Regulatory Affairs Associate Director Cell Therapy Program Jobs in Dubai – UAE at Gilead Sciences, Inc.
Title: Regulatory Affairs Associate Director Cell Therapy Program
Company: Gilead Sciences, Inc.
Location: Dubai – UAE
Type: Remote/Work from Home
Category: Pharmaceutical, Science
Regulatory Affairs Associate Director Cell Therapy Program Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For Current Kite Pharma Employees and Contractors:
We are looking for a unique individual who is passionate about advancing therapeutics and with creative problem solving skills to seamlessly meet the business needs while maintaining regulatory compliance. This is an exciting opportunity for an Associate Director to join the Regulatory Affairs team built on a strong sense of teamwork and excellence. This position is based in Dubai reporting to the Director of Regulatory Affairs.
The successful candidate will lead the regulatory strategy and execution of the Cell Therapy program including NDA and life cycle submissions in the Kingdom of Saudi Arabia. The role involves close cross-functional collaboration with a diverse number of stakeholders both internally and externally to: Define, develop and lead regulatory strategies to maximize regulatory success towards achievement of the program objectives, Provide strategic and tactical advice to achieve timely and efficient regulatory submissions and maintenance, while ensuring compliance with applicable regulatory requirements, Engage with the broader Regulatory community within Kite/Gilead, Contribute to cross-functional initiatives and represent the regulatory function at the ICR International project team meetings Primary
ResponsibilitiesAccountable for collaborating cross-functionally to ensure the development and execution of robust regulatory strategies whilst ensuring regulatory compliance Ensure project team colleagues, line management, and key stakeholders are appraised of developments that may impact regulatory success, exercising sound judgement and communicating in a timely manner Responsible for anticipating and quantifying risks and proposing solutions with the probability of success. Accountable for regulatory submissions and approvals, in collaboration with internal and external stakeholders Serve as the direct point of contact with health authorities, and lead and manage health authority interactions/meetings Be accountable for establishing strong working relationships with regulatory central team, other functions as required and the distributor to ensure global regulatory submissions are provided to local representative in compliance with local regulations and to maintain compliance Participate in or lead departmental and cross-functional taskforces and initiatives Actively monitor and anticipate trends that impact both the regulatory and access environment and adapt regulatory strategies in a timely manner Facilitate manufacturing sites registration in line with national requirements Point contact at the cross functional and International project team meetings Be responsible for demonstrating Gilead leadership commitments Labelling and Packaging .
Provide regulatory support to development of local product labelling, in accordance with local requirements. Ensure Regulatory Labelling compliance and submission of safety updates in line with Health Authorities requirements & internal compliance deadlines. Responsible for ensuring product packaging and associated information is updated and maintained in ac…