Regulatory Compliance Manager
3 days ago
Catalent is a global drug development and delivery leader that produces more than 70 billion doses per year. The company is dedicated to advancing new medicines from early development to clinical trials and to the market.
Job Summary
This is a full-time on-site position with Monday-Friday hours from 8:00am to 5:00pm. The role involves overseeing customer Quality Agreements, supporting customer audits, maintaining facility licenses and registrations, and organizing documentation in support of client regulatory submissions.
Key Responsibilities
- Oversight of internal and client audits as well as regulatory agency inspections.
- Facilitation of Quality Agreement development and approval.
- Coordinating audits with the customer and internal stakeholders.
- Maintenance of facility licenses and registrations.
- Organization of documentation in support of client regulatory submissions.
Required Skills and Qualifications
- Doctorate Degree in STEM discipline or equivalent experience.
- Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.
- Ability to use Excel, Word, and other office systems.
- Detail-oriented and well-organized with ability to work under high pressure.
Why Work at Catalent?
- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- 152 hours of paid time off annually + 8 paid holidays.
- Competitive salary with yearly bonus potential.
- Community engagement and green initiatives.
- Generous 401K match and Paid Time Off accrual.
- Medical, dental and vision benefits effective day one of employment.
- Tuition Reimbursement.
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