Regulatory Affairs Manager - Cell Therapy
Salary: BRL 120.000 - 160.000
Job 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
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 Regulatory Affairs Director.
The successful candidate, as an individual contributor, will:
Support the definition, setting and oversight of regulatory strategies to maximize regulatory success towards achievement of the program objectives, in conjunction with local, regional, and global teams.
Provide strategic and tactical advice to achieve timely and efficient regulatory submissions, including Advanced Therapy Medicinal Products (ATMP) applications and life cycle maintenance submissions, while ensuring compliance with applicable regulatory requirements and internal policies and standards.
Lead regulatory submissions for new ATMP applications and life cycle maintenance.
Engage with the broader Regulatory community within Gilead.
Contribute to cross-functional initiatives representing the regulatory function and interacting with a diverse number of stakeholders both internal and externally.
Support clinical development programs as a member of a global cross-functional team.
Complete or otherwise provide support in the preparation of routine regulatory submissions for commercial or investigational products in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.
Perform document filing and retrieval functions in accordance with departmental standard operating procedures (SOPs).
Perform workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to others as needed.
With guidance, may participate in the development of routine labeling changes and drug listings.
Contribute to process improvements and/or other special projects within Regulatory Affairs.
Help expedite and improve regulatory administrative activities by training and advising new or less experienced colleagues.
Seek assistance from others as needed.
Ensure own work complies with established practices, policies and processes, and any regulatory or other requirements.
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.
Support the risk assessments on specific local regulatory issues, anticipating potential impacts and risks and proposing solutions including the probability of success.
Accountable for regulatory submissions and approvals and all related activities, in collaboration with internal and external stakeholders, ensuring delivery of the regulatory strategy in Brazil for new applications and life-cycle management.
Initiate and otherwise support local and global process improvements.
Act as point of contact, in support to the direct manager, with health authorities, CTNBio.
Act as a direct point of contact with trade associations, leading and managing the interactions/meetings.
Participate in or lead, with guidance, departmental and cross-functional meetings, taskforces and initiatives.
Actively monitor and anticipate trends that impact the regulatory environment and adapt regulatory strategies in a timely manner.
Review and approve promotional materials in accordance with national legislation and Codes of Practice and company policies and procedures.
Support 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 or MSc in a life sciences or related field with significant regulatory experience (minimum 6 years) 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 complex regulatory strategies and leading regulatory submissions.
Demonstrates strong analytical and critical thinking skills, attention-to-detail, strong communication and writing skills and project management skills.
Experience working in project teams, being capable of effectively interact with internal and external parties to information gather and drive projects through to completion to tight timelines.
Motivated and works independently with limited direction from a senior Regulatory Affairs professional.
Skills & Behaviors
Excellent verbal and written English communication skills, including relevant technical/ATMP language skills.
Excellent interpersonal skills are required to work cross functionally on local and global assignments.
Excellent planning and organizational skills with the ability to work simultaneously on multiple projects with tight timelines.
Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
Planning and information seeking skills and ability to work on specific tasks with some supervision.
Problem solving, strategic thinking skills with ability to impact and influence.
Attention to detail with accuracy and quality.
Ability to understand and effectively engage with external and internal stakeholders.
Self-motivator, enthusiastic, tenacious and energizing.
Proactive and open to share, advise and educate colleagues across the organization.
Gilead Core Values
Integrity (Doing What's Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
Leadership commitments
I AM BOLD in aspiration and AGILE in execution.
I CARE and make time for people.
I LISTEN, speak openly and explain the 'why.'
I TRUST others and myself to make sound decisions.
I OWN the impact of my words and actions.
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