Regulatory Affairs Specialist

4 days ago


Charleston, West Virginia, United States Bausch + Lomb Full time
Job Summary

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.
Requirements
  • 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.
What We Offer
  • 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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