Director, 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

As a Director Virology Global Regulatory Affairs you will develop and execute regulatory strategies for products across the virology portfolio in alignment with the global regulatory strategies in collaboration with Franchise Leads and cross-functional stakeholders in compliance with the appropriate regulations. You will act as the Global and/or Regional Regulatory Lead on complex or multiple products compounds indications or projects in the assigned therapeutic area. You will typically be assigned a portfolio of products or projects in the virology therapeutic area which you will manage and oversee simultaneously. You will define the regulatory strategy plans and objectives for assigned products or projects. Though the role is primarily focused on assets in the virology therapeutic area you may also support programs across other therapeutic areas such as inflammation and oncology depending on business needs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global Regulatory Affairs on cross-functional core and sub-teams including Project Strategy Teams. You will oversee preparation and maintenance of regulatory submissions regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will provide operational and technical regulatory assistance through all stages of clinical development through global registration and maintenance as needed. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help develop the Regulatory Liaison team and talent through coaching and mentoring other Regulatory colleagues and regional leads.

EXAMPLE RESPONSIBILITIES:

• Accountable for the successful oversight and completion of a broad spectrum of regulatory activities and deliverables for products compounds indications and/or other projects in the virology therapeutic area.

• As needed represents Gilead in negotiations with regulatory authorities. Oversees contacts for and/or may serve as a direct contact with local regulatory authorities.

• Works on extremely complex problems and provides solutions that have significant impact.

• Makes significant contributions to the ongoing development and refinement of regulatory strategies processes standards practices efficiencies and capabilities.

• Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams and Project Strategy Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.

• Advises other functions on short- and long-range regulatory strategies plans resources and tactics as the global regulatory representative in cross functional meetings such as the program strategy team and global development team.

• May participate on other Sub-teams (e.g. Study Management Clinical Nonclinical Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.

• Defines oversees and communicates the regulatory strategy for assigned products or projects.

• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.

• Oversees and guides the preparation compilation and timely filing of regulatory submissions which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests briefing packages original Investigational New Drug (IND) IND amendment original New Drug Application (NDA) supplemental NDAs and routine submissions (e.g. Development Safety Update Reports / DSURs Investigator Brochure/ IB updates etc.).

• Oversees the authoring and approval of regulatory documents including meeting requests Module 1 documents for original IND/NDA etc.

• May oversee and guide labeling packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.

• Critically reviews documents for submission to regulatory authorities.

• May have one or more direct report.

• Provides matrix management and leadership to project teams.

• Provides accurate and thorough input and recommendations into resource plans required to complete team deliverables. Tracks resources to ensure compliance with agreed resource allocation including budgets.

• Ensures own work complies with established practices policies and processes and any regulatory or other requirements.

REQUIREMENTS:

We are all different yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

U.S. Education & Experience

• PharmD/PhD with 8 years relevant experience.

• MA/MS/MBA with 10 years relevant experience.

• BA/BS with 12 years relevant experience.

• Extensive regulatory quality compliance or related experience in the biopharma industry.

• Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.

• Extensive experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.

• Experience and proven effectiveness working and negotiating with regulatory authorities.

• Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.

• Line management (direct reports) experience is strongly preferred.

• Proven track record of effective people leadership and management as evidenced through past effectiveness with employee engagement development and retention either with direct reports or through matrix leadership responsibilities.

• Proven track record of successfully managing large scale complex time-sensitive projects.

• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.

Rest of World Education & Experience

BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry regulatory agency clinical research or other related healthcare environment. Experience in in vitro diagnostic development strongly preferred

Knowledge & Other Requirements

• Expert knowledge of the drug development process global and regional regulatory requirements for medicinal products.

• Expert knowledge of all key functions involved in the various stages of drug development from early research through post-marketing.

• Demonstrates advanced regulatory and business knowledge and advanced analytical abilities as evidenced by strengths in assessing complex multidisciplinary data understanding and effectively advising on its regulatory implications.

• In-depth knowledge of relevant health authorities (HAs) including people system processes and requirements as evidenced by past effectiveness and successes in conducting HA interactions.

• Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.

• Strong leadership presence with demonstrated ability to lead without authority and influence programs projects and/or initiatives.

• Strong interpersonal skills and understanding of team dynamics.

• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels including leadership teams executives and steering committees.

• Strong negotiation and conflict resolution skills.

• Strong coaching capabilities to mentor/develop staff.

• When needed ability to travel.

The salary range for this position is:

Gilead considers a variety of factors when determining base compensation including experience qualifications and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus discretionary stock-based long-term incentives (eligibility may vary based on role) paid time off and a benefits package. Benefits include company-sponsored medical dental vision and life insurance plans*.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

For jobs in the United States:

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For more information about equal employment opportunity protections please view theKnow Your Rights poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.