regulatory affairs associate

Ferring Pharmaceuticals, Inc.

<div><div>Job Description:</div><div>
Regulatory Affairs Associate</div><div></div><div>
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women&rsquo;s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.</div><div>
Joining our Regulatory team, you will be part of an empowering and collaborative culture where your work plays a key role in ensuring patient safety, regulatory compliance and sustainable access to medicines. By working closely with cross-functional teams and external stakeholders, you will support regulatory excellence, life-cycle management and the consistent maintenance of our portfolio. Your contribution helps ensure that high-quality therapies remain available, compliant and trusted throughout their entire life cycle.</div><div></div><div>
Ferring+You</div><div></div><div>
We are looking for a Regulatory Affairs Associate to join our team and take a key role in regulatory compliance, quality assurance, document governance, and cross-functional business support in line with local regulations and global procedures, reporting directly to the Regulatory Affairs Manager.</div><div></div><div>
Your day at Ferring</div><ul><li><div>
Act as Document Accountable Person (DAP) and Document Controller (DC), ensuring document lifecycle management, consistency, and compliance</div></li><li><div>
Serve as the main local regulatory contact and manage regulatory compliance activities</div></li><li><div>
Coordinate new drug approvals, including dossier preparation, submissions, and follow-up with local Health Authorities</div></li><li><div>
Manage regulatory submissions, variations, renewals, and product lifecycle activities</div></li><li><div>
Support and coordinate regulatory inspections and maintain validity of licenses and certificates</div></li><li><div>
Monitor regulatory intelligence, assess impact, and proactively communicate regulatory changes</div></li><li><div>
Ensure timely and accurate updates in global and local regulatory systems (e-CTD, Veeva Vault, Track Wise, etc.)</div></li><li><div>
Prepare, review, and approve artworks and labeling to support submissions and product launches</div></li><li><div>
Review promotional and non-promotional materials in line with local regulations and global procedures</div></li><li><div>
Support Quality Management System (QMS) implementation and sustainability, including local market release</div></li><li><div>
Support regulatory and pricing applications, including document coordination and pricing data monitoring</div></li></ul><div></div><div>
Behind our collaboration&hellip;There&rsquo;s you</div><ul><li><div>
University degree in Pharmacy</div></li><li><div>
Min. 2-3 years of practical experience in regulatory and quality assurance</div></li><li><div>
Know-how of interactions with regulatory authorities</div></li><li><div>
Experience with e-CTD, Veeva Vault, Track Wise, and pricing is a plus</div></li><li><div>
Eager to learn personality, team player approach, attention to details</div></li><li><div>
Fluent in English language (written and verbal)</div></li></ul><div></div><div>
People come first at Ferring</div><div></div><ul><li><div>
Get inspired from our commitment to advocate for everyone&rsquo;s right to build a family, no matter who you are, where you live or who you love</div></li><li><div>
Our inclusive support package &ndash; &ldquo;Building Families at Ferring&rdquo; provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role</div></li><li><div>
Parental leave for both birthing and non-birthing parents</div></li><li><div>
Extended support on family building journey</div></li></ul><div></div><div>
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member&rsquo;s contributions. Imagine the power of your career when it&rsquo;s Ferring + You.</div><div></div><div>
Behind our purpose&hellip; There&rsquo;s you</div><div>
If our mission and your vision are aligned, please apply.</div><div>
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.</div><div></div><div>
Location:</div>
Ferring Turkey</div>

Regulatory Affairs Associate

Kraft Heinz

<p></p><div><div><div><div><div><div><div><div><div><ul><div><b>All Posting Locations:</b> Besiktas, Istanbul, TR
</div><div><b>Job Functions:</b> Quality</div>
<div><b>Date Published:</b> December 30, 2025</div>
<div><b>Ref#:</b> R-97518</div></ul><div></div><div><br>
</div></div></div></div></div></div></div></div></div><p></p><div><div><div><div><div><div>ABOUT THE ROLE</div></div><div><div>
Job Description</div>
<p><b>About the Position</b></p>
<p>Regulatory Affairs Associate Manager ensuring Food Regulatory Compliance and enabling market access for products. Managing product registrations with authority, as well as reviewing, verifying product information and coordinating documentation for regulatory submissions. Supporting regulatory strategies, maintaining strong relationships with local authorities and internal stakeholders to support business growth. Monitoring and analyzing legislative/regulation changes and their impact on our products- brands- and organization. Presenting the organization in various trade associations and industry groups to proactively manage food regulatory advocacy as well as keeping internal stakeholders informed through continuous monitoring of emerging regulations. You&rsquo;ll be directly reporting into Head of Regulatory Affairs &ndash; East &amp; dotted-line reporting to Head of Legal T&uuml;rkiye.</p>
<p><b>Key Responsibilities</b></p>
<ul><li><p>Check the compliance of the products&rsquo; labels in Turkey against the relevant legislations- government guidelines and company policies. All brands the company produces and imports.</p>
</li><li><p>Check the compliance of the health and nutritional and other claims against the relevant legislation.</p>
</li><li><p>Support the Marketing team in providing and approving legislation of the products&rsquo; information relating to product functional &ndash; health &ndash; nutritional claims including ads and online marketing.</p>
</li><li><p>Provide information and advice on legislation for product formulation- packaging- and labelling issues.</p>
</li><li><p>Prepare product registration files with claim substantiation docs and follow up till registration is done.</p>
</li><li><p>Be in direct contact with distributors or get support from 3rd party companies (for export destinations) to support and understand any new regulatory updates/ requirements.</p>
</li><li><p>Support the business with regulatory information relating to products produced and sold in other regions.</p>
</li><li><p>Work with cross country teams to ensure regulatory compliance of export and import products including filling necessary applications.</p>
</li><li><p>Leading Regulatory Horizon Scanning for upcoming regulatory related changes for the business. Build and maintain relationships with the relevant industrial groups, authorities, and global horizon scan team to maintain awareness of new food legislations.</p>
</li><li><p>Leading Proactive &ndash; Raw Material Forecasting Model for upcoming regulatory changes for raw materials, those can have impact for the business, by monitoring regulatory changes in other regions. Proactively manage likelihood vs. business impact mapping, sharing criticality and regulatory forecasting map with cross functional team to take necessary actions for business readiness proactively.</p>
</li><li><p>Track- monitor and report completion of necessary changes that need to be done due to new regulations in order to prevent any penalties from authority.</p>
</li><li><p>Ensure that ingredients- formulas- labeling- and packaging are in full compliance with the local laws and regulations where the products are sold; and provide training to the organization on relevant regulatory topics.</p>
</li><li><p>Monitor and provide advice/analysis on best practices from the market for the categories we play in &amp; share it consistently with other RA teams across the company.</p>
</li><li><p>Participating in industrial groups regular meetings (Federation of Food &amp; Drink Industry Associations, Amcham Turkey Food &amp; Agriculture Committee, Salkonder) to proactively monitor and manage regulatory changes, analyzing their business impacts and developing advocacy strategies. Leading necessary internal communications with team to initiate compliance actions to prevent or minimize business risks from new laws.</p>
</li><li><p>Build strategic relationships with regulators and legislative bodies (Ministry of Agriculture and Forestry (MinAF), Directorate General for Food and Control (GDFC)) in Turkey by maintaining consistent communication with them to gain insights for upcoming regulatory changes and shape them (front of pack, nutritional labelling, food additives approvals, etc.).</p>
</li><li><p>Connecting to Kraft Heinz global horizon scan team to monitor upcoming regulation changes to identify risk or opportunities for the business.</p>
</li><li><p>Driving cross-functional cooperation to effectively respond to regulatory related questions, challenges and issues raised for local, import and export products. Supporting supply chain and custom agency team regarding product claim and compliance related documents.</p>
</li><li><p>Executing company-wide regulatory strategies, provide technical and strategic guidance, training to cross functional teams.</p>
</li></ul><p><b>Qualifications &amp; Experience</b></p>
<ul><li><p>Bachelor&rsquo;s degree in Food Technology/ Pharmacy or related disciplines. Master degree is an advantage</p>
</li><li><p>Minimum 5-10 years working experience in the field of regulatory affairs (Turkish Food Law, Turkish Food Codex, Codex Alimentarius, EU Regulations) preferably within an international FMCG environment.</p>
</li><li><p>Good understanding of the commercial drivers of F&amp;B industry and an associated ability to provide advice/guidance that takes these into consideration.</p>
</li><li><p>Building regulatory network internally and externally.</p>
</li><li><p>Familiar with Turkey food registration procedures and regulatory aspects.</p>
</li><li><p>Analytical skills and attention to detail with the capability to appropriately define issues, questions, and data</p>
</li><li><p>Skills such as project management, problem solving, ability to present information in easily understood format at internal and external meetings, good time management, negotiation and interpersonal skills</p>
</li><li><p>Ability to think strategically and act proactively for possible regulatory related risk for the business.</p>
</li><li><p>Commitment to continuous improvement in department processes and performance.</p>
</li><li><p>Strong team player, assisting others, having ability to build strong cross functional team network and cooperation.</p>
</li><li><p>Ability to work both independently and as part of a team as required.</p>
</li><li><p>Be able to balance company commercial needs with compliance requirements.</p>
</li><li><p>Excellent written, presentation and verbal communication skills.</p>
</li><li><p>Fluency in English and Turkish</p>
</li></ul><p>This position can be based in either Susurluk factory or İstanbul Headquarter.</p>
<p><b>About Us</b><br>
The Kraft Heinz Company is one of the largest food and beverage companies in the world, with eight $1 billion+ brands and global sales of approximately $25 billion. We&rsquo;re a globally trusted producer of high-quality, great-tasting, and nutritious foods for over 150 years. Our brands are truly global, with products produced and marketed in over 40 countries. These beloved products include condiments and sauces, cheese and dairy, meals, meats, refreshment beverages, coffee, infant and nutrition products, and numerous other grocery products in a portfolio of more than 200 legacy and emerging brands.</p>
<p>No matter the brand, we&rsquo;re united under one vision To sustainably grow by delighting more consumers globally. Bringing this vision to life is our team of 39,000+ food lovers, creative thinkers, and high performers worldwide. Together, we help provide meals to those in need through our global partnership with Rise Against Hunger. We also stand committed to responsible, sustainable practices that extend to every facet of our business, our consumers, and our communities. Every day, we&rsquo;re transforming the food industry with bold thinking and unprecedented results. If you share our passion &ndash; and are ready to create the future, build a legacy, and lead as a global citizen &ndash; there&rsquo;s only one thing to do join our table and let&rsquo;s make life delicious!</p>
<p><b>Our Culture of Ownership, Meritocracy and Collaboration</b></p>
<p>We're not afraid to think differently. Embrace new ideas. Dream big. We empower our people at every level &ndash; from entry-level intern to senior leader &ndash; to own their work. We share a responsibility to think like Owners &ndash; to be mindful of the collective and sustained success of Kraft Heinz &ndash; which we apply to every situation, every day.</p>
<p>As part of Kraft Heinz, you're supported to grow and achieve. You&rsquo;re expected to bring your authentic self to work every day, to lead with humility, and drive outstanding performance at every level &ndash; and you&rsquo;ll be rewarded. You&rsquo;re given opportunities to leave a mark and build a legacy. But you won&rsquo;t do it alone. You&rsquo;re supported by passionate teammates along the way, and our collective, collaborative spirit fuels our incredible progress.</p><br>
<p>We are proud to be a Great Place to Work certified company. Click to view our certificate: https://www.greatplacetowork.com.tr/sertifikasyon/sertifikali-sirketler/kraft-heinz-turkiye/</p>
<p>Employee Candidate Privacy Notice https //www.heinz.eu/turkey-candidate-privacy-policy</p>
<div>Location(s)</div>
<p>Istanbul Branch</p><p><br>
</p><p><b>Kraft Heinz is an Equal Opportunity Employer &ndash; Underrepresented Ethnic Minority Groups/Women/Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity and other protected classes</b><b>.</b></p></div></div></div></div></div></div>

Regulatory Affairs Associate Manager

Perrigo Company plc

<div>
 At Perrigo, we are driven by our mission to
 <em>
  <strong>
   Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All
  </strong>
 </em>
 . We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing
 <strong>
  <em>
   The Best Self-Care for Everyone
  </em>
 </strong>
 , we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more.
 <strong>
  We Are Perrigo
 </strong>
 . We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
 <br/>
 <br/>
 Join us on our One Perrigo journey as we evolve to win in self-care.
 <br/>
 <br/>
 <strong>
  Description Overview
  <br/>
  <br/>
 </strong>
 In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products, and support in making correct and timely new product applications of Perrigo products on the Turkish market. You will support to ensure compliance with the existing legislation for Medicines, Medical Devices, Biocides and Cosmetics. Another key aspect of the role will be supporting in the achievement of the overall Regulatory, Quality &amp; Safety objectives and timely realization of operational activities. In this position you collaborate closely with the Corporate Regulatory and Turkish Commercial colleagues to strive to help the customer the best.
 <br/>
 <br/>
 <strong>
  Scope of the Role
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Support in the management of change by preparing applications and technical files in support of existing commercial product regulatory maintenance;
  </li>
  <li>
   Support in the regulatory activities on new product development (NPD), including artwork approvals, label claims and associated supporting documentation;
  </li>
  <li>
   Develop and approve label specifications (master text and local artwork text) in compliance with SOPs, as well as promotional materials from a regulatory perspective;
  </li>
  <li>
   Maintain regulatory files and data systems in compliance with SOPs;
  </li>
  <li>
   Represent regulatory affairs in project meetings with both Perrigo staff and external contacts;
  </li>
  <li>
   Follow up on changes in (inter)national regulations and legislations, and support in the interpretation, communication and implementation;
  </li>
  <li>
   Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the Turkish and/or European territory;
  </li>
  <li>
   Support in the communication with local regulatory authorities regarding license applications and notice of change.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Experience Required
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   University Degree in a Scientific Subject;
  </li>
  <li>
   Minimum of 2 years work experience within Regulatory Affairs required, within at least one of the following categories Medical Devices, Biocides, Cosmetics and Medicines;
  </li>
  <li>
   Excellent communicator in Turkish and English;
  </li>
  <li>
   Proficient computer skills esp. Microsoft (word, excel, powerpoint); experience with Veeva, TVT, Trackwise is an asset;
  </li>
  <li>
   Eye for detail, punctual, well organized;
  </li>
  <li>
   Being flexible and adaptable to change;
  </li>
  <li>
   Ability to support several concurrent projects/products simultaneously;
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Benefits
  <br/>
  <br/>
 </strong>
 We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
 <br/>
 <br/>
 Find out more about
 <strong>
  Total Rewards
 </strong>
 at Perrigo.
 <br/>
 <br/>
 <strong>
  Hybrid Working Approach
  <br/>
  <br/>
 </strong>
 We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.
 <br/>
 <br/>
 We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more
 <strong>
  here
  <br/>
  <br/>
 </strong>
 <strong>
  Applicants please note:
 </strong>
 To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
 <br/>
 <br/>
 <em>
  We are 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, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo
 </em>
</div>


Regulatory Affairs, Associate Specialist

Perrigo

<p></p><div><p>At Perrigo, we are driven by our mission to <b><i>Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All</i></b>. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing <b><i>The Best Self-Care for Everyone</i></b>, we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more. <b>We Are Perrigo</b>. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.</p><p></p><p><br>
Join us on our One Perrigo journey as we evolve to win in self-care.</p><p></p><div><div><div><h2 class="jobSectionHeader"><b><br>
Description Overview</b></h2></div><div><p>
In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products, and support in making correct and timely new product applications of Perrigo products on the Turkish market. You will support to ensure compliance with the existing legislation for Medicines, Medical Devices, Biocides and Cosmetics. Another key aspect of the role will be supporting in the achievement of the overall Regulatory, Quality &amp; Safety objectives and timely realization of operational activities. In this position you collaborate closely with the Corporate Regulatory and Turkish Commercial colleagues to strive to help the customer the best.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Scope of the Role</b></h2></div><div><ul><li>
Support in the management of change by preparing applications and technical files in support of existing commercial product regulatory maintenance;</li><li>
Support in the regulatory activities on new product development (NPD), including artwork approvals, label claims and associated supporting documentation;</li><li>
Develop and approve label specifications (master text and local artwork text) in compliance with SOPs, as well as promotional materials from a regulatory perspective;</li><li>
Maintain regulatory files and data systems in compliance with SOPs;</li><li>
Represent regulatory affairs in project meetings with both Perrigo staff and external contacts;</li><li>
Follow up on changes in (inter)national regulations and legislations, and support in the interpretation, communication and implementation;</li><li>
Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the Turkish and/or European territory;</li><li>
Support in the communication with local regulatory authorities regarding license applications and notice of change.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Experience Required</b></h2></div><div><ul><li>
University Degree in a Scientific Subject;</li><li>
Minimum of 2 years work experience within Regulatory Affairs required, within at least one of the following categories Medical Devices, Biocides, Cosmetics and Medicines;</li><li>
Excellent communicator in Turkish and English;</li><li>
Proficient computer skills esp. Microsoft (word, excel, powerpoint); experience with Veeva, TVT, Trackwise is an asset;</li><li>
Eye for detail, punctual, well organized;</li><li>
Being flexible and adaptable to change;</li><li>
Ability to support several concurrent projects/products simultaneously;</li></ul></div></div></div><p><b>
Benefits</b><br>
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.</p><p>
Find out more about <b>Total Rewards</b> at Perrigo.</p><p></p><p><b><br>
Hybrid Working Approach</b><br>
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.</p><p></p><p><br>
We are proud to be included in the Forbes list of &quot;America's Best Employers by State 2024&quot;. Find out more <b>here</b></p><p></p><p><b><br>
Applicants please note:</b> To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.</p><p></p><p><i><br>
We are 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, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo</i></p></div>

Viatris

<div>
 <p>
  At VIATRIS&trade;, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
 </p>
 <p>
  <br/>
 </p>
 <p>
  Viatris empowers people worldwide to live healthier at every stage of life.
 </p>
 <p>
  <br/>
 </p>
 <p>
  We do so via:
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   <strong>
    Access
   </strong>
   &ndash; Providing high quality trusted medicines regardless of geography or circumstance.
  </li>
  <li>
   <strong>
    Leadership
   </strong>
   &ndash; Advancing sustainable operations and innovative solutions to improve patient health; and
  </li>
  <li>
   <strong>
    Partnership
   </strong>
   &ndash; Leveraging our collective expertise to connect people to products and services.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  Every day, we rise to the challenge to make a difference and here&rsquo;s how the (Regulatory Affairs Senior Associate) role will make an impact:
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Key responsibilities for this role include:
  </strong>
 </p>
 <ul>
  <li>
   Support the local regulatory team in the development of regulatory strategies to support the registration of new products, line extensions, major variations, and lifecycle management.
  </li>
  <li>
   Develop strong partnerships with in-country and above country teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
  </li>
  <li>
   Responsible for enhancing relationships with key external agencies (Egyptian Drug authority EDA). Manage the EDA interface throughout the development and lifecycle of a product.
  </li>
  <li>
   Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP&rsquo;s and systems are followed.
  </li>
  <li>
   Ensure a submission planning and forecasting tool is utilized to update timelines, when necessary, communicate changes to relevant partners.
  </li>
  <li>
   Capable of authoring some local submission components in relevant databases.
  </li>
  <li>
   Ensure submission packages are reviewed against local CMC requirements for consistency and completeness.
  </li>
  <li>
   Liaise with the manufacturing sites for obtaining supporting documents as needed.
  </li>
  <li>
   Participate in local and regional regulatory initiatives promoting a culture aligned with Viatris values and which supports compliance, innovation and talent development and retention.
  </li>
  <li>
   Maintain compliance with the regulatory systems, processes and procedures.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   The minimum qualifications for this role are:
  </strong>
 </p>
 <ul>
  <li>
   2-3 years of experience in regulatory affairs, preferably in human medicines.
  </li>
  <li>
   Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
  </li>
  <li>
   Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.
  </li>
  <li>
   Demonstrate experience of effective delivery in a matrix environment.
  </li>
  <li>
   Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
  </li>
  <li>
   Knowledge of drug development, regulations, and guidelines.
  </li>
  <li>
   Knowledge and understanding of quality systems and processes.
  </li>
  <li>
   Ability to influence peers in the organization.
  </li>
  <li>
   Team player.
  </li>
  <li>
   Act independently with less supervision.
  </li>
  <li>
   Analytical thinking.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
 </p>
</div>


Regulatory Affairs Senior Associate

<div>Viatris Egypt S.A.E<div></div><div>
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.<br>
<br>
Viatris empowers people worldwide to live healthier at every stage of life.<br>
<br>
We do so via:<br>
<br>
Access &ndash; Providing high quality trusted medicines regardless of geography or circumstance;<br>
Leadership &ndash; Advancing sustainable operations and innovative solutions to improve patient health; and<br>
Partnership &ndash; Leveraging our collective expertise to connect people to products and services.</div><div><br>
Every day, we rise to the challenge to make a difference and here&rsquo;s how the (Regulatory Affairs Senior Associate) role will make an impact:</div><div><br>
Key responsibilities for this role include:</div><ul><li><div>
Support the local regulatory team in the development of regulatory strategies to support the registration of new products, line extensions, major variations, and lifecycle management.</div></li><li><div>
Develop strong partnerships with in-country and above country teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.</div></li><li><div>
Responsible for enhancing relationships with key external agencies (Egyptian Drug authority EDA). Manage the EDA interface throughout the development and lifecycle of a product.</div></li><li><div>
Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP&rsquo;s and systems are followed.</div></li><li><div>
Ensure a submission planning and forecasting tool is utilized to update timelines, when necessary, communicate changes to relevant partners.</div></li><li><div>
Capable of authoring some local submission components in relevant databases.</div></li><li><div>
Ensure submission packages are reviewed against local CMC requirements for consistency and completeness.</div></li><li><div>
Liaise with the manufacturing sites for obtaining supporting documents as needed.</div></li><li><div>
Participate in local and regional regulatory initiatives promoting a culture aligned with Viatris values and which supports compliance, innovation and talent development and retention.</div></li><li><div>
Maintain compliance with the regulatory systems, processes and procedures.</div></li></ul><div></div><div>
The minimum qualifications for this role are:</div><ul><li><div>
2-3 years of experience in regulatory affairs, preferably in human medicines.</div></li><li><div>
Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.</div></li><li><div>
Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.</div></li><li><div>
Demonstrate experience of effective delivery in a matrix environment.</div></li><li><div>
Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.</div></li><li><div>
Knowledge of drug development, regulations, and guidelines.</div></li><li><div>
Knowledge and understanding of quality systems and processes.</div></li><li><div>
Ability to influence peers in the organization.</div></li><li><div>
Team player.</div></li><li><div>
Act independently with less supervision.</div></li><li><div>
Analytical thinking.</div></li></ul><div></div><div>
At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.</div><div></div><div>
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.</div><div></div><div>
Viatris is an Equal Opportunity Employer.</div></div><div></div>

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

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Associate Regulatory Affairs - based in Dubai