Clinical Research à United States

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s 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 we’re 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

POSITION OVERVIEW

The global regulatory affairs team is responsible for supporting Gilead to make sound strategic decisions to enable access for patients to our molecules.

The position is in the Virology IC/GPS Franchise which is responsible for the Intercontinental and Gilead Patient Solutions region, working across territories throughout Asia, Latin America, Africa, Eastern Europe and the Middle East.

Working within the global team, you will act as the Regional Regulatory Lead leading, managing and overseeing complex regulatory strategies for one/multiple products or projects in the Virology therapeutic area. You will shape and help define the regulatory strategy, plans and objectives for assigned products or projects. Your responsibilities will involve managing regulatory submissions and other projects, representing the IC/GPS regulatory franchise on cross-functional core and sub-teams.

You will provide strategic and technical advice from development throughout the whole product lifecycle for HIV, Hepatitis and/or Emerging Viruses projects/products.

You will oversee preparation and maintenance of regulatory submissions, regulatory for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.

EXAMPLE RESPONSIBILITIES:

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

• Oversee and leads regulatory strategies for designated products in the region. This ranges from new product licenses to lifecycle activities.

• Oversee and guides the preparation, compilation, and timely filing of regulatory submissions and approves the authoring of regulatory documents as required and critically reviews documents for submission to regulatory authorities

• Oversee preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensure that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.

• Oversee and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets. Make significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.

• Partner both within regulatory affairs and throughout the development and commercial organization. Collaborate with cross-functional partners to ensure optimal execution of the agreed regulatory strategy.

• Establish strong relationships with Gilead affiliates and distributor partners and serve as point person for knowledge for their product to these key stakeholders.

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

• Participate and lead collaborative efforts across function in process improvement initiatives.

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

• Have a good understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence.

• Participate and contribute to regulatory team meetings and be recognized as a knowledgeable resource for Regulatory Affairs in other departments.

• Understand and working knowledge of the use internal electronic systems for planning, preparing, tracking and archiving submissions to regulatory agencies.

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

BA/BS or advanced degree in life sciences or related field with regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.

Knowledge & Other Requirements

• In-depth working regulatory knowledge, including ICH and regional requirements.

• An in-depth of current global and regional trends in Regulatory Affairs with proven effectiveness in applying this knowledge to optimize team deliverables.

• Previous experience of working with emerging markets and/or in the Virology therapeutic area would be an advantage but not essential.

• Methodical attention to detail.

• Must have a “can do” attitude and be “hands on” as and when required.

• Proven track record to manage, formulate and execute strategy.

• Strong interpersonal skills and understanding of team dynamics.

• Strong communication and organizational skills.

• Strong negotiation and conflict resolution skills.

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, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s 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.