Regulatory Affairs Assoc II CMC

2 days ago

Foster City, United States Gilead Sciences, Inc. Full time

Regulatory Affairs Assoc II CMC - Small Molecules This role of Regulatory Affairs Associate II, CMC is within Gilead's CMC Regulatory Affairs - Small Molecule Group. Responsibilities and qualifications include: Responsibilities: Support regional regulatory activities for PDM CMC Project and Commercial Teams, focusing on Small/Synthetic Molecules. Assist CMC RA leads in risk identification, ranking, and mitigation plans. Shadow leads in developing and executing CMC regulatory strategies. Under supervision, oversee preparation of CMC regulatory submissions for investigational and commercial products, ensuring compliance with ICH, regional requirements, and company policies. Learn to utilize computer systems aligned with business processes within and outside GxP environments. Assist in preparing regulatory submissions and interacting with team members, adhering to ICH and regional guidelines. Manage document workflows, tracking, indexing, retrieval, and information dissemination within the CMC regulatory department. Participate in meetings, providing tactical approaches for issues of low to moderate complexity. Contribute to process improvements and participate in other projects as appropriate. Learn to interpret regulatory guidelines and ensure compliance with statutory requirements. Assist in regulatory impact assessments and technical risk evaluations. Invest in personal development to acquire regulatory skills and knowledge, with managerial support. Develop understanding of CMC regulatory intelligence, guidelines, and trends. Basic Qualifications: Ph.D. in pharmacy, chemistry, or related field with 0+ years of experience in a scientific/technical role within a pharma company OR Master's degree in pharmacy, chemistry, or related field with 2+ years of relevant experience OR Bachelor's degree in pharmacy, chemistry, or related field with 4+ years of relevant experience. Preferred Qualifications: Ph.D. with 2+ years of industry experience or 5+ years of relevant experience with a bachelor’s degree. Experience with small molecule/synthetic pharmaceuticals is preferred. Proactive, organized, and collaborative work approach. Experience with strategic planning, problem-solving, and working in a global matrix team. Good understanding of drug development processes. Excellent communication skills and stakeholder interaction. GMP experience is preferred. Ability to learn on the job is advantageous. Share:Job Requisition ID R Full Time/Part Time: Full-Time Job Level: Associate Click below to return to the Gilead Careers site Click below to see upcoming events Click below to return to the Kite, a Gilead company Careers site #J-18808-Ljbffr

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