Specialist Regulatory Affairs Brazil
Specialist Regulatory Affairs 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 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 Gileads 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 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 Gileads 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 Gileads 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;
- A of minimum 5 years 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.
Gilead Core Values
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
For Current Gilead 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/Specialist-Regulatory-Affairs-Brazil_R0021103
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