Associate II, Regulatory Affairs
Specific Responsibilities and Skills for Associate II, Regulatory Affairs
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
As a member of the Foster City Drug Substance Regulatory Strategy (DSRS) team, duties will include the following:
• Collaborate with process chemistry and analytical operations teams to implement efficient experimental approaches to facilitate construction, alignment, and maintenance of API control strategies to meet current and upcoming regulatory requirements.
• Author drug substance sections of clinical trial and marketing authorization applications and supplements (e.g. IND, IMPD, CTA and marketing applications NDA, MAA, JNDA, CNDA) in collaboration with various contributors and stakeholders.
• Prepare response to questions related to manufacturing sections and contribute to content and responses for other control topics.
• Facilitate the potentially mutagenic impurity assessment process in accordance with ICH M7.
• Facilitate the API nitrosamine risk assessment process in collaboration with the appropriate stakeholders.
• Compile API elemental impurity assessment summary.
• Advise development teams on the selection and justification of regulatory starting materials.
• Identify key regulatory issues with potential cross-project impact and raise awareness with and appropriately influence affected teams as required.
• Support the maintenance of API control strategies throughout a program’s life-cycle.
• Provide training to project teams on good writing practices for regulatory and project documentation.
Essential Functions
- Develop control strategies and the preparation of technically complex drug substance sections of regulatory submissions in line with ICH and regional regulatory requirements in collaboration with other chemistry manufacturing and control (CMC) functional areas (for example: process chemistry, outsourced manufacturing, analytical operations, CMC regulatory affairs).
- Contribute to a variety of regulatory submissions which may include clinical trial and marketing authorization applications and supplements and responses to agency questions.
- Participate in DSRS group meetings and present project status, strategic approaches and updates for complex projects.
- Attend and participate in cross-functional CMC sub-team meetings for supported clinical and commercial projects.
- May identify and implement improvements to group processes to optimize productivity and regulatory outcomes.
- May present at department-wide meetings and provide relevant training to key stakeholders.
Knowledge, Experience and Skills
Basic Qualifications
- Master's Degree with 2+ years of experience in regulatory affairs in biotech/pharma industry Or
- Bachelor's Degree with 4+ years or experience in regulatory affairs in biotech/Pharma industry Or
- AA Degree with 5+ years of experience in regulatory affairs in biotech/pharma industry Or
- High School Diploma with 6+ years of experience in regulatory affairs in biotech/pharma industry
Preferred Qualifications
- Advanced degree desired
- Good organizational skills and ability to work on a number of projects in alignment with timelines.
- Strong verbal and written communication skills
- Excellent interpersonal skills
- Proactive and solution-oriented
- Basic understanding of the role of Regulatory Affairs and familiarity with regulatory requirements for development of drug and biological products, including FDA and ICH guidelines
- May act as a resource on a specific topic for other Regulatory personnel within the department.
- Work is performed under the direct supervision of Regulatory Affairs professionals following detailed instruction with well-defined procedures.
- Experience in process chemistry is desirable.
- Familiarity with the concepts of design of experiment including statistical methods, study design and data analysis is a plus.
About Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.
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