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regulatory affairs consultant

Yordas Group

<div><h3 class="jobSectionHeader"><b>Description</b></h3><div><br>
Yordas Group is a leading international provider of scientific and consultancy services, regulatory advice and training to industry in sustainability, chemicals management and risk assessment. We help ensure companies are compliant and up-to-date with the regulations affecting their supply chains and product portfolios. Yordas is headquartered in the UK, with offices and representation across the globe.</div><div></div><div><br>
<b>
Job title:</b> Regulatory Consultant</div><div>
<b>Grade:</b> Dependent on experience</div><div>
<b>Location:</b> Istanbul, Turkey</div><div>
<b>Salary range:</b> Dependent on experience, full time position</div><div>
<br>
<b>Summary</b></div><div><br>
</div><div>
We are looking for a Regulatory Consultant to support our growing regulatory services under EU-REACH, KKDIK and UK-REACH which entered into force on 1st January 2021.<br>
</div><div>As a member of the regulatory team, you will deliver regulatory and technical services to clients to fulfil compliance requirements for EU-REACH, KKDIK and UK-REACH. You will oversee and coordinate the Only Representative contracts for manufacturers and formulators based outside of these regions, in addition to supporting clients within these regions as necessary.<br>
</div><div>You will deliver and expand our services in a customer facing role and be able to communicate effectively and efficiently with colleagues, clients, international partners and authorities.</div><h3 class="jobSectionHeader"><b><br>
Role and Responsibilities<br>
</b></h3><br>
<ul><li>Provide regulatory and technical advice and support for clients with regard to KKDIK, UK-REACH and EU-REACH regulation</li>
<li>Interpret and understand complex EU, Turkish and UK law and in turn communicate these clearly to clients</li>
<li>Project management of UK-REACH, KKDIK and EU-REACH Registrations and Notifications<br>
Setup and management of Only Representative contracts</li>
<li> Management and expansion of business in strategic regions</li>
<li>Close cooperation with colleagues from all departments within the company to deliver multi-disciplinary services</li>
<li>Implementation of customer-oriented services such as training and webinars</li></ul><br>
<h3 class="jobSectionHeader"><b>
Profile and Qualifications</b></h3><div><br>
For a Regulatory Consultant position, the candidate is expected to have the following skills and qualifications.</div><ul>
<li>Fluent English (spoken and written), additional European languages would be an advantage</li>
<li>Comprehensive knowledge of the EU-REACH and KKDIK regulation and guidance, with strong appreciation of how the UK&rsquo;s exit from the EU impacts on complex supply chains</li>
<li>Good working knowledge of other chemicals legislation is desirable, e.g. CLP, safety data sheets, biocidal products</li>
<li>Demonstrable experience in delivering EU-REACH and KKDIK Registration services, including providing accurate quotations, managing large projects involving internal and external stakeholders, data sharing discussions and contractual negotiations</li>
<li>Demonstrable experience with the IUCLID 6 software for creating Inquiry and Registration dossiers for submission to ECHA (experience with Lead Registration dossiers would also be desirable, though not essential)</li>
<li>Experience using ECHA&rsquo;s REACH-IT platform for submissions</li>
<li>Experience using Turkey&rsquo;s KKS platform for submissions</li>
<li>At least 3 years professional experience in a similar role (Regulatory Consultant role)</li>
<li>University degree in a natural science such as (eco)toxicology, chemistry or environmental sciences</li>
<li>Attention to detail and strong problem-solving skills</li>
<li>Strong communication skills, customer orientation and business acumen</li>
<li>Adaptable and capable of working under pressure towards deadlines</li>
<li> Independent and well organised</li><br>
</ul><br>
<h3 class="jobSectionHeader"><b>Staff Benefits</b></h3><div><br>
Dependent on location, we offer an excellent range of staff benefits, including:</div><ul>
<li>Pension Scheme and Medical Benefits</li>
<li>Generous holidays</li>
<li>Professional Development</li>
<li>Social Culture</li>
<li>Flexible working</li></ul><br>
<h3 class="jobSectionHeader"><b>
About Yordas Group</b></h3><div>
<br>
Yordas Group is a leading provider of scientific, environmental, human health, and global regulatory consulting services. We offer chemical regulatory support, expert scientific services and support on chemicals management and product stewardship, global hazard communication, hazard and risk assessment, analytical and (eco)tox testing.<br>
<br>
Our international client base includes chemical producers, manufacturers, formulators, importers, distributors, retailers as well as trade associations. Yordas serves various industry sectors such as Aerospace, Biocides, Cleaning, Electronics, Lubricants, Nanomaterials, Oil, Gas &amp; Mining, Plastics or Textiles.<br>
<br>
We are an equal opportunity employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, gender reassignment or age.<br>
<br>
Yordas Group embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.</div></div><div></div>

Regulatory Consultant

<div>
 <p>
  <strong>
   Department:
  </strong>
  STAR Regulatory
 </p>
 <p>
  <strong>
   Location:
  </strong>
  Remote Turkey
  <br/>
  <br/>
 </p>
 <strong>
  Description
  <br/>
  <br/>
 </strong>
 Yordas Group is a leading international provider of scientific and consultancy services, regulatory advice and training to industry in sustainability, chemicals management and risk assessment. We help ensure companies are compliant and up-to-date with the regulations affecting their supply chains and product portfolios. Yordas is headquartered in the UK, with offices and representation across the globe.
 <br/>
 <br/>
 <strong>
  Job title:
 </strong>
 Regulatory Consultant
 <br/>
 <strong>
  Grade:
 </strong>
 Dependent on experience
 <br/>
 <strong>
  Location:
 </strong>
 Istanbul, Turkey
 <br/>
 <strong>
  Salary range:
 </strong>
 Dependent on experience, full time position
 <br/>
 <br/>
 <strong>
  Summary
  <br/>
  <br/>
 </strong>
 We are looking for a Regulatory Consultant to support our growing regulatory services under EU-REACH, KKDIK and UK-REACH which entered into force on 1st January 2021.
 <br/>
 <br/>
 As a member of the regulatory team, you will deliver regulatory and technical services to clients to fulfil compliance requirements for EU-REACH, KKDIK and UK-REACH. You will oversee and coordinate the Only Representative contracts for manufacturers and formulators based outside of these regions, in addition to supporting clients within these regions as necessary.
 <br/>
 <br/>
 You will deliver and expand our services in a customer facing role and be able to communicate effectively and efficiently with colleagues, clients, international partners and authorities.
 <br/>
 <br/>
 <strong>
  Role and Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Provide regulatory and technical advice and support for clients with regard to KKDIK, UK-REACH and EU-REACH regulation
  </li>
  <li>
   Interpret and understand complex EU, Turkish and UK law and in turn communicate these clearly to clients
  </li>
  <li>
   Project management of UK-REACH, KKDIK and EU-REACH Registrations and Notifications
   <br/>
   Setup and management of Only Representative contracts
  </li>
  <li>
   Management and expansion of business in strategic regions
  </li>
  <li>
   Close cooperation with colleagues from all departments within the company to deliver multi-disciplinary services
  </li>
  <li>
   Implementation of customer-oriented services such as training and webinars
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Profile and Qualifications
  <br/>
  <br/>
 </strong>
 For a Regulatory Consultant position, the candidate is expected to have the following skills and qualifications.
 <ul>
  <li>
   Fluent English (spoken and written), additional European languages would be an advantage
  </li>
  <li>
   Comprehensive knowledge of the EU-REACH and KKDIK regulation and guidance, with strong appreciation of how the UK&rsquo;s exit from the EU impacts on complex supply chains
  </li>
  <li>
   Good working knowledge of other chemicals legislation is desirable, e.g. CLP, safety data sheets, biocidal products
  </li>
  <li>
   Demonstrable experience in delivering EU-REACH and KKDIK Registration services, including providing accurate quotations, managing large projects involving internal and external stakeholders, data sharing discussions and contractual negotiations
  </li>
  <li>
   Demonstrable experience with the IUCLID 6 software for creating Inquiry and Registration dossiers for submission to ECHA (experience with Lead Registration dossiers would also be desirable, though not essential)
  </li>
  <li>
   Experience using ECHA&rsquo;s REACH-IT platform for submissions
  </li>
  <li>
   Experience using Turkey&rsquo;s KKS platform for submissions
  </li>
  <li>
   At least 3 years professional experience in a similar role (Regulatory Consultant role)
  </li>
  <li>
   University degree in a natural science such as (eco)toxicology, chemistry or environmental sciences
  </li>
  <li>
   Attention to detail and strong problem-solving skills
  </li>
  <li>
   Strong communication skills, customer orientation and business acumen
  </li>
  <li>
   Adaptable and capable of working under pressure towards deadlines
  </li>
  <li>
   Independent and well organised
   <br/>
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Staff Benefits
  <br/>
  <br/>
 </strong>
 Dependent on location, we offer an excellent range of staff benefits, including:
 <ul>
  <li>
   Pension Scheme and Medical Benefits
  </li>
  <li>
   Generous holidays
  </li>
  <li>
   Professional Development
  </li>
  <li>
   Social Culture
  </li>
  <li>
   Flexible working
  </li>
 </ul>
</div>


Kraft Heinz

<div>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 <strong>
  About the Posiion
  <br/>
  <br/>
 </strong>
 Regulatory Affairs Executive 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 Supplier &amp; External Manufacturing Sr Manager - East &amp; dotted-line reporting to Head of Legal T&uuml;rkiye.
 <br/>
 <br/>
 <strong>
  Key Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   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.
  </li>
  <li>
   Check the compliance of the health and nutritional and other claims against the relevant legislation.
  </li>
  <li>
   Support the Marketing team in providing and approving legislation of the products&rsquo; information relating to product functional - health - nutritional claims including ads and online marketing.
  </li>
  <li>
   Provide information and advice on legislation for product formulation- packaging- and labelling issues.
  </li>
  <li>
   Prepare product registration files with claim substantiation docs and follow up till registration is done.
  </li>
  <li>
   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.
  </li>
  <li>
   Support the business with regulatory information relating to products produced and sold in other regions.
  </li>
  <li>
   Work with cross country teams to ensure regulatory compliance of export and import products including filling necessary applications.
  </li>
  <li>
   Horizon scanning possible regulatory related changes within your region. Build and maintain relationships with the relevant authorities to maintain awareness of new food legislation and government guidance.
  </li>
  <li>
   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.
  </li>
  <li>
   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
  </li>
  <li>
   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
  </li>
  <li>
   Build presence in the local trade associations and industry groups as a forum to discuss upcoming or existing regulatory changes; and proactively monitor regulatory activities in our markets to address and influence proposed regulations to preserve the organization&rsquo;s freedom to operate
  </li>
  <li>
   Provide proposals for the amendment of existing or new regulations to support the interests of the organization
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications &amp; Experience
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bacherlor&rsquo;s degree in Food Technology/ Pharmacy or related disciplines. Master degree is an advantage
  </li>
  <li>
   Minimum 3 years&rsquo; working experience in the field of regulatory affairs, preferably within an international environment.
  </li>
  <li>
   Familiar with Turkey food registration procedures and regulatory aspects.
  </li>
  <li>
   Good understanding of the commercial drivers of F&amp;B industry and an associated ability to provide advice/guidance that takes these into consideration
  </li>
  <li>
   Analytical skills and attention to detail with the capability to appropriately define issues, questions, and data
  </li>
  <li>
   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
  </li>
  <li>
   Ability to work both independently and as part of a team as required
  </li>
  <li>
   Be able to balance company commercial needs with compliance requirements
  </li>
  <li>
   Ability to think strategically and innovatively for resolution of regulatory issues
  </li>
  <li>
   Commitment to continued improvement in department processes and performance
  </li>
  <li>
   Strong team player, assisting others with workload peaks and the management of challenging situations
  </li>
  <li>
   Fluency in English and Turkish
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 This position can be based in either Susurlul factory or &Idot;stanbul Headquarter.
 <br/>
 <br/>
 <strong>
  About Us
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 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!
 <br/>
 <br/>
 <strong>
  Our Culture of Ownership, Meritocracy and Collaboration
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 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/
 <br/>
 <br/>
 Employee Candidate Privacy Notice https //www.heinz.eu/turkey-candidate-privacy-policy
 <br/>
 <br/>
 Location(s)
 <br/>
 <br/>
 Istanbul Branch
 <br/>
 <br/>
 <strong>
  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
 </strong>
 <strong>
  .
 </strong>
</div>


Regulatory Affairs Executive

Reckitt

<div>
 We are Reckitt
 <br/>
 <br/>
 Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.
 <br/>
 <br/>
 Research &amp; Development
 <br/>
 <br/>
 In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
 <br/>
 <br/>
 We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
 <br/>
 <br/>
 The size of our organisation means you'll have the opportunity to learn and work in different functions within R&amp;D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
 <br/>
 <br/>
 <strong>
  About The Role
  <br/>
  <br/>
 </strong>
 As a Regulatory Associate, you&rsquo;ll be at the forefront of our innovation and compliance efforts. You&rsquo;ll jumpstart your career in a role that provides a blend of strategic thinking and hands-on experience within a dynamic, collaborative environment. If you have a passion for science and a drive to ensure the safety and efficacy of consumer products, your skills could be a perfect match for us. Together, we will work to navigate the exciting regulatory landscape, ensuring our diverse product range not only meets but exceeds the highest standards.
 <br/>
 <br/>
 Your responsibilities
 <br/>
 <br/>
 <ul>
  <li>
   Support the development and rollout of new products by navigating regulatory requirements and maintaining compliance.
  </li>
  <li>
   Engage with regulatory authorities, staying abreast of the changing landscape and expertly managing product compliance.
  </li>
  <li>
   Contribute to the team by formatting and compiling regulatory submission documents under guidance.
  </li>
  <li>
   Access and understand regulations and guidelines, applying them effectively to projects, as directed.
  </li>
  <li>
   Communicate and interact with cross-functional teams, playing a pivotal role in project meetings to understand objectives.
   <br/>
   <br/>
  </li>
 </ul>
 The experience we're looking for
 <br/>
 <br/>
 <ul>
  <li>
   0-3 years of experience within the regulatory field, ideally supported by a BSc or MSc in a scientific discipline such as chemistry and chemistry engineering.
  </li>
  <li>
   Ability to work under pressure while ensuring task execution and adherence to deadlines.
  </li>
  <li>
   Developing business acumen and commercial awareness, with a view to understanding product lifecycle management.
  </li>
  <li>
   Capacity for insight into consumer needs and expectations.
  </li>
  <li>
   Eagerness to collaborate, build partnerships, and continuously innovate.
   <br/>
   <br/>
  </li>
 </ul>
 The skills for success
 <br/>
 <br/>
 Task Execution Under Pressure, Business Acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, R&amp;D, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes.
 <br/>
 <br/>
 What we offer
 <br/>
 <br/>
 With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
 <br/>
 <br/>
 Equality
 <br/>
 <br/>
 We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
</div>


Regulatory Associate (Hygiene) / Fixed Term Contract

Transmed Holding Limited

<div>Overview:
<div>
Transmed Turkiye is a full-service distributor company across 13 countries, managing distribution, sales, and marketing for 35 leading brands. We strongly believe in putting people first &ndash; our customers, our teams, our partners.</div><div></div><div><br>
We are seeking a <b>Regulatory Affairs Officer</b>.</div>
Responsibilities:<div></div><div><b><br>
JOB DESCRIPTION:</b></div><br>
<div></div><ul><li>
Conducting preliminary evaluations of imported and planned-to-be-imported products for compliance with local and international regulations,</li><li>
Managing the regulatory approval processes for food, food supplements, cosmetics, cleaning products, and animal-origin products,</li><li>
Following up on official correspondence with the Ministry of Agriculture and Forestry, Ministry of Health, and Ministry of Environment, Urbanization and Climate Change,</li><li>
Registering and archiving products in the relevant ministry systems (e.g., GGBS, HBS),</li><li>
Continuously monitoring regulatory updates and inform relevant departments in a timely manner,</li><li>
Managing the follow-up and renewal processes of supplier quality certificates,</li><li>
Collaborating with Demand Planning, Category, and Business Development teams during new product launches,</li><li>
Working in cooperation with consultancy firms during permit and approval processes.</li></ul>
Qualifications:<div></div><div><b><br>
*** This position does not offer a hybrid / remote option.</b></div><br>
<div></div><ul><li>
Bachelor&rsquo;s Degree in Food Engineering or in a related field,</li><li>
Minimum 2 years of experience in regulatory affairs for food, non-food, and cosmetic products,</li><li>
Preferably experienced in regulatory processes at consultancy or import companies,</li><li>
Advanced MS Office skills,</li><li>
Proficient in English,</li><li>
Proactive in following regulations, detail and result-oriented,</li><li>
Strong communication skills and a good team player,</li><li>
Completed military service for male candidates.</li></ul></div>

Regulatory Affairs Officer

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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 <strong>
  Knowledge &amp; Details
  <br/>
  <br/>
 </strong>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Professional Experience / Key Skills
  <br/>
  <br/>
 </strong>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 Equal Employment Opportunity (EEO)
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <strong>
  For Current Gilead Employees And Contractors
  <br/>
  <br/>
 </strong>
 Please apply via the Internal Career Opportunities portal in Workday.
</div>


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