Director Regulatory Affairs Labeling Compliance

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Job Description

FUNCTION: Regulatory Affairs (RA) Labeling

POSITION OVERVIEW:

Regulatory Affairs Labeling is a core function within Gileads Global Regulatory Affairs organization and acts as a critical strategic partner across crossfunctional teams. Regulatory Affairs Labeling creates updates and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gileads ongoing compliance with governing laws regulations and company policies and procedures. Product information and labeling documentation contains the most accurate product use benefits dosage/application and safety information such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with crossfunctional partners to ensure timely and appropriate delivery of product information and labeling updates including other Development teams Legal Commercial and external regulatory agencies.

You will play a key role in advancing compliance excellence within the Global Labeling team at Gilead. This position will focus on optimizing tools systems and processes to support proactive compliance management. Collaborating closely with Global Labeling Regulatory Patient Safety and Manufacturing teams you will ensure the seamless of labeling changes and provide critical support during global audits and inspections.

As an individual contributor you will work crossfunctionally across Gilead and with strategic partners to enhance the efficiency accuracy and compliance of Company Core Data Sheets (CCDS) alignment distribution as well as the tracking of labeling changes.

This newly created role within the Innovation Content and (ICX) team carries significant responsibility for shaping and evolving global regulatory and labeling policies tools procedures and capabilitiesdriving continuous improvement and innovation across Gilead.

EXAMPLE RESPONSIBILITIES:

• Operational Excellence:

  • Oversee the development and management of implementation of global labeling and review processes metrics and systems.

  • Provide oversight of country labeling deviations from the CCDS through reporting and collaboration with Global Labeling Leads.

  • Support the design implementation and continuous improvement of standardized processes Standard Operating Procedures (SOPs) and work instructions related to labeling compliance and tracking.

  • Work to optimize the workflow for the distribution and tracking of CCDS ensuring seamless communication and across all departments.

  • Provide guidance to liaison and affiliate teams on the implementation of labeling changes ensuring consistency and quality at every stage of the product lifecycle.

  • Develop key performance indicators (KPIs) and identify opportunities for further operational improvements driving a culture of continuous improvement within labeling.

• Innovation in Tools and Technologies:

  • Support key initiatives aimed at identifying evaluating and implementing new tools technologies and systems for the distribution of global labeling changes.

  • Support the integration of advanced tools for efficient management of CCDS distribution regulatory tracking and labeling change implementations across multiple affiliates.

  • Inform Gilead on emerging technologies within regulatory labeling to ensure the use of stateoftheart tools which will reduce lead time and improve the accuracy of labeling updates globally.

• Proactive Compliance Management:

  • Support the development and compliance to labeling processes in place to meet global regulatory requirements and internal compliance standards.

  • Proactively track and report on safetyrelated changes to labeling ensuring that the most current and accurate information is consistently reflected in CCDS documents.

  • Monitor and maintain auditready documentation for labeling activities ensuring that all changes are traceable and fully compliant with local and international regulations.

  • Collaborate with stakeholders to ensure compliance with regulatory bodies and inspections providing necessary data when required.

  • Support the LAT and Pharmacovigilance team during regulatory inspections and audits ensuring the accuracy and availability of relevant labeling documentation.

• Impactful :

  • Collaborate with Labeling Liaisons Affiliates and PDM to ensure all packaging and labeling changes are executed within required timelines.

  • Manage the tracking and coordination of labeling activities including artwork approvals change management and regulatory assessments.

  • Ensure that all internal stakeholders including regulatory affairs legal and marketing teams are aligned and aware of any updates to labeling and packaging requirements.

  • Prioritize tasks effectively ensuring that labeling changes are implemented on schedule to meet regulatory deadlines and support successful product launches.

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.

Education & Experience

• Extensive experience in prescription drug labeling. Extensive experience leading development of end to end labeling process regulatory labeling or related strategies leading crossfunctional regulatory activities and representing Regulatory to crossfunctional leaders and teams for multiple medicinal products.

• Significant experience in global management of drug labeling including core labeling and regional labeling across U.S. EU GB Australia Canada Japan Switzerland and other markets.

• Experience leading global teams and projects in regulatory or related strategies programs projects and other activities.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs companysponsored training education assistance social and recreational programs are administered on a nondiscriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.