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international regulatory affairs manager

administrative affairs manager

Crs Soft

<div>
 
 
 Who we are?
 
 
 
 
 
 
 It&rsquo;s time to turn on bright mode. Let&rsquo;s meet!
 
 
 We are a software company that produces niche technologies with an innovative, dynamic, and added-value understanding to the leading companies in its field, serving in different sectors in Turkey and abroad. For starters, the first thing you should know is that Crs is an umbrella organization. Our e-transformation brand, e-d&uuml;nya, offers digital solutions on a single platform. Our game brand Corvus Jay provides players of all ages and backgrounds with captivating, humorous, and artistic games that transcend the ordinary and deliver unforgettable experiences with its open-minded, humorous, creative, and vibrant world of pop art. We are excited to expand our investment areas and the sectors we are involved in. Our focus is on innovative research, exploring Big Data Processing, AI, machine learning, and game development. As one of the top 500 IT companies in Turkey, we are one of the fastest-growing technology companies selected by Deloitte Turkey for the 6th time in a row. Our route is always the same, the future!
 
 
 
 
 
 
 Job Description
 
 
 
 
 
 
 The Administrative Affairs Manager is responsible for overseeing office operations, managing administrative tasks, and ensuring the smooth execution of organizational processes. This role includes handling office expenses, coordinating interdepartmental administrative needs, and maintaining operational efficiency. It also includes workspace organization processes when necessary, ensuring that office expansions or layout changes are carried out smoothly and efficiently. Success in this role requires excellent organizational skills, multitasking abilities, and the ability to manage multiple priorities effectively.
 
 
 
 
 
 
 
 
 
 Experience &amp; Skills
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Industrial Engineering, Business Administration, Economics, Administrative Sciences, or a related field
 </li>
 <li>
 Minimum 5 years of experience in administrative affairs, office management, or operations, with at least 2 years in a managerial role
 </li>
 <li>
 Proven ability to lead and develop teams, fostering a high-performance culture
 </li>
 <li>
 Strong strategic thinking, organizational, and multitasking skills
 </li>
 <li>
 Excellent time management, problem-solving abilities, and attention to detail
 </li>
 <li>
 Strong understanding of office infrastructure, facility, and vendor management
 </li>
 <li>
 Experience in relocation and move coordination processes is a plus
 </li>
 <li>
 Ability to communicate effectively at all levels of the organization
 </li>
 <li>
 High proficiency in MS Office tools
 </li>
 <li>
 Fluency in English and Turkish, with strong written and verbal communication skills
 </li>
 </ul>
 
 
 
 
 
 
 
 
 Responsibilities
 
 
 
 
 
 <ul>
 <li>
 Lead and manage the administrative affairs team, setting clear goals and ensuring high performance
 </li>
 <li>
 Oversee and optimize office operations, document organization, filing, and data management processes
 </li>
 <li>
 Manage office expenses and ensure cost-effective administrative solutions
 </li>
 <li>
 Supervise facility management, including maintenance, repairs, and office stock management
 </li>
 <li>
 Coordinate and execute office relocations, move planning, and space organization projects when necessary, ensuring minimal disruption and smooth transitions
 </li>
 <li>
 Ensure workplace compliance with health, safety, and regulatory standards
 </li>
 <li>
 Implement best practices for operational efficiency, facilitating interdepartmental communication and ensuring a well-organized, functional, and productive office environment
 </li>
 <li>
 Oversee office renovations, space planning, and workplace experience to support business growth
 </li>
 <li>
 Develop and implement structured strategies to enhance employee experience, ensuring in-office and off-site engagement initiatives align with company culture while fostering a strategic, well-organized, and engaging workplace
 </li>
 </ul>
 
 
 
 
 
 
 
 
 Perks &amp; Benefits
 
 
 
 
 
 <ul>
 <li>
 Buffet breakfast in the office every morning
 </li>
 <li>
 Comprehensive private health insurance package
 </li>
 <li>
 Meal card &amp; commute compensation,
 </li>
 <li>
 Lots of events and celebrations (check out @crssoft on Instagram)
 </li>
 <li>
 Education fund to support learning and development opportunities
 </li>
 <li>
 Paid birthday off to spend time with your loved ones
 </li>
 <li>
 A gift book on your birthday
 </li>
 <li>
 All the technical equipment and licenses you need
 </li>
 <li>
 Interviews and Q&amp;A sessions with experts
 </li>
 <li>
 Marriage leave (5 days)
 </li>
 <li>
 No dress code!
 </li>
 </ul>
 
 
 
 
 
 Join Us
 
 
 
 
 
 
 Are you passionate about what you are doing or do you have the craziest ideas? If you have an urge to learn and develop more, then you are welcome at Crs. We work with passion and get inspired by each other. You will always find encouragement to do your best, to join various events, to learn new things, and to have fun.
 
</div>

Administrative Affairs Manager

Sabanci University

<div>
 
 Sabanc&inodot; University Student Resources unit is seeking a
 
 Student Resources Assistant Specialist
 
 with the following qualifications:
 
 
 The place of work is the Sabanc&inodot; University Campus in Tuzla.
 
 <ul>
 <li>
 University graduate (preferably from a program taught in English),
 </li>
 <li>
 Excellent spoken and written Turkish and English skills,
 </li>
 <li>
 Proficient in Microsoft Office applications,
 </li>
 <li>
 At least two years of experience in similar positions (preferably in student affairs, administrative affairs, or international office processes at universities),
 </li>
 <li>
 Willingness to take responsibility in critical work processes,
 </li>
 <li>
 Analytical thinking and problem-solving skills,
 </li>
 <li>
 Proficiency in data analysis and reporting,
 </li>
 <li>
 Work carefully and meticulously on tasks that require attention to detail and follow-up,
 </li>
 <li>
 Possess planning, organization, and coordination skills,
 </li>
 <li>
 Be a team player,
 </li>
 <li>
 Possess effective communication skills,
 </li>
 <li>
 Be able to adapt to flexible working hours when necessary,
 </li>
 <li>
 Completion of military service
 </li>
 </ul>
 
 
 
 
 Job Description:
 
 
 In the Sabanc&inodot; University Student Resources Unit, in processes related to academic and administrative procedures for International Undergraduate, Exchange, YKS-Placed Undergraduate, and Foundation Development Year students;
 
 <ul>
 <li>
 Conducting academic and administrative procedures for Foundation Development Year students,
 </li>
 <li>
 Coordinating and conducting the initial registration processes for International Undergraduate, Exchange, and YKS-Placed Undergraduate students at the University,
 </li>
 <li>
 Creating student files and Student Information System records,
 </li>
 <li>
 Keeping records and files related to students' academic status up to date,
 </li>
 <li>
 Providing information and guidance regarding the residence processes of all international students,
 </li>
 <li>
 Participating in Orientation events with all international students and exchange students,
 </li>
 <li>
 Preparing and updating English guidelines, regulations, and procedures,
 </li>
 <li>
 Creating reports, analyses, and statistics that will contribute to decision-making processes,
 </li>
 <li>
 Generating solutions that will improve inter-process operations; playing an active role in process improvement and project work,
 </li>
 <li>
 Ensuring effective coordination with other academic and administrative units,
 </li>
 <li>
 Providing necessary information and guidance to internal and external process stakeholders,
 </li>
 <li>
 Maintaining relations with official institutions and following up on relevant correspondence,
 </li>
 <li>
 Performing other duties as directed by Unit Managers within the scope of Student Resources processes.
 </li>
 </ul>
 
 
 
 
 
 Sabanc&inodot; University is committed to the principle of equal opportunity and equal treatment in education and employment. The University respects all individuals without any discrimination of gender, religion, national and ethnic origin, race, color, physical disability, physical appearance, marital or parental status, sexual orientation, age, or political affiliation in the administration of its educational, admission and employment policies, and its scholarship and university-sponsored programs.
 
 
</div>

Student Resources Assistant Specialist

HUMAN KAPİTAL İNSAN KAYNAKLARI

<div><div>S&uuml;rekli / Tam Zamanl&#305;</div>
<div></div><div>Referans Numaras&#305; : 1981-2041-2025
</div><div>&#304;&#351;e Al&#305;nacak Ki&#351;i Say&#305;s&#305; : 1</div>
<div></div><div>T&uuml;rkiye - &#304;stanbul (Asya)
</div>
<div></div><div>Pozisyon Seviyesi : :Orta D&uuml;zey Y&ouml;netici
</div><div></div><div>&#304;&#351; Alan&#305; : : Ruhsatland&#305;rma
</div><div><div><h4 class="jobSectionHeader">Genel Nitelikler ve &#304;&#351; Tan&#305;m&#305; :</h4>
</div><div>As Human Kapital, on behalf of our corporate client operating in the pharmaceutical industry, we are seeking an International Regulatory Affairs Manager with strong experience in overseas regulatory processes, solid knowledge of global regulations, and proven team management capabilities.
Required Qualifications<ul><li>
Bachelor&rsquo;s degree in Pharmacy, Chemical Engineering, Chemistry, or a related field,</li><li>
Minimum 10 years of experience in the pharmaceutical industry,</li><li>
Prior experience in team management with demonstrated leadership skills,</li><li>
Preferably experienced in preparing overseas regulatory submission dossiers in CTD format,</li><li>
Strong knowledge of global regulations and international health authorities,</li><li>
Familiar with technology transfer processes and R&amp;D (Product Development) activities,</li><li>
Advanced level of English,</li><li>
Proficient in MS Office applications,</li><li>
Strong communication skills and a collaborative team player,</li><li>
For male candidates, completion of military service,</li></ul>
Able to reside in Istanbul Ata&#351;ehir&ndash;Kad&#305;k&ouml;y area or nearby districts.
For Apply; https://humancapital.com.tr/ilan/143/international-regulatory-affairs-manager
Duties and Responsibilities<ul><li>
Monitoring and implementing international regulatory requirements of relevant countries&rsquo; health authorities,</li><li>
Preparing overseas regulatory submission dossiers in compliance with country-specific requirements and managing the submission process,</li><li>
Following up all post-submission processes until product approval and ensuring internal coordination,</li><li>
Establishing effective communication with relevant health authorities,</li><li>
Preparing packaging mock-ups for products to be marketed abroad in accordance with the local language, and managing and tracking design approval processes,</li><li>
Notifying relevant country authorities of variations and changes made to licensed products,</li><li>
Tracking license renewal processes,</li><li>
Working in close cooperation with the Factory Quality Control unit,</li><li>
Contributing to R&amp;D processes,</li><li>
Following up variation approval processes,</li><li>
Managing and supervising the assigned team.</li></ul>
HUMAN KAP&#304;TAL Human Resources and Consulting Services Industry and Trade Limited Company is a private employment agency operating with the authorization of the Turkish Employment Agency dated 20.06.2025 and numbered 228. 
In accordance with Law No. 4904 of the Turkish Employment Agency, no benefit of any kind may be obtained from job seekers. 
Charging job seekers any fee is strictly prohibited.
</div></div><div><div><h4 class="jobSectionHeader">Aday Kriterleri</h4>
</div><div><ul><li>&#304;lan Tarihi : 15.12.2025</li>
<li>E&#287;itim Seviyesi: Lisans Mezun, Y&uuml;ksek Lisans Mezun</li>
<li>Ya&#351;ad&#305;&#287;&#305; &#350;ehir: &#304;stanbul (Asya),
</li><li>Tecr&uuml;be Y&#305;l&#305;: 10-0 Y&#305;l</li>
<li>Yabanc&#305; dil ve seviyesi: &#304;ngilizce - ( Seviye : &#304;leri) 
</li><li>Askerlik Durumu: Yap&#305;ld&#305;, Muaf
</li><li>Firman&#305;n Tercih Etti&#287;i Sekt&ouml;rler : &#304;la&ccedil; &Uuml;retim ve Sat&#305;&#351;&#305;</li></ul></div></div></div>

INTERNATIONAL REGULATORY AFFAIRS MANAGER

Trispera Pharma Solutions

<div>
 
 
 Who We Are
 
 
 
 
 
 
 Trispera is a dynamic medical affairs and pharmaceutical distribution company based in Istanbul, T&uuml;rkiye, with a dedicated focus on rare diseases. As a young and agile start-up, we are committed to ethical business practices and value development-driven collaboration.
 
 
 
 
 
 
 Job Description
 
 
 
 
 
 
 We are seeking a Medical Doctor or Pharmacist with proven experience as a Regional Medical Manager to join our growing team. The successful candidate will play a pivotal role in leading our medical affairs operations in the field of rare diseases.
 
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 
 &bull; Act as the primary point of contact for healthcare professionals (HCPs), ensuring clear, consistent, and effective communication with all external stakeholders. Establish and maintain trusted scientific partnerships through regular, high-quality medical interactions. This is a field-based role, requiring regular on-site interactions with HCPs three days per week.
 
 
 &bull; Provide up-to-date and relevant scientific and product information to key opinion leaders and the broader medical community to foster clinical confidence and understanding.
 
 
 &bull; Map patient journeys, diagnostic practices, and treatment pathways while developing peer-to-peer relationships with relevant HCPs.
 
 
 &bull; Organize and participate in medical meetings, advisory boards, and congress-related engagements.
 
 
 &bull; Develop and implement scientific communication strategies. Support the creation and review of publications in alignment with the company&rsquo;s scientific narrative.
 
 
 &bull; Review medical communication tools, educational resources, and promotional materials for scientific accuracy and regulatory compliance.
 
 
 &bull; Effectively communicate the medical value of the company&rsquo;s products to both internal and external stakeholders.
 
 
 &bull; Identify educational gaps among HCPs and deliver scientific, non-promotional presentations to address those needs.
 
 
 
 
 
 
 Qualifications and Skills
 
 
 
 
 
 
 &bull; MD or PharmB degree,
 
 
 &bull; Minimum 5 years of experience in the pharmaceutical industry (preferred),
 
 
 &bull; Minimum 2 years of experience in the field of rare diseases (preferred),
 
 
 &bull; Background in endocrinology, metabolism, oncology, or hematology (preferred),
 
 
 &bull; Experience in start-up environments or adaptability to fast-paced, agile settings,
 
 
 &bull; Excellent command of both written and spoken English and Turkish,
 
 
 &bull; High level of personal discipline, professionalism, and adherence to ethical standards,
 
 
 &bull; Strong interpersonal and communication skills,
 
 
 &bull; Comfortable working within a matrix management model,
 
 
 &bull; Flexibility with working hours,
 
 
 &bull; Based in Istanbul,
 
 
 &bull; For male candidates: Completion of military service (if applicable).
 
</div>

Regional Medical Manager

AUSTRALIAN CONSULATE GENERAL

<div>The successful applicant will be engaged as a locally engaged staff member by the Australian Consulate-General, Istanbul.
Please be advised that the Australian Consulate-General, Istanbul does not assist with relocation. Any costs associated with taking up the position would be the responsibility of the successful candidate. 

About the Department of Foreign Affairs and Trade
The role of the Department of Foreign Affairs and Trade (DFAT) is to advance the interests of Australia and Australians internationally. This involves strengthening Australia&rsquo;s security, enhancing Australia&rsquo;s prosperity, delivering an effective and high-quality overseas aid program and helping Australian travellers and Australians overseas.
The department provides foreign, trade and development policy advice to the Australian Government. DFAT also works with other Australian government agencies to drive coordination of Australia&rsquo;s pursuit of global, regional and bilateral interests. 

About the position
The Economic Diplomacy Research &amp; Events Officer, under direction from the Head of Post (HOP) and in collaboration with the Economic &amp; Political Team in the Australian Embassy, Ankara, will assist HOP in implementing Australia&rsquo;s economic diplomacy objectives and achieving trade advocacy strategies, including through event organisation and visit management.
The key responsibilities include, but are not limited to:
<ul><li>Under direction from HOP, monitor and report on economic, business and trade developments.</li>
<li>Translate correspondence, media reports, articles, websites and other materials, as required.</li>
<li>Maintain and extend a network of contacts in the community and harness these to pursue Australia&rsquo;s economic and public diplomacy strategic objectives.</li>
<li>Arrange appointments and manage communication with key contacts on behalf of HOP.</li>
<li>Contribute to the organisation of economic diplomacy and representational events, including logistical support, liaison with invitees and ad hoc administrative tasks.</li>
<li>Support post social media platforms, developing content on key economic and public diplomacy and trade issues and objectives, monitoring responses and other metrics and providing advice to enhance engagement.</li>
<li>Assist with the organisation and facilitation of official and high-level visits to T&uuml;rkiye by Australian officials, including arranging meetings and drafting programs.</li>
<li>Provide assistance to the Consular Services and Corporate Services Managers during busy periods, including the provision of consular, passports, and notarial services to Australian citizens and permanent residents in T&uuml;rkiye.</li></ul> 

Qualifications/Experience
<ul><li>Relevant tertiary education with strong research and analytical skills, particularly relating to economics, trade policy and/or business.
</li><li>Knowledge of Turkish economic/commercial and political developments, legislative and administrative framework and business environment is desirable.</li>
<li>Professional-level fluency in and ability to translate between English and Turkish.</li>
<li>Effective communication and interpersonal skills with the ability to develop and maintain good stakeholder relationships.</li>
<li>Strong computer skills required and experience with social media, particularly in a professional setting, is an advantage.</li>
<li>Ability to plan and manage competing priorities, working efficiently as a committed and flexible member of a small but busy team.</li></ul> 

Selection Criteria
Please ensure you provide a response to each of the listed selection criteria below. In your response, you must include relevant high-level examples from your experience that support your claims against the role.
The word limit is strictly 250 words per response to each selection criteria. The panel may not assess incomplete applications or responses which exceed the word limit.
A. Demonstrated ability to research and analyse a wide range of political, economic, and business issues in T&uuml;rkiye and present findings to post management in an appropriate manner.
B. Ability to take initiative, set priorities and organise work effectively and efficiently, completing projects and assignments with limited supervision.
C. Ability to develop and harness a network of contacts in the business community and other stakeholder relationships to support and provide information to post management.
D. Excellent teamworking ability, interpersonal skills and stakeholder management experience liaising with senior level officials and executives.
E. Well-developed written and oral communication skills in English and Turkish with the ability to translate reports and articles.
F. Demonstrated experience with social media and other promotional activity including event management. 

The Human Resources Section based in the Australian High Commission, London is responsible for managing all recruitment processes across the European region. To apply, please use the 'Apply' button below. Please direct any other queries to recruitment.london@dfat.gov.au.
We are committed to providing an inclusive and diverse workplace where all employees are valued. We appreciate the experiences, skills and perspectives of all individuals. We actively encourage applications from people from diverse backgrounds who share our values.
The Australian Consulate-General, Istanbul seeks a research, visits and events officer to assist with economic diplomacy and trade advocacy objectives.</div>

Economic Diplomacy Research and Events Officer – LE4 – DFAT –Istanbul

DEXIS

<div>
 
 Job Description
 
 
 
 Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
 
 
 
 Job Requirements
 
 
 
 
 Reports to Role
 
 : Head of RA Regions &amp; Registrations
 
 
 
 Location
 
 (HQ or Region, Country, Site):
 
 
 Istanbul, Turkey, EH TURKEY SA&Gbreve;LIK &Uuml;R&Uuml;NLER&Idot; VE H&Idot;ZMETLER&Idot; L&Idot;M&Idot;TED &Scedil;&Idot;RKET&Idot;. Fully remote
 
 
 
 
 PURPOSE
 
 
 
 &ndash; in a few sentences, briefly describe the overall purpose of the role, i.e. why the role exists
 
 
 
 The Regulatory Affairs Specialist supports regulatory affairs activities for international product registration by providing regulatory documentation and stakeholder support to ensure the timely regulatory approvals and maintenance of products in compliance with local regulatory requirements.
 
 
 The Regulatory Affairs Specialist is accountable for timely execution of regulatory strategies to support launch activities and maintain compliance status for international product registration.
 
 
 
 
 ACCOUNTABILITIES
 
 
 
 &ndash; describe role accountabilities/responsibilities, i.e. what the role does. Should cover the following:
 
 
 
 The Regulatory Affairs Specialist is accountable for compliance and delivery for all assigned countries and registrations in Regions.
 
 
 
 Regions &amp; Registrations
 
 
 
 <ul>
 <li>
 Contribute to development and execution of regulatory strategies for respective department projects, compliance projects as well as lifecycle management activities.
 </li>
 <li>
 Contribute to execution of International RA support projects for market access to REGIONS and ensure all RA related elements &amp; requirements implemented.
 </li>
 <li>
 Align with local distributors and with local RA, understand requirements, and assists with the deliverables/ files related to preparing ROW submissions; uploads deliverables/ files into repository. Consults with others on these efforts as required.
 </li>
 <li>
 Prepare, order, and maintain oversight of all Free Sales Certificates, Certificates of Foreign Government and Country of Origin certificates requested for international regulatory approvals
 </li>
 <li>
 Prepare core documentation "regulatory submission packages" for new product registrations in international markets
 </li>
 <li>
 Prepare country specific documents for international regulatory approvals including, but not limited to manufacturer statements, Letters of Authorization and Power of Attorney
 </li>
 <li>
 Review submission documents prepared by local RA to be used in country registrations
 </li>
 <li>
 Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes
 </li>
 <li>
 Conduct regulatory release and delisting of products using specialized regulatory software
 </li>
 <li>
 Is aware of procedures and only makes decisions in line with procedure on simple topics
 </li>
 <li>
 Plan out workload to deliver on time, able to make adjustments when required and prioritizing work together with manager
 </li>
 <li>
 Prepare, and follow-up on International regulatory assessments for product changes
 </li>
 <li>
 Closely monitoring together with local country representatives guidelines, regulations, changes in the marketplace and regulator positions for the assigned markets to ensure new requirements are caught, impact assessed and escalated if required
 </li>
 <li>
 Close gaps created due to changed or new local country requirements by initatin projects and/or incorporating into global processes.
 </li>
 <li>
 Support the provision of regulatory guidance to project teams in assigned projects and markets, in terms of requirements and related submission to support optimal timelines and required compliance levels.
 </li>
 <li>
 Support the assembly of documents and the submission to authorities in countries of responsibility
 </li>
 <li>
 Supports the monitoring of the regulatory environment and maintenance of the information resources
 </li>
 <li>
 Support internal and external audits in the audit preparation and audit back office
 </li>
 <li>
 Contributes and participates in the review of change requests to ensure compliance and the potential for regulatory submissions
 </li>
 <li>
 May assist with reviews of promotional materials.
 </li>
 <li>
 Has a yearly training program in place specified by manager.
 </li>
 <li>
 Support the creation and maintenance of regulatory procedures and templates.
 </li>
 <li>
 Can revise or create Technical Files.
 </li>
 <li>
 Support the review of labels and IFUs
 </li>
 <li>
 Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes
 </li>
 <li>
 Tracks and maintains files on current status of licenses, registrations and product information as per agreed formats in the different systems in use by the organization
 </li>
 <li>
 Can collect the regulatory compliance status of main countries, contribute to regulatory status of other regions of devices affected by HHE/Deviation/CAPA/Recall.
 </li>
 <li>
 Provide internal trainings on requirements for area under their responsibility.
 </li>
 <li>
 Knows and understands the EBS philosophy and employs it in daily RA activities and standard work.
 </li>
 <li>
 Able to provide input in terms of activities required to be added to a DM or VPM.
 </li>
 <li>
 Trained on PSP procedures to solve standard problems; analyzes information and standard practices to make judgments.
 
 
 </li>
 </ul>
 
 
 KNOWLEDGE, SKILLS &amp; EXPERIENCE
 
 
 
 &ndash;
 
 
 Functional/technical competencies specific to the role and required to perform the role
 
 
 
 
 Critical Knowledge and Qualifications:
 
 
 (what the role holder must know; including any required general or professional qualifications/education)
 
 
 
 <ul>
 <li>
 A minimum of a Bachelor&rsquo;s degree from accredited college or university is required.
 </li>
 <li>
 Basic knowledge of medical device quality management systems such as 21 CFR Part 820 and ISO 13485.
 </li>
 <li>
 Basic knowledge of international legislation in some countries.
 </li>
 <li>
 Knowledge of main general documents required as FSC &amp; legalization process
 
 
 </li>
 </ul>
 
 Critical Skills/technical know-how:
 
 
 (what the role holder must be able to do)
 
 
 
 <ul>
 <li>
 Fluency in English a must. Further languages is an advantage.
 </li>
 <li>
 Able to communicate effectively with team members, project team members, manager and other stakeholders; this includes: able to listen and grasp key information, able to clearly convey straightforward information, able to read non-verbal communication, such as reading body language and able to give short presentations to RA team on straightforward information
 </li>
 <li>
 Demonstrates and advocates for working together in the spirit of openness, honesty and transparency that encourages engagement, collaboration, respectful interactions and trust.
 </li>
 <li>
 Seeks out diverse ideas, opinions and insights, and applies them in workplace.
 </li>
 <li>
 Works closely with direct team and project teams and starts building up network of colleagues, stakeholders, SMEs and customers.
 </li>
 <li>
 Is aware of procedures and regulations and is able to assess situation on simple topics
 </li>
 <li>
 Creates clarity and direction amid complexity and develops solutions
 </li>
 <li>
 Never compromises on patient safety.
 </li>
 <li>
 Have a positive attitude and 'can do' spirit
 </li>
 <li>
 Ability to be flexible and adaptable. Maintain a professional demeanor under pressure.
 </li>
 <li>
 Demonstrate a commitment to getting the job done right and on time and prioritizing work together with manager.
 </li>
 <li>
 Be able to manage several projects, tasks products and/or countries work load and takes ownership.
 </li>
 <li>
 Have attention to detail to task in hand but also start seeing bigger picture / wider process.
 </li>
 <li>
 Know when to ask questions.
 
 
 </li>
 </ul>
 
 Critical Experience
 
 
 
 <ul>
 <li>
 Minimum 2 years' experience in regulatory affairs or associated field within medical device industry.
 
 
 </li>
 </ul>
 COMPETENCIES &ndash; Essential for the role
 
 
 
 Determine max. 6 competencies, refer to List and Definition of Competencies
 
 
 
 <ul>
 <li>
 Continuous Improvement
 </li>
 <li>
 Planning and Organizing
 </li>
 <li>
 Strategy execution
 </li>
 <li>
 Driving Execution
 </li>
 <li>
 Learning Orientation
 </li>
 <li>
 Actively contribute to successful team
 
 
 </li>
 </ul>
 
 Operating Company
 
 
 
 DEXIS
 
 
 Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
</div>

Regulatory Affairs Specialist

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.
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 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.
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 Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.
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 Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.
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 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.
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 Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.
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 Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.
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 Actively contribute to local and global initiatives that improve regulatory processes.
 
 
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 Professional Experience / Key Skills
 
 
 
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 Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.
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 Degree in Pharmaceutical Sciences or equivalent discipline is preferred.
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 Proven ability to prioritize, conduct, and manage time to meet project deadlines.
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 Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.
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 Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.
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 Strong focus on achievement of goals and continuous improvement
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 Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.
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 Having excellence in multiple project management, good communication and interpersonal skills.
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 Be an analytical thinker, problem solver, proactive, initiative taker, creative personality
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 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.
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 Fluency in spoken and written English.
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 Good decision-making skills are important.
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 Excellent verbal, written, organization skills and interpersonal communication skills required.
 
 
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 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.
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Regulatory Affairs Manager

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