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Job Description We have an exciting career opportunity for a Regulatory Affairs Manager based at Gilead Sciences Istanbul Office.
Regulatory Affairs Manager Turkiye is responsible for managing RA submissions & 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 the country's applicable legislations.
Manage regulatory submissions to local HA submissions including, 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.Manage initial Clinical trials applications, amendments and other clinical trial related submissions & notifications. Works in close contact with Clinical Trials (CT) Hub and Clinical Operations team to complete CT submissions to MOH timely and interacts with cross-functional teams internally and externally to ensure submission package fulfills the MoH requirements on time.Good command of Local Clinical Trial Legislations.Capability and knowledge to assess the Clinical Trial related changes and guide Clinical Operations regarding local requirements.Manages the Clinical Trial related submissions which include initial Clinical Trial submissions, substantial & non-substantial amendments safety notifications, DSURs, and other relevant notifications according to local clinical trial legislations.Ensures the compliance of ongoing clinical trials as per legislation.Responsible for ensuring the compliance of investigational medicinal product (IMP) packaging according to local legislations and providing approval for the IMP labels.Plans the regulatory and clinical trial application timelines & strategy under the leadership of Regulatory Affairs Director (RAD). Close follow up of the assessment processes at MoH and ensures to fulfill their requests in order to achieve the approval of registration applications of the new/established products.Must have excellent knowledge of local & global regulatory & clinical trial requirements, including ICH requirements and regional requirements. Serve as a core Regulatory member in updating and preparing the Company for major changes in regulatory legislation in the country for assigned product(s) or projects.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.Responsible for Regulatory compliance in accordance with local regulations and internal procedures. Solid and proven knowledge of all compliance aspects related to the regulatory affairs function.Responsible for ensuring commercial product packaging and associated information is updated and maintained in accordance with the product license.Acts as project team representative for specified products depending on the complexity of the project.By being an active member of the Task Forces within the company, he/she develops proactive and reactive RA strategies to ensure improvement of processes.Builds and develops a network with regulatory-related stakeholders including decision-makers, influencers, and other interest groups such as KoLs.Must be capable of developing and implementing regulatory & CTA strategy and of managing negotiations with Regulatory Authorities.Actively contributes to local and/or global process improvements which have a significant impact on Gilead. Professional Experience / Key Skills 6+ years of experience in total in Regulatory Affairs & Clinical Trials (CT) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.Degree in Pharmaceutical Sciences or equivalent discipline is preferred.Proven ability to prioritize, conduct, and manage time to meet project deadlines.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.Strong focus on achievement of goals and continuous improvement.Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.Having excellence in multiple project management, good communication, and interpersonal skills.Be an analytical thinker, problem solver, proactive, initiative taker, creative personality.Team player who actively contributes to the team in order to complete tasks, meet goals, or manage projects, actively listens to others, respects ideas, and aims to improve the process.Fluency in spoken and written English.Good decision-making skills are important.Excellent verbal, written, organization skills, and interpersonal communication skills required.
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