Gilead Sciences, Inc.
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.
Job Requisition ID R
Full Time/Part Time: Full-Time
Job Level: Associate
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