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administrative affairs specialist

medical affairs intern

Boehringer Ingelheim

<div>
 <strong>
  Our Company
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <strong>
  THE POSITION
  <br/>
  <br/>
 </strong>
 We are looking for an undergraduate student preferably in Medicine, Pharmacy or related fields who is interested in intern position for Medical Affairs.
 <br/>
 <br/>
 <strong>
  Tasks &amp; Responsibilities
  <br/>
  <br/>
 </strong>
 <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
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Requirements
  <br/>
  <br/>
 </strong>
 <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
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  WHY BOEHRINGER INGELHEIM?
  <br/>
  <br/>
 </strong>
 With us, you can grow, collaborate, innovate and improve lives.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 Our Company
 <br/>
 <br/>
 <strong>
  Why Boehringer Ingelheim?
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 Want to learn more? Visit https://www.boehringer-ingelheim.com
</div>


Medical Affairs Intern

<div><p><b>OUR COMPANY
</b></p><p>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.
</p><p>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.<br>
</p><p></p><p><b>THE POSITION
</b></p><p>We are looking for an undergraduate student preferably in Medicine, Pharmacy or related fields who is interested in intern position for Medical Affairs.<br>
</p><p></p><p><b>Tasks &amp; responsibilities
</b></p><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.<br>
<li>
</li></ul><p></p><p><b>Requirements
</b></p><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.<br>
<li>
</li></ul><p></p><p><b>WHY BOEHRINGER INGELHEIM?
</b></p><p>With us, you can grow, collaborate, innovate and improve lives.
</p><p>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.</p></div><p></p>

Medical Intern

<div><p>Job Description</p><p></p><p>
The Medical Affairs Manager holds primary responsibility within the country for the development and execution of the Medical Affairs strategic plans and, is expected to spend at least 50% of their time in external engagements. Key responsibilities include cross-functional strategy collaboration and execution, building trust with the medical/scientific community, facilitating peer-to-peer medical and scientific exchange, and providing asset issue resolution support.</p><p></p><p><b>
Job Description</b></p><ul><li><p>
Translates Global Medical Goals and Strategies into tactics and solutions that support optimal scientific exchange aimed at helping improve patient outcomes and enhancing access in collaboration with colleagues,</p></li><li><p>
Facilitates the delivery of data generation activities (phases I-IV), including the identification of suitable research projects, research centers, investigators, and innovative methods to generate data,</p></li><li><p>
Provides non-promotional, balanced, and reliable scientific information following company standards and local regulations,</p></li><li><p>
Communicates scientific and business needs appropriately and effectively across internal and external stakeholders, Leads country advisory boards and expert input forums,</p></li><li><p>
Provides access support as needed (e.g., health technology assessment, pre-license patient access, reimbursement dossier).</p></li><li><p>
Evaluate and interpret medical literature, abstract and writing medical information in various formats</p></li><li><p>
Ability to review/understand complex scientific and medical data from clinical trials (and summarize content in both written and verbal forms)</p></li></ul><p></p><p><b>
Qualifications</b></p><ul><li><p>
Medical Degree or higher (e.g., PhD),</p></li><li><p>
A minimum of 2-3 years of medical affairs experience in relevant disease area</p></li><li><p>
Experience with local pharmaceutical industry guidelines, regulatory/reimbursement framework, and clinical research guidelines,</p></li><li><p>
Excellent command of both written and spoken English,</p></li><li><p>
Ability to effectively collaborate across functions in a matrix environment.</p></li></ul><p></p><p><b>
Required Skills:
</b></p>Advisory Board Development, Clinical Trials, Data Analysis, Medical Literature Review, Pharmaceutical Guidelines, Professional Presentation, Regulatory Frameworks, Scientific Communications, Stakeholder Engagement, Strategic Thinking<p></p><p><b>
Preferred Skills:
</b></p><p></p><p>Current Employees apply HERE</p><p></p><p>
Current Contingent Workers apply HERE</p><p></p><p><b>
Search Firm Representatives Please Read Carefully</b><br>
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.</p><p></p><p><b>
Employee Status:
</b></p>Regular<p></p><p><b>
Relocation:</b></p><p></p><p><b>
VISA Sponsorship:</b></p><p></p><p><b>
Travel Requirements:</b></p><p></p><p><b>
Flexible Work Arrangements:</b></p>
Hybrid<p></p><p><b>
Shift:</b></p><p></p><p><b>
Valid Driving License:</b></p><p></p><p><b>
Hazardous Material(s):</b></p><p></p><p><b>
Job Posting End Date:</b></p>
11/28/2025<ul><li><b>A job posting is effective until 11:59:59PM on the day </b><b>BEFORE</b><b> the listed job posting end date. Please ensure you apply to a job posting no later than the day </b><b>BEFORE</b><b> the job posting end date.<br>
</b></li></ul><br>
<p><b>Requisition ID:</b>R374126</p></div>

Medical Affairs Manager, Cardiovascular

Manpower Türkiye

<div>
 <p>
  We are looking for a
  <strong>
   "Regulatory Affairs Assistant to Specialist"
  </strong>
  on behalf of a client to whom we provide consultancy services, operating in the hearing aids and medical equipment industry.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Definition
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  &bull; Support the preparation, review, and submission of regulatory documentation in compliance with local and international requirements.
 </p>
 <p>
  &bull; Assist in maintaining regulatory files and product registration databases.
 </p>
 <p>
  &bull; Support audit and inspection preparation activities as needed.
 </p>
 <p>
  &bull; Collaborate effectively with different business teams to ensure smooth regulatory processes and timely submissions.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Qualifications
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  &bull; Bachelor&rsquo;s degree in Pharmacy, Biomedical Engineering, Chemistry, Biology, or a related life sciences field.
 </p>
 <p>
  &bull; Up to 1 year of professional experience in Regulatory Affairs or related areas in medical device sector.
 </p>
 <p>
  &bull; Strong communication and coordination skills, with the ability to work effectively across departments.
 </p>
 <p>
  &bull; Excellent attention to detail and organizational skills.
 </p>
 <p>
  &bull; Fluency in English (both written and spoken) is required.
 </p>
 <p>
  &bull; Proficiency in MS Office applications.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <em>
   Please note that only the candidates that fulfill these requirements will be considered and shortlisted candidates will be contacted. LinkedIN &uuml;zerinden elektronik olarak iletece&gbreve;iniz ki&scedil;isel bilgileriniz, 6698 say&inodot;l&inodot; Ki&scedil;isel Verilerin Korunmas&inodot; Kanunu ve ilgili mevzuat &ccedil;er&ccedil;evesinde, Experis T&uuml;rkiye (Manpower Group T&uuml;rkiye) taraf&inodot;ndan yaln&inodot;zca &Scedil;irketimizden talep etti&gbreve;iniz hizmetlerin sunulabilmesi ve bu hizmetlerin s&uuml;reklili&gbreve;inin sa&gbreve;lanmas&inodot; ama&ccedil;lar&inodot;yla saklanabilecek, i&scedil;lenebilecek ve verilen servisin gerektirdi&gbreve;i hallerde yurti&ccedil;inde ve yurtd&inodot;&scedil;&inodot;nda yerle&scedil;ik 3. ki&scedil;ilerle payla&scedil;&inodot;labilecek olup, ki&scedil;isel verileriniz hi&ccedil;bir &scedil;ekilde hukuka ve d&uuml;r&uuml;stl&uuml;k kural&inodot;na ayk&inodot;r&inodot; &scedil;ekilde ba&scedil;kalar&inodot; ile payla&scedil;&inodot;lmayacak ve i&scedil;leme sebebi d&inodot;&scedil;&inodot;nda ba&scedil;ka ama&ccedil;larla kullan&inodot;lmayacakt&inodot;r. Ki&scedil;isel verileriniz yaln&inodot;zca i&scedil;leme amac&inodot;n&inodot;n gerekli k&inodot;ld&inodot;&gbreve;&inodot; s&uuml;re boyunca saklanacak olup talebiniz &uuml;zerine silinecek veya imha edilecektir. Detayl&inodot; bilgiye https://www.experis.com.tr/site/kisisel-verilerin-korunmasi/39 linkinden ula&scedil;abilirsiniz. Bu i&scedil;e ba&scedil;vurarak, &ouml;zge&ccedil;mi&scedil;inizin veritaban&inodot;m&inodot;zda yer almas&inodot;n&inodot; kabul etmi&scedil; oldu&gbreve;unuzu bildirmek isteriz.
  </em>
 </p>
 <p>
 </p>
</div>


Regulatory Affairs Assistant to Specialist

Eli Lilly

<div><p>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.</p><p></p><div><b>
JOB RESPONSIBILITIES</b></div><div></div><div><div><div><div><div><div><div><div><div><p><b>
Brand Team Support</b></p><ul><li><p>
Serve as a key medical point of contact for the brand team.</p></li><li><p>
Contribute clinical, scientific, and strategic input to support the cross functional team.</p></li><li><p>
Medical launch support</p></li><li><p>
By offering scientific and creative input, contribute to the development (local materials) and/or review (global/regional materials) of promotional materials for the brand teams.</p></li><li><p>
Effectively communicate and transfer knowledge of the therapeutic available solutions environment, the clinical landscape and relevant medical and scientific information</p></li><li><p>
Support the medical training needs of internal business partners such as sales and marketing.</p></li><li><p>
Support the planning &amp; implementation of symposia, advisory boards, scientific exchange, and educational meetings/events with HCP&rsquo;s.</p></li></ul><p></p><p><b>
Customer Support &amp; Experience</b></p><ul><li><p>
Respond to external customer questions and needs, including escalations by Med Info &amp; sales in accordance with company-wide requirements for responding to unsolicited requests for information.</p></li><li><p>
The local coordination of activities and engagement of Thought Leaders</p></li><li><p>
Speaker training</p></li><li><p>
Develop and maintain collaborations and relationships with relevant professional societies.</p></li><li><p>
Deliver scientific, educational, and promotional presentations internally and to customers.</p></li><li><p>
Collaborate cross-functionally to drive improvement in customer engagement through Digital innovation.</p></li><li><p>
Oversee the collation and analysis of customer information to drive understanding and insights.</p></li></ul><p></p><p><b>
Scientific Expertise and Medical Affairs Delivery</b></p><ul><li><p>
Develop and/or contribute to the affiliate / therapeutic area medical plan and strategies.</p></li><li><p>
Support data analysis and the development of slide sets and publications (abstracts, posters, manuscripts)</p></li><li><p>
Keep up to date with medical and other scientific developments relevant to the product or portfolio.</p></li><li><p>
Be aware of current trends, issues and projections for clinical practice and access.</p></li><li><p>
Partner with other existing medical affairs roles to achieve a seamless medical team aimed at delivering exceptional customer experiences.</p></li><li><p>
May serve as the affiliate medical/scientific leader including research and regulatory deliverables.</p></li></ul><p></p><p><b>
QUALIFICATIONS</b></p><ul><li><p>
Advanced degree (MD) in health sciences min. 3 years of relevant clinical, therapeutic experience or relevant scientific industry experience</p></li><li><p>
Cardiometabolic Health experience preferred</p></li><li><p>
Good planning and organization skills</p></li><li><p>
Strong communication skills</p></li><li><p>
Ability to effectively partner across multiple functions.</p></li><li><p>
Advanced interpersonal, project management and presentation skills</p></li><li><p>
Fluent in English (both verbal and written)</p></li><li><p>
Ability to &lsquo;translate&rsquo; scientific data into meaningful, clear, and compliant content for customer communications and engagement.</p></li><li><p>
Commercial/business acumen</p></li><li><p>
Location: Based in Istanbul</p></li></ul></div></div></div></div></div></div></div></div></div><p></p><p>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.</p><p></p><p>
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.</p><p></p><p>
#WeAreLilly</p></div>

Director - Medical, CMH, Türkiye

Gilead Sciences

<div><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.</div><div><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.</div><div><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>
Job Description</div><div><br>
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.</div><div></div><div>
Knowledge &amp; Details:</div><ul><li><div>
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.</div></li><li><div>
Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.</div></li><li><div>
Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.</div></li><li><div>
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.</div></li><li><div>
Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.</div></li><li><div>
Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.</div></li><li><div>
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.</div></li><li><div>
Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.</div></li><li><div>
Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.</div></li><li><div>
Actively contribute to local and global initiatives that improve regulatory processes.</div></li></ul><div></div><div>
Professional Experience / Key Skills</div><ul><li><div>
Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.</div></li><li><div>
Degree in Pharmaceutical Sciences or equivalent discipline is preferred.</div></li></ul><ul><li><div>
Proven ability to prioritize, conduct, and manage time to meet project deadlines.</div></li><li><div>
Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.</div></li><li><div>
Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.</div></li><li><div>
Strong focus on achievement of goals and continuous improvement</div></li><li><div>
Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.</div></li><li><div>
Having excellence in multiple project management, good communication and interpersonal skills.</div></li><li><div>
Be an analytical thinker, problem solver, proactive, initiative taker, creative personality</div></li><li><div>
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.</div></li><li><div>
Fluency in spoken and written English.</div></li><li><div>
Good decision-making skills are important.</div></li><li><div>
Excellent verbal, written, organization skills and interpersonal communication skills required.</div></li></ul><div></div><div><br>
Equal Employment Opportunity (EEO)</div><div>
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively &quot;Gilead&quot; or the &quot;Company&quot;) 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.</div><div></div><div><br>
For Current Gilead Employees and Contractors:</div><div>
Please apply via the Internal Career Opportunities portal in Workday.</div></div>

Regulatory Affairs Manager

<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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