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
 

This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs - Small Molecule Group. Responsibilities and qualifications are as follows:

Responsibilities:

Provides support for designated regional regulatory activities for PDM CMC Project and Commercial Teams, Regulatory Project and Regulatory Submissions Teams, with focus on Small/Synthetic Molecules.Assists designated CMC RA leads in identifying and ranking risks, proposing risk mitigation plans. Shadows leads while they develop and execute robust CMC regulatory strategies.Under the guidance of more senior staff, oversees the preparation of CMC regulatory submissions for investigational and commercial products with solid scientific foundations, in compliance with ICH and regional requirements, and in alignment with company policies and procedures.Will become proficient in utilizing computerizing systems as per established business processes, both within and outside of the GxP environment.Will train and learn how to prepare regulatory submissions which require some interactions with other members in the CMC regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.Will perform workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the CMC regulatory department.Participates in group meetings and provides tactical approaches to addressing issues of low to moderate complexity.May participate in other Subteams and in non-product related projects; may contribute to local process improvements, which have an impact on the working of the CMC Regulatory function or other departments.Learns how to interpret regulatory guidelines and how to comply with statutory requirements.Learns how to provide regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises.Proactively invests in own development to acquire regulatory skills and knowledge, with manager support.Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and regulatory trends.

Basic Qualifications:

Ph.D. in pharmacy, chemistry or related field with 0+ years exp. working in scientific/technical group within a pharma company ORMaster's in pharmacy, chemistry or related field with 2+ years exp. working in scientific/technical group within a pharma company ORBachelor's. in pharmacy, chemistry or related field with 4+ years exp. working in scientific/technical group within a pharma company

Preferred Qualifications:

Ph.D. and 2+ years of relevant industry experience in scientific/technical and an advanced degree. Alternatively, has 5+ years of relevant industry experience in scientific/technical field and a bachelor’s degree with a scientific major.Experience with small molecule/synthetic pharmaceuticals would be preferredCollaborative, proactive, and highly organized approach to work.Demonstrated track record with strategic planning, problem solving, and working within a global matrix team environment.Good understanding of the drug development process.Excellent verbal and written communication skills and ability to interact well with colleagues and stakeholdersExperience in a GMP environment is preferredAbility to learn on the job is preferred

 

The salary range for this position is: $109,650.00 - $141,900.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

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