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
Position: Regulatory Affairs Sr. Associate in São Paulo, Brazil
We are looking for a regulatory affairs professional who is passionate about biotechnology and with creative problem-solving skills to seamlessly meet the business needs while maintaining regulatory compliance.
This is an opportunity 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 maintenance of Gilead´s current portfolio working close to local and international areas such as CMC, Supply Chain, Quality Assurance and others. As such, the role involves close cross-functional collaboration and requires a high sense of urgency, negotiation skills and organization.
Essential Duties and Responsibilities include the following:
As an individual contributor you will:
Support the definition, development and execution of regulatory strategies for maintenance of registered products, including variations, line extensions, labelling updates, renewals and annual reports.
Manage GMP applications and renewals; maintenance of legal documents (operating license and CRF);
Manage labeling and artwork updates;
Support monitoring competitors as part of the regulatory intelligence activities;
Provide proper regulatory advice to main stakeholders considering business needs and assuring no commercialization disruption due to variations, as applicable;
Monitor regulations and changes in the regulatory environment and participate on discussions related to regulation changes (Trade Associations, ANVISA) in order to keep the internal stakeholders updated on potential risks and opportunities that could impact ongoing and future projects.
Lead internal discussions and projects to support public consultations to capture Gilead´s contributions for shaping the regulatory environment and, for new regulations, support and assure the implementation of Brazilian requirements;
Review and approve promotional and non-promotional materials according with local regulations, ethics code and Gilead´s business conduct.
Support local processes improvements and contributes to local and/or global processes improvements which have a significant impact for RA and other departments; assess proposed changes to local procedural documents and impact on existing process.
Education & Experience:
Pharmacist / Biochemistry degree;
Extensive experience in the pharmaceutical/biotechnology industry and in particular R&D companies;
Fluent in English;
Extensive knowledge and proven experience on post-registration changes / line extensions / labeling updates regulations, including the new API framework.
Extensive experience in small molecules regulation and desirable experience in biologics regulations.
Experience in developing and implementing regulatory requirements and complex regulatory strategies.
Skills & Behaviors
Sense of urgency and priorities.
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.
Excellent verbal & written English, negotiation, influence and interpersonal communication skills
A good team player.
Please apply via the Internal Career Opportunities portal in Workday.