Regulatory Affairs Specialist

4 weeks ago


Dover, Delaware, 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 implement global CMC regulatory strategies for submissions and content of CMC dossiers.
  • Collaborate with R&D and Quality organizations to prepare and maintain CMC sections of submissions.
  • Respond to Health Authority queries throughout the product lifecycle.
  • Ensure regulatory compliance and change management.
  • Provide regulatory support to other company functions during Regulatory Authority inspections.
  • Represent Regulatory Affairs on facility/site Local Change Management Boards.

Requirements:

  • Bachelor degree preferred or equivalent.
  • Minimum of 3 years 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 (e.g., MS Office Applications, Adobe Acrobat, MS Project).
  • Knowledge of country regulations (med device and pharma), post market surveillance, ISO and IEC.
  • Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies.
  • Command of 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.
  • Demonstrated ability to contribute to a continuous learning and process improvement environment.

We Offer:

  • Competitive salary & excellent benefits including Medical, Dental, Eye Health, Disability and Life Insurance.
  • 401K Plan with company match and ongoing company contribution.
  • Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time.
  • Employee Stock Purchase Plan with company match.
  • Employee Incentive Bonus.
  • Tuition Reimbursement (select degrees).
  • Ongoing performance feedback and annual compensation review.

About Us:

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.



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