Sr Regulatory Affairs Associate

Gilead Sciences Farmaceutica do Brasil Ltda; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A biotechnology firm in São Paulo is seeking a Regulatory Affairs Sr. Associate to lead regulatory maintenance and collaborate cross-functionally. Ideal candidates will have a Pharmacist or Biochemistry degree and extensive experience in the pharmaceutical industry. Responsibilities include managing regulatory strategies, supporting compliance, and monitoring regulations. This position requires a self-motivated and resilient individual who excels in negotiation and teamwork, ensuring that business needs meet regulatory requirements.

Qualificações

• Extensive experience in the pharmaceutical / biotechnology industry, especially in R&D.
• Thorough understanding of post-registration changes and line extensions regulations.
• Ability to develop and implement complex regulatory strategies.

Responsabilidades

• Support regulatory strategies for maintenance of registered products.
• Manage GMP applications and renewals.
• Review promotional materials according to local regulations.
• Monitor regulatory changes and inform stakeholders.

Conhecimentos

Regulatory compliance

Creative problem-solving

Negotiation skills

Stakeholder engagement

Team collaboration

Fluent in English

Formação académica

Pharmacist / Biochemistry degree

Descrição da oferta de emprego

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

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.

For Current Gilead Employees and Contractors

Please apply via the Internal Career Opportunities portal in Workday.