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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

Boehringer Ingelheim

<div>OUR COMPANY
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.
Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve. 
THE POSITION
We are looking for an undergraduate student preferably in Medicine, Pharmacy or related fields who is interested in intern position for Medical Affairs. 
Tasks &amp; responsibilities
<ul><li>Providing support to the medical affairs department for administrative processes,
</li><li>Contributing medical team as an active member,
</li><li>Taking an active role for initiatives that are ongoing and will be planned across all TAs in the medical department,
</li><li>Preparing and checking project related forms, documentations and mails, submissions of the documentations to the necessary online systems, following up with approvals and filing all documentations in accordance with the rules,
</li>Assisting and following up communication and coordination within and between the departments. 
<li>
</li></ul>Requirements
<ul><li>Undergraduate (3rd,4th or 5th year) student preferably in Medicine, Pharmacy or related fields,
</li><li>Willingness to Learn and Develop Personal Qualifications,
</li><li>Strong verbal and written communication skills both in Turkish&amp;English,
</li><li>Strong analytical, organization, critical-thinking, problem-solving skills,
</li><li>A strong sense of ownership and accountability,
</li><li>Project Management ability with developed follow-up skills,
</li><li>Ability to work independently and as part of a team,
</li><li>Excellent organizational skills, attention to detail, and the ability to prioritize in a changing environment,
</li><li>Experience in Microsoft Programs like Excel and Power Point is a bonus,
</li>Able to work at least 3 days in a week and continue for 6 months. 
<li>
</li></ul>WHY BOEHRINGER INGELHEIM?
With us, you can grow, collaborate, innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.</div>

Medical Intern

<div>
 
 Our Company
 
 
 
 At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.
 
 
 Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.
 
 
 
 THE POSITION
 
 
 
 We are looking for an undergraduate student preferably in Medicine, Pharmacy or related fields who is interested in intern position for Medical Affairs.
 
 
 
 Tasks &amp; Responsibilities
 
 
 
 <ul>
 <li>
 Providing support to the medical affairs department for administrative processes,
 </li>
 <li>
 Contributing medical team as an active member,
 </li>
 <li>
 Taking an active role for initiatives that are ongoing and will be planned across all TAs in the medical department,
 </li>
 <li>
 Preparing and checking project related forms, documentations and mails, submissions of the documentations to the necessary online systems, following up with approvals and filing all documentations in accordance with the rules,
 </li>
 <li>
 Assisting and following up communication and coordination within and between the departments
 
 
 
 </li>
 </ul>
 
 Requirements
 
 
 
 <ul>
 <li>
 Undergraduate (3rd,4th or 5th year) student preferably in Medicine, Pharmacy or related fields,
 </li>
 <li>
 Willingness to Learn and Develop Personal Qualifications,
 </li>
 <li>
 Strong verbal and written communication skills both in Turkish&amp;English,
 </li>
 <li>
 Strong analytical, organization, critical-thinking, problem-solving skills,
 </li>
 <li>
 A strong sense of ownership and accountability,
 </li>
 <li>
 Project Management ability with developed follow-up skills,
 </li>
 <li>
 Ability to work independently and as part of a team,
 </li>
 <li>
 Excellent organizational skills, attention to detail, and the ability to prioritize in a changing environment,
 </li>
 <li>
 Experience in Microsoft Programs like Excel and Power Point is a bonus,
 </li>
 <li>
 Able to work at least 3 days in a week and continue for 6 months
 
 
 
 </li>
 </ul>
 
 WHY BOEHRINGER INGELHEIM?
 
 
 
 With us, you can grow, collaborate, innovate and improve lives.
 
 
 We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.
 
 
 Our Company
 
 
 
 Why Boehringer Ingelheim?
 
 
 
 With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
 
 
 Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
 
 
 Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
 
 
 Want to learn more? Visit https://www.boehringer-ingelheim.com
</div>

Medical Affairs Intern

Gap Construction

<div>
 
 
 GAP CONSTRUCTION
 
 
 
 
 
 
 &Ccedil;al&inodot;k Holding, one of Turkey's largest industrial organizations, operates in the energy, textile, construction, finance and mining sectors. Established as a subsidiary of &Ccedil;al&inodot;k Holding, Gap Construction has successfully completed numerous projects in Turkey and abroad since its establishment. Gap Construction, which continues its international operations in countries such as Turkmenistan, Iraq, Libya, Saudi Arabia and Qatar, is a company preferred by public authorities in many different projects and has reinforced its credibility with its experience and experience.
 
 
 
 
 
 We are looking for a Human Resources Chief to be assigned in the Istanbul Head Office of Gap Construction.
 
 
 
 
 
 
 Qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree from a reputable university,
 </li>
 <li>
 At least 7 years of HR generalist experience preferably in construction sector,
 </li>
 <li>
 Demonstrable experience with recruitment, performance management, talent management, learning &amp; development, wage management and human resources metrics,
 </li>
 <li>
 Good understanding of labor law, payroll and administrative affairs,
 </li>
 <li>
 Ability to manage and accomplish multiple and complex tasks on a timely manner,
 </li>
 <li>
 Excellent level of analytical and problem solving skills,
 </li>
 <li>
 Ability to communicate effectively with all levels of the organization,
 </li>
 <li>
 Excellent command of written and spoken English,
 </li>
 <li>
 Proficiency in MS Office Applications, SAP is is a plus,
 </li>
 <li>
 No military obligation for male candidates,
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities:
 
 
 
 
 
 <ul>
 <li>
 Be responsible for all HR processes within the company,
 </li>
 <li>
 Provide a broad range of support in employee relations, people engagement, talent management and organizational development,
 </li>
 <li>
 Build and maintain operationally excellent data tracking processes,
 </li>
 <li>
 Support and active contribution to internal communication plan,
 </li>
 <li>
 Maintain HR Data sources, design and run analytic HR reports,
 </li>
 </ul>
 
 
</div>

Human Resources Chief

Envista Holdings

<div>Operating Company: DEXIS 
Location: Istanbul,Istanbul,TR 
Date Posted: November 11, 2025 
Req Number: R5024578</div><div></div>
 <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&#286;LIK &Uuml;R&Uuml;NLER&#304; VE H&#304;ZMETLER&#304; L&#304;M&#304;TED &#350;&#304;RKET&#304;. 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 &quot;regulatory submission packages&quot; 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></ul><ul> <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></ul><ul> <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> <h2 class="jobSectionHeader">COMPETENCIES &ndash; Essential for the role</h2> 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

Token Finansal Teknolojiler

<div>
 
 
 Step into the future of fintech with us!
 
 
 
 
 
 
 We&rsquo;re not just a company; we&rsquo;re a dynamic team of innovators pushing the boundaries of what&rsquo;s possible. We're on the lookout for passionate, forward-thinking Operations Specialist/Senior Specialist to join us on this exciting journey!
 
 Project Assistant &amp; Long Term Intern &ndash; Finance and Financial Affairs
 
 works cross-functionally to help businesses start using Token products as and quickly as possible.
 
 
 
 
 
 
 🔍Who We Are
 
 
 
 
 
 
 At Token Financial Technologies, we lead Turkey&rsquo;s fintech revolution, empowering over 800,000 users and handling nearly 4 million transactions daily. Our flagship solutions, &Ouml;dero and TokenFlex, redefine payment systems and corporate benefits with cutting-edge technology. As part of Ko&ccedil; Holding and partnering with Beko, we&rsquo;re a team of innovators dedicated to driving progress and making a real impact in the financial world.
 
 
 
 
 
 
 ✨ What You&rsquo;ll Be Rocking
 
 
 
 
 
 <ul>
 <li>
 Provide support in tracking and reporting daily financial transactions
 </li>
 <li>
 Contribute to data collection, verification, and comparison efforts during budget preparation processes
 </li>
 <li>
 Assist in updating and organizing financial statements
 </li>
 <li>
 Support expense, cost, and forecast analysis
 </li>
 <li>
 Create data sets using Excel and other reporting tools, and prepare content for presentations
 </li>
 <li>
 Ensure information flow with relevant internal and external stakeholders, compile and organize necessary documents
 </li>
 <li>
 Assist in process improvement and project efforts within the team
 </li>
 </ul>
 
 
 
 
 
 
 
 
 🎯 The Perfect Fit
 
 
 
 
 
 <ul>
 <li>
 Preferably a graduate or senior student from the Faculty of Economics and Administrative Sciences (EAS)
 </li>
 <li>
 Proficient in English at a good level
 </li>
 <li>
 Recent graduate or 1-2 years of work experience
 </li>
 <li>
 Strong analytical skills, detail-oriented, and solution-focused
 </li>
 <li>
 Knowledge of financial analysis, accounting, or cost reporting processes is preferred (e.g., internships)
 </li>
 <li>
 Proficient in MS Excel, capable of supporting reporting and presentation preparation
 </li>
 </ul>
 
 
 
 
 
 🌐 Connect with us
 
 
 
 
 
 
 Web site: https://www.tokeninc.com/
 
 
 Linkedin:https://www.linkedin.com/company/tokeninc/
 
 
 Instagram: https://www.instagram.com/tokenfintech/
 
 
 YouTube:https://www.youtube.com/channel/UCaOpoQtYzio-s3KgGHuSPLA
 
 
 
</div>

Project Assistant & Long Term Intern – Finance and Financial Affairs

Gilead Sciences

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

Regulatory Affairs Manager

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