Regulatory Affairs Manager at GILEAD REMNANT PTE LTD

Istanbul, Istanbul, Turkey -

Full Time

Start Date

Immediate

Expiry Date

14 Mar, 26

Salary

0.0

Posted On

14 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Clinical Trials, Pharmaceutical Industry, Project Management, Communication Skills, Analytical Thinking, Problem Solving, Negotiation Skills, Leadership Skills, Team Player, Fluency in English, Time Management, Continuous Improvement, Solution-Oriented, Interpersonal Skills, Creative Thinking

Industry

Biotechnology Research

Description

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. 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 & 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’s applicable legislations. Knowledge & Details: 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. Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes. Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses. 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. Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals. Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director. 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. Build and maintain networks with regulatory stakeholders, including decision-makers and influencers. Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities. Actively contribute to local and global initiatives that improve regulatory processes. Professional Experience / Key Skills Solid experience in total in Regulatory Affairs & Clinical Trials (if possible) 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 listen others, respect ideas and aim 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. 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 apply via the Internal Career Opportunities portal in Workday. 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.

Responsibilities

The Regulatory Affairs Manager is responsible for managing regulatory submissions and supporting clinical trial applications while interacting with local regulatory authorities. They ensure compliance with local legislation and maintain strong relationships with various functional areas within the organization.