Regulatory Affairs Specialist

4 days ago

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

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-from the moment of birth through every phase of life.

Our mission is simple, yet powerful: helping you see better, to live better. We have a comprehensive portfolio of over 400 products that is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives.

We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.

We are well positioned to continue leading the advancement of eye health in the future.

As a member of our global technical CMC team, you will be responsible for global regulatory CMC strategy for submissions and content of CMC dossiers for prescription drugs and consumer products. You will liaise with R&D and Quality organizations to prepare and maintain CMC sections of submissions and respond to Health Authority queries throughout the product lifecycle.

You will be responsible for regulatory compliance and change management, as well as regulatory intelligence surveillance and US regulatory licensing. You will proactively communicate CMC regulatory strategy, key issues, and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs, R&D, TechOps, and Supply Chain as appropriate in a timely manner.

Key responsibilities include:

  • Leading and driving all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
  • Identifying, as early as possible, the required documentation and any content, quality, and/or timeline issues.
  • Coordinating with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
  • Providing regulatory support to other company functions during Regulatory Authority inspections.
  • Serving as Regulatory Affairs representative on facility/site Local Change Management Boards.
  • Reviewing and providing input on proposed health authority guidance documents on CMC issues.
  • Working closely and collaborating with CMC Managers & Product Leads on international market requests.
  • Acting as primary contact with regulatory authorities with limited supervision.

Requirements include:

  • 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.
  • 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.
  • Demonstrated ability to contribute to a continuous learning and process improvement environment.
  • Some knowledge of how create a successful product regulatory strategy.

We offer a competitive compensation package, including medical, dental, eye health, disability, and life insurance, paid time off, employee stock purchase plan, tuition reimbursement, and ongoing performance feedback and annual compensation review.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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