Regulatory Affairs Lead Cell Therapy Brazil
Regulatory Affairs Lead Cell Therapy Brazil
Brazil - Sao Paulo
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 experienced regulatory professional to join the Regulatory Affairs team built on a strong sense of teamwork and excellence. This position is based in Sao Paulo 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. The role involves close cross-functional collaboration with a diverse number of stakeholders both internally and externally. As an individual contributor you will:
- Define, develop and execute regulatory strategies to maximize regulatory success towards achievement of the program objectives,
- Provide strategic and tactical advice to achieve timely and efficient regulatory submissions NDA and life cycle 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 International project team meetings
Essential Duties and Responsibilities include the following:
- 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 whilst exercising sound judgement and communicating in a timely manner
- Responsible for anticipating and quantifying risks and proposing solutions including 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, CTNBio and trade associations leading and managing the interactions/meetings
- Accountable for establishing strong working relationships with the regulatory central team, other functions as required and to serve as the point contact for Brazil cell therapy programs to these key stakeholders
- Participate in or lead departmental and cross-functional taskforces and initiatives
- Actively monitor and anticipate trends that impact the regulatory 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
- Review and approve promotional materials in accordance with national legislation and Codes of Practice and company policies and procedures.
- Establishes and supports maintenance of GDP, Importer's and Wholesaler's license and Quality Agreements related to cell/gene therapy product(s).
- Responsible for demonstrating Gilead leadership commitments
Education & Experience:
- BSc, MSc or PhD in a scientific discipline with extensive experience in the pharmaceutical/biotechnology industry in Brazil
- Experience in cell therapy will be an advantage
- Extensive knowledge of regulatory requirements in biologicals (highly desirable in the field of cell therapy) and in managing close interactions with HA.
- Experience in developing and implementing complex regulatory strategies.
- Experience in critically reviewing complex technical documents and influencing colleagues across functions towards successful implementation of regulatory plans.
Skills & Behaviors
- Self-motivator, enthusiastic, tenacious and energizing.
- Proactive and open to share, advise and educate colleagues across the organization.
- Agile in an evolving environment.
- Resilient with the ability to influence and deliver in an ambiguous environment.
- Ability to engage stakeholders and manage multiple stakeholders to achieve the objective.
- Ability to transition from strategic to operational in order to deliver objectives according to established plans and business needs.
- Excellent verbal & written English, negotiation, influence and interpersonal communication skills
- A good team player.
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.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Brazil---Sao-Paulo/Regulatory-Affairs-Lead-Cell-Therapy-Brazil_R0020860
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