Regulatory Affairs Specialist
4 days ago
Bausch + Lomb is seeking a highly skilled Regulatory Affairs Specialist to join our global team. As a key member of our CMC strategy team, you will be responsible for developing and implementing regulatory strategies for prescription drugs and consumer products.
Key Responsibilities- Develop and maintain CMC sections of submissions and respond to Health Authority queries throughout the product lifecycle.
- Collaborate with R&D and Quality organizations to prepare and maintain CMC sections of submissions.
- Ensure regulatory compliance and change management for pharmaceutical products.
- Provide regulatory support to other company functions during Regulatory Authority inspections.
- Review and provide input on proposed health authority guidance documents on CMC issues.
- Bachelor degree preferred or equivalent.
- Minimum of 3 years Regulatory Affairs experience or relevant experience in a regulated environment.
- Excellent communication and interpersonal skills.
- Self-motivated and capable of working independently with minimal supervision.
- Knowledge of country regulations, post market surveillance, ISO and IEC.
- Competitive salary and excellent benefits package.
- 401K Plan with company match and ongoing company contribution.
- Paid time off – vacation, floating holidays and sick time.
- Employee Stock Purchase Plan with company match.
- Employee Incentive Bonus.
- Tuition Reimbursement (select degrees).
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