Associate Director, Regulatory Affairs (Oncology/Hematology & Clinical Trials) – Turkey in Istanbul, Turkey

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Gilead Sciences, Inc.

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – 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’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’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’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

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Job Description

Job Description:

The Associate Director, Regulatory Affairs Turkiye; by being responsible from Oncology/Hemotology portfolio & Clinical Trials applications, 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’s applicable legislations and regulations pertaining to our portfolio to ensure that Gilead medicinal products can be developed, authorized and maintained on the market.

Knowledge & Details:

  • Manage interactions and communication with the local HAs and act as the main point of contact for the local HAs for specific topics under their responsibility.

  • Manage regulatory submissions to local HA submissions inc. but not limited to Pre-MAA related activities (GMP & prioritization applications), marketing Authorisation (MA) applications & variations and other MA maintenance applications, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects & Clinical trials applications, amendments and other clinical trials submissions.

  • Ensure that Gilead fulfils all requirements linked to the Marketing Authorization/ local license as Marketing Authorization Holder or as local representative of the Marketing Authorization Holder.

  • Serve as a core member of the Affiliate Regulatory Team to ensure compliance with local law and regulation and consistency with global procedural documents.

  • Serve as a core member of the Affiliate Regulatory team to manage Regulatory Compliance audits within the affiliate and interact with other departments and support the process as needed.

  • Share with Global/Regional Regulatory Affairs/development teams knowledge on: HA expertise, expectations and requirements. Execute clear goals and objectives in line with the Global/Regional RA strategy and the local Business and Regulatory Heads Vision.

  • Serve as a core member of the Local Regulatory team to help manage negotiations with local HAs with regards to development products e.g. questions on clinical trial applications.

  • Manages potential challenges in registration and changes in health care policies that could impact Gilead and provide key input into strategies to optimize the outcome.

  • Has the capability to maintain up to date knowledge of complex regulatory requirements, contributes to preparation of new local regulatory guidance when applicable, comments on draft regulatory guidance and communicates changes in regulatory information to Global/Regional RA.

  • Serves as a core member of the country brand/launch team or international working group as the representative of regulatory affiliate.

  • 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.

Professional Experience / Key Skills

  • Typically requires a PhD or Masters in Pharmaceutical Sciences or equivalent discipline and minimum 10 years of relevant experience in regulatory affairs/Clinical Trials.

  • Significant Regulatory and Clinical Trials related experience in the Pharmaceutical / Biotech Industry on Oncology/Hematology products including ICH requirements and regional requirements and in understanding current trends in the local affiliate.

  • Proven track record in effectively setting and directing the regulatory or related strategy to enable early patent access for one or more products.

  • Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.

  • Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.

  • Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials and regulatory related activities.

  • Proven effectiveness in making appropriate decisions independently for relatively complex projects or related issues.

  • Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.

  • Excellent verbal, written, organization skills and interpersonal communication skills required.

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’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 log onto your Internal Career Site (!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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