Sr Manager, Regulatory Affairs

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

Essential Duties and Responsibilities include the following:

As an individual contributor the Senior Manager will:

Lead and own the development execution and oversight of local regulatory strategies for registered products and pipeline assets ensuring alignment with global and regional regulatory objectives.

Provide strategic and tactical regulatory advice to internal stakeholders to enable timely and compliant product registration variations line extensions labeling changes renewals and other lifecycle management activities.

Act as regulatory lead for complex submissions and initiatives ensuring endtoend accountability for regulatory outcomes and deliverables in Brazil.

Serve as a regulatory interface with ANVISA and other relevant external stakeholders leading health authority interactions negotiations and regulatory discussions in alignment with Gilead policies and standards.

Proactively monitor analyze and interpret changes in the regulatory environment identifying risks and opportunities and translating them into actionable regulatory strategies.

Lead regulatory risk assessments anticipating potential impacts to business objectives and proposing mitigation strategies including assessment of probability of success.

Represent Regulatory Affairs in crossfunctional and crossregional initiatives providing expert regulatory input to support clinical development commercial strategy and supply continuity.

Provide regulatory intelligence and thought leadership contributing to internal discussions trade associations and public consultations supporting the shaping and implementation of regulatory requirements in Brazil.

Review and approve promotional and nonpromotional materials in compliance with local regulations ethical standards and Gileads Business Conduct policies.

Drive and contribute to continuous improvement initiatives supporting local regional or global regulatory process enhancements with meaningful functional or business impact.

Demonstrate Gileads Leadership Commitments and Core Values through daily behaviors and professional conduct.

Education & Experience:

Bachelors degree in Pharmacy / Biochemistry degree. Advanced degree is desirable.

Minimum of 810 years of progressive regulatory affairs experience in the pharmaceutical or biotechnology industry with strong exposure to Brazilian regulatory requirements.

Demonstrated experience in developing and executing complex regulatory strategies and leading regulatory submissions and lifecycle management activities.

Proven experience interacting with health authorities and managing regulatory negotiations.

Fluency in English is required.

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 Whats 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.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.