Regulatory Affairs Associate Director Cell Therapy Program
Regulatory Affairs Associate Director Cell Therapy Program
UAE - Dubai
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
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
- Accountable 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 accordance with the product license.
- Ensure implementation of serialization project and Track & Trace system, in collaboration with relevant internal & external stakeholders
- Maintain deep knowledge of country regulatory requirements and the impact thereof on cell therapy and communicate changes to project teams and senior management in a timely manner.
Regulatory Compliance & Quality
- Managing product complaints, as needed
Access / commercial cross functional support
- Partner with market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product-specific value evidence topics, as applicable
- Provision of guidance during preparation of promotional materials & activities; review and approve promotional materials in accordance with national legislation and Codes of Practice and company policies and procedures.
Skills and Requirements
- Must be knowledgeable of regulatory environment and guidelines in the Kingdom of Saudi Arabia
- Has a broad understanding of pharmaceutical manufacturing, change control, and global distribution systems
- Experienced with liaising with local distributor and regulatory authorities with consideration given to the broader impact of decisions or issues arising from these interactions
- Outstanding collaborative, problem solving team player with excellent written and oral communication and organizational skills
- Able to articulate complex regulatory affairs strategies and issues at all levels within the Company.
- Strong attention to detail, and history of success leading and working on multiples projects with tight deadlines
- Must be able to facilitate effective interactions within International Regulatory Affairs and with other departments and sites within the company, and with external organisations such as national authorities, distributors, trade associations and professional bodies.
Education and Experience:
- BS, MS or PhD in a scientific discipline with 10+ years' biotech and pharmaceutical Regulatory Affairs experience
- Experience in Cell Therapy would be an advantage
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system\'s ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws including nationalization and residency restrictions and requirements). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Kite Pharma Employees and Contractors:
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/UAE---Dubai/Regulatory-Affairs-Associate-Director-Cell-Therapy-Program_R0020827
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