and $193,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits<div>
Who we are</div>
A healthier future drives us to innovate. Together, more than 100&rsquo;000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. 
Let&rsquo;s build a healthier future, together.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.</div>

Regulatory Affairs Manager - CDx Systems & Software

DEVA Holding A.Ş.

<div>
 
 DEVA has been operating since 1958 and is one of the pioneering pharmaceutical companies in Turkey. DEVA, having R&amp;D in focus, manufactures with international quality standards and currently exports products to other countries worldwide.
 
 
 
 
 
 DEVA is seeking for an
 
 International Regulatory Affairs Assistant Manager
 
 ;
 
 
 
 
 <ul>
 <li>
 University degree in science fields, Biology, Chemistry, Pharmacy, Chemical Engineering,
 </li>
 <li>
 Fluency in both written and spoken English, a second language desirable,
 </li>
 <li>
 International Markets Regulatory Affairs experience in a pharma company over 8 years is a must, preferably for territories Balkanian countries, CIS, LATAM, MENA, Far East and GCC-Arabic countries,
 </li>
 <li>
 Experience in team leadership/management,
 </li>
 <li>
 Strong leadership and communication/influencing skills,
 </li>
 <li>
 Excellent project management and follow-up skills,
 </li>
 <li>
 Multi tasking/coordination skills,
 </li>
 <li>
 Good communication and interpersonal skills,
 </li>
 <li>
 Analytical thinker, problem solver,
 </li>
 <li>
 Proactive, initiative taker, creative personality,
 </li>
 <li>
 Cross-cultural sensitivity,
 </li>
 <li>
 No military obligation for male applicants.
 </li>
 </ul>
 
 
 
 
 
 JOB DESCRIPTION
 
 
 <ul>
 <li>
 Management of submission of the marketing authorization application dossiers to the Ministry of Health of the relevant countries operating in the International Markets as per given timeline and portfolio,
 </li>
 <li>
 Coordinating all activities related to deficiency letters and preparing answers properly,
 </li>
 <li>
 Management of preparation and submission of renewal dossiers, follow up variations,
 </li>
 <li>
 Prepare priority submissions for GMP and company registration,
 </li>
 <li>
 Closely following international regulations and legislations,
 </li>
 <li>
 Giving support to related departments on subject related to Regulatory knowledge and procedures,
 </li>
 </ul>
 
 
 
 
 
 Bir &ccedil;al&inodot;&scedil;an aday&inodot; olarak, sizinle aram&inodot;zdaki t&uuml;m ileti&scedil;imde bilgilerinizi 6698 say&inodot;l&inodot; Ki&scedil;isel Verilerin Korunmas&inodot; Kanunu&rsquo;na, yasal mevzuata ve Ki&scedil;isel Verileri Koruma Kurumu kararlar&inodot;na uygun olarak i&scedil;liyoruz. Detayl&inodot; bilgiye ve ayd&inodot;nlatma metnimize link &uuml;zerinden ula&scedil;abilirsiniz. https://www.deva.com.tr/tr/kvkk
 
 
</div>

International Markets Regulatory Affairs Assistant Manager

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