Regulatory Affairs Assoc II CMC - 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  R0046536

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