Regulatory Affairs Associate - II(CMC)
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Job Location:
Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Role & Responsibilities:
- Masters degree in pharmacy chemistry or related field with 3 years of relevant experience.
- 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.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
