Regulatory Affairs Specialist

2 weeks ago

Pierre, South Dakota, United States Bausch + Lomb Full time
About the Role

Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world. We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our CMC team.

Key Responsibilities
  • Develop and implement global CMC regulatory strategies for submissions and content of CMC dossiers for prescription drugs and consumer products.
  • Collaborate with R&D and Quality organizations to prepare and maintain CMC sections of submissions and respond to Health Authority queries throughout the product lifecycle.
  • Ensure regulatory compliance and change management.
  • Communicate CMC regulatory strategy, key issues, and critical topics to interdisciplinary project teams and management levels.
  • Lead and drive all CMC submission activities, including planning, authoring, reviewing, coordination, and submission.
  • Negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
  • Provide regulatory support to other company functions during Regulatory Authority inspections.
  • Review and provide input on proposed health authority guidance documents on CMC issues.
  • Author annual reports for non-marketed Rx products and provide the CMC portion of Annual Product Reviews.
Requirements
  • Bachelor's degree or equivalent.
  • Minimum 3 years of Regulatory Affairs experience or relevant experience in a regulated environment.
  • Excellent communication, interpersonal, and writing skills.
  • Self-motivated and capable of working independently with minimal supervision.
  • Skilled in basic technologies, including MS Office Applications, Adobe Acrobat, and MS Project.
  • Knowledge of country regulations, post-market surveillance, ISO, and IEC.
  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
  • Command of the English language (verbal and written).
  • Ability to understand scientific information and assess whether technical arguments are articulated clearly.
  • Experienced in good documentation practices and requirements for managing regulated records.
What We Offer
  • Competitive salary and excellent benefits, including medical, dental, eye health, disability, and life insurance.
  • 401K Plan with company match and ongoing company contribution.
  • Paid time off, floating holidays, and sick time.
  • Employee Stock Purchase Plan with company match.
  • Employee Incentive Bonus.
  • Ongoing performance feedback and annual compensation review.

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